What is an Informed Consent?

Informed Consent

So, suppose you want to participate in a clinical trial. When you inquire for more information and decide to come in for a screen visit you will be asked to sign what is called an Informed Consent. But, what exactly is this piece of document?

An informed consent for a clinical trial is a document that explains the risks and benefits to a volunteer about participating in a clinical trial. It is important to read and understand the consent and have time to ask any questions prior to signing the document. The informed consent should be looked as a process where the participant should interact with the investigator and his delegates so all parties understand their responsibilities and rights.

This document is developed by the research institute following FDA guidelines and is reviewed and approved by the Institutional Review Board prior to the start of the subject recruitment process and modified if additional risks or adverse effects are added to the tested product. However, even if you initially sign this document you always have the chance to withdraw from the study at any given time for any reason.

 

The FDA guidance lists the elements that should be included in the consent and they include:

  1. A statement explaining that the study involves research and what the purpose of the trial is.
  2. It should list what occurs at each study visit and if any experimental procedures is involved.
  3. Description of any potential risks from participating in the study.
  4. Description of potential benefits to study participants as well and to individuals with similar medical issues not participating in the study.
  5. Disclosure of other potential alternative treatments to participating in the study.
  6. Statement about volunteers information and records will be kept confidential and the FDA can inspect the records
  7. Statement about whether compensation is available if an injury occurs to someone participating in a trial and what process to follow if a medical injury or side effect occurs.
  8. A statement describing who to contact for study related questions and who to contact in case of injury.
  9. A statement that research is voluntary and that an individual can discontinue their participation for any reason at anytime without a penalty.
  10. A statement that research may contain unforeseen risks to both, the participant and potentially to an unborn fetus.
  11. Circumstances by which a participant can be discontinued from a study without their consent.
  12. Any potential costs from participating in a study.
  13. Statement that any knew information that is learned will be disclosed to participants.
  14. Number of participants in the study.

 

There are many people that are skeptical about participating in clinical trials because of safety reasons. It is important to remember that the main concern for any study site is to keep subject safe at all times. In my next blog I will discuss more about your safety during these types of studies. Stay tune for more!

-Dr. Howard Schwartz M.D. – Gastroenterologist

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Five Things You Did Not Know About Vitamin C

 

Citrus ImageVitamin C is a very popular vitamin, perhaps even the best known and selling vitamin worldwide. We are told from the time we are children that vitamin C is good for you, that we need to make sure to get enough vitamin C for health, strength and our immune system. Some people claim vitamin C can prevent colds (it cannot), cure cancer (it does not, but under certain circumstances may aid treatment to work better), and that vitamin C is the strongest antioxidant (it also, is not).

 

Historically vitamin C is best known for its ability to cure scurvy. Scurvy at one time was a prevalent disease in sailors. In probably the first clinical trial to ever happen on the open seas, James Lind in 1747 took 12 sailors who had scurvy and treated them with six different interventions. The only intervention that was effective for scurvy was oranges and lemons. This discovery, later validated via repeat work, was the start of the discovery of one property of vitamin C.

 

  1. Has vitamin C always been known as vitamin C? NO! In fact, vitamin C was first called “hexuronic acid”. Vitamin C did not become an official name for the vitamer until 1933.
  2. Humans can synthesize their own vitamin C. In fact, this is also NOT TRUE! For humans, vitamin C must be obtained through the diet, through foods or beverages that we eat. The closest things to a human, which synthesizes vitamin C internally and does not need it from the diet, are canines (dogs).
  3. Pasteurization is safe for vitamin C. No, No, No! Not true! Pasteurization while needed for food safety from a public health standpoint, actually destroys any naturally occurring vitamin C in the food that is about to be pasteurized. Any vitamin C you find in a pasteurized food is added after pasteurization, thus is supplemental, not natural.
  4. Smoking depletes the body of vitamin C. Yes this is true. Each cigarette or equivalent depletes the body of about 25mg of vitamin C. This is also one reason why health professionals recommend extra or higher amounts of vitamin C for people who smoke. Another reason smoking is no good for you.
  5. The current recommendations for daily vitamin C dietary levels are from 90 mg per day to no more than 2 grams per day. One orange typically can supply the days need for vitamin C. There are great many foods which are rich in vitamin C, to learn more, click on this link: http://www.whfoods.org/genpage.php?tname=nutrient&dbid=109

 

The above “fun facts” are designed to teach a little about vitamin C while also providing some guidance on how much to aim for daily through your diet or diet plus use of supplemental nutrition.

