How can I make sure to receive study drug in a research trial and why does the study have placebos?

Medication Trial

Most Clinical Trials are “double blind”meaning that neither the patient nor the medical team know what medication or dose they are receiving until the study is over. Occasionally studies are “open label” where everyone knows what treatment the patient is getting. Less frequently studies can be single ” single blind” where one of the parties is aware of the treatment and the other is not.

In addition most trials involve a placebo which is a tablet that looks like the test medication but has no active ingredients. These trials compare the safety and efficacy of a new medication to a placebo or no treatment. This  can pose an ethical dilemma when a trial is evaluating a medical condition that has good medical options, hence participating in a trial may result in the individual not being treated for their medical issue

Occasionally trials use a comparator drug or different doses of the study drug  however the most effective way to test the efficacy and safety of a product is in a placebo controlled  double blind trial which  is ” the gold standard” .

I tell my patients that enrolling in a trial is important to help bring new safe treatment options to the market and does not always benefit those participating. Communication between the study team and study participant is crucial for a study to be successful.

-Dr. Howard Schwartz M.D. – Gastroenterologist

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Three Tips to Avoid Binging

Wine Glass

Every now and then do you enjoy a glass of wine with your dinner? Or perhaps, do you and your significant other sit, open a bottle of wine, enjoy some food and relax with each other? All of these aforementioned things can be fine and healthy and certainly are commonplace in adult society. So, should one worry if you like to include wine in your lifestyle?

 

Experts say that when it comes to food, to eat all things in moderation. However, how many moderates do you really know? Look around you with two-thirds of American society either overweight or obese, clearly the word moderation is not well understood. Yes, one can argue that weight status has nothing to do with enjoying the seasonal varietal, however such an argument might be short sighted. Weight status is related to how many calories we eat (consume) and how much we burn throughout the day and more importantly, over time. Can a single night of having perhaps instead of one glass of wine, but now three negatively affect you?

 

A new research study has found that having three glasses of wine can alter brain chemistry and decision making over the next 24-hours. In this study survey of over 2,000 adults, more than 50% said whenever they had three glasses of wine or more, within the next day, found themselves binging on food. The binge resulted in anywhere from 2,000 to 6,000 calories being eaten within the 24-hour period. As you might guess, the majority of people in this study also did not exercise the day after they binged (meaning the day after just having three glasses of wine).

 

So if you know that you might be having more than three glasses of wine and do not want to suffer all of the consequences possible from this, what might you do?

 

  1. Do not drink on an empty stomach. Make sure to eat food throughout the day and of course, to keep it low sodium. Extra salt makes you thirstier, salting foods is a great bartenders trick to make you buy more drinks.
  2. For every glass of wine ingested, drink an equal amount of water. Have an extra glass of water before going to sleep. This can help offset the diuretic effects of alcohol and prepare your body for a healthy tomorrow.
  3. The next day, when you awake, have a big glass of water, stretch and have a healthy breakfast. Within an hour, go for exercise or at least a long walk of at least 45 minutes. This helps to maintain a great metabolism and promotes healthier digestion. In addition, the exercise and healthy eating helps set your brain for a great day.

 

No one purposely wants to overeat when knowing that they can end up overweight and unhealthy. Drinking three or more glasses of wine can affect thinking and other mental processes. Being aware of this when just enjoying a bottle of wine with a friend or a mate can help you prepare for success the next day versus overeating or binging on extra food. These three little steps can help protect you from unwanted next day and longer effects of a nice evening.

 

To Your Health!

– Douglas S. Kalman PhD RD

 

For more great health and lifestyle tips, please follow me on Twitter:

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@dougkalmanphdrd

 

Reference

 

1. http://www.bbc.com/news/health-27124357

Is it safe to participate in a clinical trial?  

Clinical Study

In general all research studies are designed to minimize the risk to the volunteers participating in the clinical trial. Most drug studies start evaluating the safety of the drug at the lowest dose and only move onto higher doses once a lower dose is found to be safe. During the trial, medical exams, office visits, laboratory and diagnostic test are unitized to monitor individuals safety and wellbeing while they are in a clinical trial.

It is important that you see your study doctor at every trial visit and let them know if you are experiencing any side effects from the investigational treatment. In my opinion, there are risks to any new treatment; however, if you have an informed volunteer with an experienced physician and a trial team, the study process works and the benefits out way the risks for most study participants.

Remember, as a study participant you can withdrawal or discontinue your study participation at any time for any reason without penalty or prejudice.

Thank you for following this series of articles. My goal is for you to be informed and have more knowledge about clinical trials. Don’t miss next week topic on study drug versus placebo.

 

-Dr. Howard Schwartz M.D. – Gastroenterologist

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Five Ways to Burn Extra Calories Without Trying

weight loss

Achieving and maintaining weight loss is not always so easy. Foods, snacks, beverages and more are constantly being advertised. It might now be more of a rarity to drive and not see a fast food restaurant and yet other places that sell or retail foods and beverages. Technology has opened up new ways of working and living to help us be more efficient with our time. One end result of these improvements is we are less active in general than in years past. Frustrations with weight can also result. Thinking about nutrition or health interventions that may be helpful, I examined the most current medical and scientific research as published by the National Library of Medicine. The tips are summarized below.

  1. 36,500 extra calories burned, just like that! One recent study found that by drinking extra tea one may burn about up to an extra 100 calories per day. Try drinking five cups of either green or oolong tea in order to enjoy this benefit (1,2).
  2. Might there be a treatment for cellulite? The answer is yes! In fact, it appears that Johnson & Johnson has a formula in mind, from what they recently tested in France, described as “topical cosmetic slimming product combining tetrahydroxypropyl ethylenediamine, caffeine, carnitine, forskolin and retinol.” (3) Read your favorite product labels, if you see these ingredients, chances are, you have the product that was effective in the referenced study.
  3. Berberine, an alkaloid found in Traditional Chinese Medicine (TCM) has weight loss effects while also supporting healthy cholesterol (lipid) levels. (4)
  4. A new B-like vitamin positively influences energy metabolism and reduces inflammation. This vitamin is known as PQQ. Research dosage found to be beneficial in humans was about 20 mg (5).
  5. Whey for weight loss? Whey protein combined with glucomannan fiber aids in feelings of satiety. In fact, the reduction in want to eat correlated with hormonal indicators of the same. The dose needed of both ingredients was small, 8 grams whey plus 1-gram glucomannan (6). This is easy to find in the health food store or online.

Today’s blog goal was to share evidence-based, referenced modern scientific solutions to help you obtain your goals. The evidence shared on this blog is meant to be used as simple tips that may help you in weight loss support. Nutrition is an evolutionary science, we are always learning more. Hopefully this blog serves you well in helping you to achieve your health and fitness goals.

 

To Your Health!

 

– Douglas S. Kalman PhD RD

 

 

For more great health and lifestyle tips, please follow me on Twitter:

@Miami_Nutrition

@dougkalmanphdrd

 

References:

 

  1. http://www.ncbi.nlm.nih.gov/pubmed/?term=oolong+tea+and+thermogenesis
  2. http://www.ncbi.nlm.nih.gov/pubmed/20156466
  3. http://www.ncbi.nlm.nih.gov/pubmed/21564138
  4. http://www.ncbi.nlm.nih.gov/pubmed/22739410
  5. http://www.ncbi.nlm.nih.gov/pubmed/24231099
  6. http://www.ncbi.nlm.nih.gov/pubmed/24319546

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