Tag Archives: supplements

Banned Stimulants Remain in Supplements, Despite FDA Efforts to Remove Them

Posted on by
Reply

MedicalResearch.com Interview with:

Pieter Cohen, M.D. Associate Professor of Medicine Cambridge Health Alliance Assistant Professor of Medicine Harvard Medical School

Dr. Cohen

Pieter Cohen, M.D
Associate Professor of Medicine
Department of Medicine
Cambridge Health Alliance
Somerville MA 02143

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Since ephedra was banned from supplements in 2004, a variety of experimental stimulants have been introduced into sports and weight loss supplements as ephedra replacements.  The FDA has made some efforts to remove these emerging stimulants from supplements, but whether FDA action to remove these stimulants has it’s intended effect is not known.

We studied the effect of FDA action to remove four experimental stimulants from supplements.

We found that the FDA public notices did not work.  The stimulants remained in supplements even years after the FDA moved to remove them.

MedicalResearch.com: What should readers take away from your report?

Response: Given the regulatory paradigm under which supplements are sold, consumers cannot trust that they will be effective or safe.  Clinicians should understand that supplements might contain hidden ingredients that have potent drug-like effects and consider the effects of supplements when patients experience unexplained symptoms.

MedicalResearch.com: What recommendations do you have for future research as a result of this work? 

Response: One of the most concerning findings was that one stimulant appeared in the supplements analyzed only after the FDA warned that it was not permitted to be sold in supplements. Future studies should investigate whether FDA announcements regarding new experimental stimulants might have the unintended consequence of firms learning about the stimulant and then adding it to their supplements.

Disclosures: Dr Cohen was subject of a civil suit brought by Hi-Tech Pharmaceuticals, a supplement company, regarding β-methylphenylethylamine;  The jury found in Dr Cohen’s favor. Dr Cohen has collaborated in research with NSF International and received research support from Consumers Union. No other disclosures were reported.

Citation:

Cohen PA, Wen A, Gerona R. Prohibited Stimulants in Dietary Supplements After Enforcement Action by the US Food and Drug Administration. JAMA Intern Med. Published online October 22, 2018. doi:10.1001/jamainternmed.2018.4846

Oct 23, 2018 @ 2:33 pm

 

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

 

Omega-3 Fatty Acids May Reduce Anxiety

Posted on by
Reply

MedicalResearch.com Interview with:
“omega 3” by Khaldaa Photographer is licensed under CC BY 2.0Yutaka MATSUOKA, MD, PhD
Division Chief of Health Care Research,
Behavioral Sciences and Survivorship Research Group,
Center for Public Health Sciences,
National Cancer Center Japan

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Anxiety is the most commonly experienced psychiatric symptom. We have now two major treatment options that include cognitive-behavioral therapy (CBT) and pharmacotherapy.  However, CBT is time-consuming, costly, and limited in availability. And there is concern over potential side effects in pharmacotherapy. Evidence-based and safer treatment options are required. Omega-3 fatty acids have potential preventive and therapeutic effects on depression and anxiety. Clinical and preclinical studies support the effectiveness of omega-3 fatty acids as a treatment for anxiety disorders. Despite the largely positive findings of these trials, the clinical application of the findings is unfortunately limited by their small sample size.

Improvement in anxiety symptoms were associated with omega-3 fatty acids treatment compared with controls. The anxiolytic effects of omega-3 fatty acids were also stronger in patients with clinical conditions than in subclinical populations.  Continue reading →

Cardiac Stimulant Found in Some OTC Supplements

Posted on by
Reply

MedicalResearch.com Interview with:

Pieter Cohen, M.D. Associate Professor of Medicine Cambridge Health Alliance Assistant Professor of Medicine Harvard Medical School

Dr. Cohen

Pieter Cohen, M.D.
Associate Professor of Medicine
Cambridge Health Alliance
Assistant Professor of Medicine
Harvard Medical School

MedicalResearch.com: What is the background for this study?

Response: Dietary supplements lead to an estimated 23,000 emergency department visits each year in the United States (US), and weight loss and sports supplements contribute to a disproportionately large number of these emergency department visits. It is not known which ingredients in weight loss and sports supplements pose the greatest risk to consumers, but there are stimulants found in botanical remedies that might pose risks.

In the current study, we investigated the presence and quantity of higenamine a stimulant found in botanicals and available in sports and weight loss supplements sold in the US.

Continue reading →

Could Some Iron Supplements Raise Your Risk of Colon Cancer?

Posted on by
Reply

MedicalResearch.com Interview with:

Nathalie Scheers PhD Asst. Professor Chalmers University of Technology Dept of Biology and Biological Engineering Food and Nutrition Science Göteborg, Sweden 

Dr. Scheers

Nathalie Scheers PhD
Asst. Professor
Chalmers University of Technology
Dept of Biology and Biological Engineering
Food and Nutrition Science
Göteborg, Sweden 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Many different forms of iron supplements are used to treat iron deficiency symptoms or as phosphate binders in patients with renal disease. two of these iron supplements, the chelates ferric citrate and ferric EDTA have been observed to drive colon cancer in mice. In the newly published study in Oncotarget, we are reporting our work on how these iron compounds differ compared to the simple salt ferrous sulphate, which is another common iron supplement.