 

To Your Health!

 

-Douglas Kalman PhD, RD, FACN

 

For more great health information – please follow us on Twitter

@Miami_Nutrition

@dougkalmanphdrd

 

References:

 

  1. http://en.wikipedia.org/wiki/Vitamin_C#cite_note-US_RDA-81
  2. http://www.whfoods.org/genpage.php?tname=nutrient&dbid=109

 

 

What is a drug study or clinical trial?

Clinical Trial 2

When you hear radio or TV commercials promoting studies to test new drugs or products, have you ever wonder what do these studies exactly consist of? A clinical trial is the process by which a new drug or medical treatment is tested for safety and efficacy. Generally, trials are divided into Phase 1, 2, 3 and 4.

Phase 1 trials are conducted on healthy individuals and look primarily at safety and how the drug is metabolized in the body. Phase 2 trials are conducted in a small group of individuals and are used both, to learn more about safety and proof of concept and to see if the treatment works in subjects usually with a certain medical condition. Phase 3 trials are larger studies where medications are given to an increased number of individuals typically with a medical condition and typically are used by the FDA to decide on whether to approve a drug or not. Finally, Phase 4 trials are typically used to collect data after a drug is approved and used to answer some safety or efficacy questions at time of the drug approval.

When you inquire about any study that you would like to participate, all the study details will be given to you so you can make an educated decision whether to you want to get enrolled or not. This is usually called Informed Consent, which will be explained in my article for next week. Stay tuned!

-Dr. Howard Schwartz M.D. – Gastroenterologist

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Ancient Science for Modern Health

Mountain Tea

Have you ever wondered whether there might be a higher power out there? No, I am not meaning to engage all of us in a discussion of religion, but rather a discussion about the evolution of nutrition. We are all aware that from the dawn of the human race, food was needed for survival. Without food, there is famine and ultimately no life. So, how did our very ancient forefathers and mothers realize just what to eat versus what not to have? As time and the Earth evolved, so did the advent of religion(s) and thus written dietary laws that helped steer people about foods. The point of this article is focused on what foods, herbals and botanicals ingested as food or drinks were commonly used in ancient times that are worth rediscovering now. Be prepared to learn about a few foods, spices and special beverages that might just be able to do more for you than promote generalized health.

 

  1.      Quinoa – Quinoa (pronounced “keen-wah”) is an ancient grain first brought to nutritional prominence by the ancient Andean population (about 4,000 years ago). This cereal like grain is most popular in Ecuador, Bolivia, Colombia and Peru, with it now becoming a worldwide superstar. Quinoa contains 14% protein (nearly the highest of any cereal-grain), B-vitamins, is high in minerals such as potassium, magnesium and iron, and also is rich in fiber. This is one ancient cereal-grain worth having in your diet. For great quinoa recipes, see http://www.cookinglight.com/food/recipe-finder/cooking-with-quinoa-00412000073996/
  2.      Wheat Berries -A wheat berry is the entire wheat kernel, including the bran, endosperm, and germ, meaning it is a whole grain. The third most abundant crop worldwide, following rice and corn, wheat berries are a great source of healthy carbohydrates. Nutrient count varies depending on the type of wheat berries you select. They can be soft or hard and come in a variety of colors. Overall, wheat berries are high in fiber and protein and contain a variety of nutrients including vitamin E, calcium, B vitamins, folate, and potassium. Eat wheat berries in place of pasta, rice, and other grains, or use them in salads and side dishes. They’re also a great alternative to oatmeal when blended with fresh fruit and nuts. Awesome wheat berry recipes can be found at http://www.eatingwell.com/recipes_menus/recipe_slideshows/easy_wheat_berries_recipes?slide=1#leaderboardad
  3.      Shepherd’s Tea – Shepard’s tea is from ancient Greece. It is also known as Mountain tea, since the magic botanicals that are use to brew it only grow in select mountains above certain altitudes. The botanical name for this tea is Sideritis syriaca.  This tea is a stimulant and it is known to aid the immune system, while also promoting digestion. The tea is now being investigated for it’s anti-inflammatory effects, as well as ability to relieve anxiety. The ancient Greeks were certainly onto something with this tea! Learn about this tea here http://greekfood.about.com/od/mezethesdrinks/a/tsaitouvounou.htm
  4.      Boswellia serrata – Indian frankincense is also known as shallaki. It is found almost only in India. This botanical is considered a staple of Ayurvedic medicine. It has a wealth of naturally occurring pharmaceutically active components. Extracts have been studied for osteoarthritis, joint function, chronic inflammatory diseases (e.g., rheumatoid arthritis, bronchial asthma, osteoarthritis, ulcerative colitis, and so much more. Boswellia seems like a natural alternative to NSAID medications, which is quite safe and growing in popularity. Look for it to be standardized for the boswellic acids content. This botanical is more popular in dietary supplements versus the spice aisle at your local supermarket. No matter where you get your Boswellia, it is just plain good for you.
  5.      Cynomorium Root – this parasitic perennial flower is also known as the Maltese mushroom and the desert thumb.It grows in dry, rocky or sandy soils as well as in salt marshes. This rare flower is found in Europe, Arabia and throughout Asia. It has no chlorophyll and has to be dug out of the ground to be chosen for food. As this flower is pollinated, it has a sweet like odor. Classic ancient medicine used this flower as a sexual tonic, to treat iron losses and in the 9th century it was also used as a salve for skin conditions. This botanical can be eaten as it is “fruit like” or made into standardized extracts. One great resource is http://www.itmonline.org/arts/cynomorium.htm

 

It is my pleasure to share nutritional topics and insights that might be of interest to you and certainly this info is meant to be used for health promotion. Today’s blog was written with the goal of sparking your interest in some nutritional aids that you may not have heard of yet or ever tried. We hope that this information is useful to you – as we know you can apply these tips starting today, for a healthier and more diverse tomorrow.

 

Vida MD – To Your Health!

 

– Douglas Kalman PhD RD FACN.

 

For more great health tips, please follow us on @Miami_Nutrition and also @dougkalmanphdrd

Nutritional Tips for Inner and Outer Beauty

beauty skin

As we grow into adulthood and enjoying what life has to bring, we worry about how we look through this journey. As we learn about our bodies in teenage years, embrace the adventures of our 20’s and grow into our 30’s, what we care about changes. We once felt indestructible, had energy all day and night long, but now we get tired midday. We feel aches and pains we never had before, not to mention the change in our skin. As a health professional, many times I observe friends and colleagues paying more attention to their health only when something is bothering them or a scare hits within their family and close friends. As youths, we often go out in the sun without protecting our skin, and use various techniques to promote faster tanning not realizing that we have increased our chances for premature skin aging and cancer later in life.  This got me thinking about some simple inner and outer health tips that can be adopted at any age for health and wellness promotion.

 

Simple tips:

 

  1.      Hydrate – that is right, water and any non-alcoholic fluid can help you stay hydrated. A dehydrated and even a sub-optimal hydrated body have negative effects on whole body metabolism and the appearance of your skin. Some health professionals believe a goal for daily hydration (from beverages and the fluids found in fruits and vegetables) is equal to half your body weight (but in ounces). For example, if you weigh 100 pounds, your aim is to get 50 ounces of total fluids per day.
  2.      Eat Fish – Fish, such as salmon, mackerel, sardines and certain types of tuna are rich in omega-three fatty acids (omega 3’s). Omega 3 fatty acids play a huge role in the body for heart health (inner beauty) and as an anti-inflammatory (inner and outer beauty). Research has found that those people with low levels of omega 3’s in their diet often have more mood disturbances than those who include omegas in their diet. Great thing is, taking omega 3’s in as little as two-three times per week offers health benefits.
  3.      Enjoy colorful fruits and vegetables – the more colorful a fruit or a vegetable is, the more diverse amount of phytochemicals and nutrients that it contains. Research shows those with a wide variety of colorful fruits and veggies in their diet have lower levels of heart disease and cancer risk (inner beauty). We, in nutrition often ask people to get a total of five to nine servings of fruit and veggies per day. With so many organic and natural juices on the market, there are many ways of getting fruits and veggies in you.
  4.      Don’t skimp on Protein – Protein is so important to the body, in fact, your immune system is based mostly on protein. Protein is the backbone of your immune system and if you are not eating adequate protein, overtime you can get a weaker immune system. Protein is also essential for muscles maintenance and muscle tone, a person with insufficient protein will have weaker and smaller muscles, making daily activities more challenging. Also, your skin contains proteins, which is used for skin elasticity, skin integrity and appearance. Protein aids inner and outer immunity. One way to make sure you are getting enough protein in your diet is to ingest about half your body weight in grams (e.g., weigh 100 pounds, goal is a minimum of 50 grams protein daily).
  5.      Sleep – Of course, Sleep! Getting enough sleep helps our body renew and reduce adding more stress onto your body. Some health promoters say outside of not smoking that getting adequate hydration and rest are two keys to maintaining inner and outer beauty. Everyone is different, and to determine how many hours of sleep you should need is not easy to say. However, we do know those individuals whom get less than four or five hours sleep per night tend to have more illnesses and obesity in their life. Do not underestimate the need for sleep to promote inner and outer beauty!

 

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To your health!

-Douglas Kalman PhD, RD

 

Please follow us too on Twitter – @Miami_Nutrition and on @dougkalmanphdrd

Weight, what does sleep have to do with it, have to do with it?!?!?!?!

 

More than 78 million adults (or 35.7%) and more than 12.5 million children (or 16.9%) in the U.S. are classified as obese. By increasing the risk for cardiovascular diseases, Type 2 diabetes and most cancers, obesity contributes to 1 in 10 deaths, making it the second leading cause of preventable death in the U.S. Obese individuals with diabetes or high blood pressure have a 26% greater risk of death than healthy-weight individuals.

You know that old song, “the thigh bone is connected to the leg bone”. Well, with sleep, “the sleep bone is connected to the weight bone”, so to speak.  Interruptions in sleep may contribute to hormonal changes and fatigue, which may result in less exercise, increased appetite, insulin resistance and diabetes.

Body Mass Index (BMI) is calculated from a person’s weight and height and correlates to measures of body fat. A BMI of greater than 30 is considered obese. Two thirds of people with obstructive sleep apnea (a sleep disorder characterized by loud snoring with repetitive blockage of the upper airway causing arousals from sleep) are obese. Interestingly, neck circumference (your shirt collar size) is associated with obesity and appears to be a risk factor for obstructive sleep apnea (greater than 16 inches for women and greater than 17 inches for men). Losing 10-20% of total body weight can improve the severity of underlying obstructive sleep apnea

Here’s an interesting tidbit. Did you know the timing of food intake, in relation to our internal body clock and the time we sleep, can predict weight gain and weight loss? In an experiment where mice were forced to eat only during the day, the reverse of their normal nighttime eating habits, the mice gained two and a half times more weight, even when their caloric intake remained unchanged. The message to us as humans:  “If you eat earlier and don’t graze with food and snacks after dinner, you’ll be more likely to lose weight”.   Even the timing of when you go to sleep can affect weight. Studies have shown that even changing your sleep schedule on the weekends, the way many of us do by shifting to a later sleep time on a Friday and Saturday night, can contribute to obesity. Not getting enough sleep can contribute to weight gain. A sleepy brain appears to not only respond more strongly to junk food, but also has less ability fight the impulse to eat more, less healthy foods. Remarkable as well is the observation that sleep disturbances in children with sleep apnea my lead to either weight gain or even a “failure to thrive” with actual weight loss.  

Medical research has recently discovered specific hormones which effect weight and appetite. Leptin comes from adipose cells (fat cells) and normally signals satiety = “makes you feel full”.  Ghrelin is another hormone (from the GI digestive tract), which signals increased appetite, tells you to “eat more”.  Stanford University and the University of Wisconsin looked at about 1,000 volunteers who reported the number of hours they slept each night. Doctors then measured their levels of ghrelin and leptin and charted their weight. The result: those who slept less than eight hours a night not only had lower levels of leptin (felt less satiety or less full) withhigher levels of ghrelin (increased appetite), but they also had a higher level of body fat. What’s more, the level of body fat seemed to correlate with their sleep patterns. Specifically, those who slept the fewest hours per night weighed the most.

Parasomnias are sleep disorders defined as “undesirable physical events or experiences occurring during or around sleep”. The typical example is sleepwalking. Well, there exists a phenomenon known as aSleep Related Eating Disorder” characterized by episodes of involuntary eating and drinking during arousals from sleep with no memory of the events.”  We believe this may be a variant of sleep walking and is more common in women than men. It can occur during any time in the sleep cycle with people often eating peculiar forms or combinations of food. The good news is it’s often very treatable.

Dr. Matthew P. Walker, professor of psychology and neuroscience at the University of California, Berkeley seems to have summed it up quite well when he stated,

“It is increasingly clear from the medical literature that there is not a single tissue in the body that is not beneficially affected by improved sleep.  It’s the single most effective thing people can do every day to reset their brain and body health.”

 

-Dr. Timothy L. Grant, M.D., F.A.A.S.M.

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Spirulina: The Superfood

 

spirulina

It’s not easy being green…but if you want to add color to your life some under the sea algae may help. Could we call algae “food”? You bet…and if there is such thing as superfood it can be applied to Spirulina. This algae (cyanbacteria) is incredible high in protein, essential aminoacids and nutrients, rich in Chlorophyll, and known for its high B-12 and iron content.

Does it taste good? On its own probably not unless your taste runs on the fishy side…but think about its great nutrition content. Spirulina has high content of protein and contains all essential amino acids. It is particularly rich in the essential fatty acid gamma linolenic acid (GLA), which has gotten a lot of attention as an anti-inflammatory. Spirulina is rich in Omega-3s and  Chlorophyll, it has a high concentration of bio-available iron.  Spirulina is a great source of vitamins B-1(thiamine), B-2 (riboflavin), B-3 (nicotinamide), B-6 (pyridoxine), B-9 (folic acid), vitamin C, vitamin D, vitamin A and vitamin E. It is also a good source of potassium, calcium, chromium, copper, iron, magnesium, manganese, phosphorus, selenium, sodium and zinc. Spirulina is also very high in calcium even more so than milk.

So go ahead take the green splurge without diving into the ocean and add some Spirulina to your smoothies. Fish should not be the only ones to benefit from its goodness!

 

-Dr. Jackie Miodownik-Aisenberg M.D. PhD – Internist

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What Probiotic should I take?

Couple eating in park

Probiotics are the latest supplement craze and have been widely promoted to improve an individual’s health by improving the bacteria balance in the intestines. Recent studies have found that the body’s immune system interacts with the bacteria that live in the intestine and can produce both positive and negative effects. Probiotics improve the balance of bacteria in the intestine to help a number of symptoms and conditions.

Research is difficult to interpret but there have been studies that showed benefits of probiotics in patients with IBS, Travelers Diarrhea, Antibiotic effects on the GI tract, constipation, Inflammatory Bowel Disease, eczema, and possibly some autoimmune disorders.

But, how does one choose the best probiotic? To make matters worst, there are several different strains of probiotics, each product has different amount of bacteria, and then some need to be refrigerated. In general, it is very difficult to choose.

The most common probiotic strains include Lactobacillis, Bifidobacterium and Sacchromycis, which actually is a fungus. There are few studies comparing different strains of probiotics and therefore it is hard to determine which is best for you.

Second, some probiotics are refrigerated and some are liquid and some are in a pill or capsule form. I recommend taking a Probiotic from a reputable manufacturer whose product has been tested at time of ingestion for viability of the bacteria.

Finally, how many bacteria is ideal in a probiotic is something that is not clear and labels are difficult to read. Many patients think that if 1 billion CFU are good 10 billion CFU are better. This is difficult to determine, as there are few clinical studies performed on this topic.

So, in general I recommend discussing Probiotics with your Physician and taking a single strain product that is not refrigerated from a reputable manufacturer who has done studies to make sure the probiotic is viable when swallowed and can survive the acidic environment in the stomach.

-Dr. Howard Schwartz M.D. – Gastroenterologist

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Have Your Heard the News?

chocolate

Aha! You might be asking what news? The news about the missing Malaysian airliner? The news about Harvard’s basketball team making it past the first round in the NCAA March Madness basketball tournament? No! No I say! Rather, the news, most important news about how chocolate is good for your gastrointestinal system and even for your supporting immune health! For the facts about this most recent chocolate and health study, let’s examine what the researchers from Louisiana State University found.

At the most recent National Meeting of the American Chemical Society, Dr. John Finley and associates presented a most appetizing study. In short, when we eat certain types of chocolate, the bacteria that line the stomach and gastrointestinal system help digest that chocolate and in turn release other compounds that circulate in the body yielding wide array of health benefits.

The bacteria that line the stomach and GI system have their own world and biological functions within all of us “humans”. This system is known as the microbiome. Within the micobiome, the Bifidobacterium and lactic acid bacteria impart positive effects in aiding in food digestion. A side-note here – you might recognize the word or name “bifidobacterium” as this is also a type of probiotic often found in yogurts and specialty dietary supplements.

Both Bifodobacterium and lactic acid helps ferment the compounds within chocolate (polyphenols, for example) and in turn release natural anti-inflammatory compounds to help health throughout the body. No one knows yet if a dark chocolate bar enriched with extra bifidobacterium can replace the trusted Advil® or Naproxen®, however the reality is dark chocolates and probiotics are functional food items/dietary supplements that can yield health benefits.

The food for thought from this first study of interest by Dr. Finley and his group is that dark cocoa might offer health benefits to the body as an anti-inflammatory. These benefits can be extended, if your diet contains a good mix of colorful fruits, vegetables and green tea as these foods also contain healthy polyphenols. Dr. Finley also stated that prebiotics mixed with cocoa (dark chocolate) can potentially improve the body and overall health. One day, we may just see a dark chocolate that contains pro and prebiotics to act as a positive health promoter. Fortunately, if you are interested in being proactive about anti-inflammatory health, you can utilize a pro and prebiotic dietary supplement combined with a small amount of dark chocolate now, and enjoy both the taste and the inner-health benefits.

To learn more health tips, please subscribe to this blog and also follow us on Twitter – at @Miami_Nutrition and @dougkalmanphdrd

To Your Health!

-Doug Kalman PhD, RD

References:

  1. http://www.medicinenet.com/script/main/art.asp?articlekey=177295
  2. http://www.eurekalert.org/pub_releases/2014-03/acs-tpr022414.php

Alpha- Lipoic Acid

Antioxidant Food

Alpha-lipoic acid (ALA) is a man-made version of lipoic acid, a naturally occurring chemical in plants and animals with potent antioxidant properties. It is found in every cell of our bodies, and it helps turn glucose into energy. As an antioxidant, ALA helps fight free radicals. Free radicals are waste products of metabolism that cause harmful chemical reactions that can damage cells in the body. There is evidence that suggests that alpha-lipoic acid may help regenerate other antioxidants and increase their activity. Another characteristic of ALA is that it is both fat- and water-soluble which means it can work throughout the body. Other antioxidants work only in water (like vitamin C) or fatty tissues (like vitamin E).

There is evidence that alpha-lipoic acid can improve the function and conduction of neurons in diabetes. For this reason it has been used for years in Germany to treat peripheral neuropathy, which produces pain, burning, itching, tingling, and numbness in arms and legs as a result of nerve damage. As a dietary supplement, alpha-lipoic acid appears to help increase insulin sensitivity, and may be especially useful in addressing metabolic syndrome.

Dietary sources of ALA include red meat, organ meats (such as liver), and yeast. Also spinach, broccoli, and potatoes are good sources of alpha-lipoic acid. To ensure proper supplementation make sure you buy from reputable source and talk with your doctor about how much alpha-lipoic acid you should take.

-Dr. Jackie Miodownik-Aisenberg M.D. PhD – Internist

For more daily health enhancing tips, please stay plugged into to this blog and follow us on Twitter @Miami_Nutrition