The main finding of this study was that ferric citrate and ferric EDTA promoted the cancer biomarker amphiregulin which in turn activated the MAP kinase ERK in gut epithelial cancer cells. There were no such effects in ferrous sulphate-treated cells.  Continue reading →

Review Finds Antioxidant Supplements of Little to No Benefit in Exercise Recovery

Posted on by
Reply

MedicalResearch.com Interview with:
“Pills Vitamins Macro April 22, 2012 4” by Steven Depolo is licensed under CC BY 2.0Dr Mayur Ranchordas, SFHEA
Senior Lecturer in Sport Nutrition and Exercise Metabolism
Sport Nutrition Consultant
Chair of the Sport and Exercise Research Ethics Group
Sheffield Hallam University
Academy of Sport and Physical Activity
Faculty of Health and Wellbeing
Sheffield

MedicalResearch.com: What is the background for this study? 

Response: People engaging in intense exercise often take antioxidant supplements, such as vitamin C and/or E or antioxidant-enriched foods, before and after exercise in the anticipation that these will help reduce muscle soreness. In a new review published in the Cochrane Library we looked at the evidence from 50 studies. These all compared high-dose antioxidant supplementation with a placebo and their participants all engaged in strenuous exercise that was sufficient to cause muscle soreness. Of the 1089 participants included in the review, nearly nine out of ten of these were male and most participants were recreationally active or moderately trained.

Continue reading →

Prebiotin™ Fiber Supplement Tested in NIH/NIDDK Pilot Study In End-Stage Kidney Disease Patients

Posted on by
1

MedicalResearch.com Interview with:

Ron Walborn Jr. Prebiotin CEO

Ron Walborn Jr.

Ron Walborn Jr.
Prebiotin CEO 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The product Prebiotin™ Prebiotic Fiber was brought to market in 2007 by Dr. Frank Jackson, a gastroenterologist out of Harrisburg, PA. He found through 40 years of experience with his patients that a variety of digestive issues benefitted from daily supplementation with a soluble prebiotic fiber, specifically, oligofructose-enriched inulin (OEI) derived from chicory root.

In the late summer of 2012, Prebiotin caught the attention of Dr. Dominic Raj at the Internal Medicine Department of George Washington University. Dr. Raj’s laboratory showed that patients with kidney disease may have a higher level of release of endotoxins like p-Cresol sulfate and indole from the bacteria in the gut, which can move into the bloodstream and promote inflammation.

This early work was the basis of a successful grant application. Researchers were interested in investigating the therapeutic potential of altering the composition and/or function of the gut microbiome in this patient population, based on the understanding that by building up the levels of healthy bacteria in the gut, undesirable bacteria is eventually crowded out, thereby reducing the release of harmful endotoxins into the system.

Continue reading →

Neither Vitamin E or Selenium Found To Prevent Dementia

Posted on by
Reply

MedicalResearch.com Interview with:

Richard J. Kryscio, Ph.D. Statistics and Chair, Biostatistics and Sanders-Brown Center on Aging Sanders-Brown Center on Aging University of Kentucky

Dr. Richard Kryscio

Richard J. Kryscio, Ph.D.
Statistics and Chair, Biostatistics and Sanders-Brown Center on Aging
Sanders-Brown Center on Aging
University of Kentucky 

MedicalResearch.com: What is the background for this study?

Response: At the time the trial was initiated (2002), there was ample evidence that oxidative stress is an important mechanism in brain aging. Research showed that protein oxidation is linked to the brain’s response to the abnormal proteins seen in Alzheimer disease (amyloid beta plaques in particular) leading to inflammation, DNA repair problems, reduced energy production, and other cellular changes that are identified mechanisms in the Alzheimer brain.

Both vitamin E and selenium are antioxidants. Antioxidants, either through food or supplements, are believed to reduce oxidative stress throughout the body. In the brain, they may reduce the formation of amyloid beta plaques, reduce brain inflammation, and improve other brain processes. Studies in humans support these hypotheses. The Rotterdam study in the Netherlands, as an example, showed that initial blood levels of vitamin E could predict dementia risk. Those people with higher vitamin E levels were 25% less likely to develop dementia. Also, selenium deficiency results in cognitive difficulties and several population-based studies have shown an association between selenium level and cognitive decline (lower selenium levels are linked to thinking changes in the elderly).
Continue reading →

Use of Health Supplements Varies By Age Group

Posted on by
Reply

MedicalResearch.com Interview with:

Elizabeth D. Kantor, PhD MPH Department of Epidemiology and Biostatistics Memorial Sloan Kettering Cancer Center NY, NY

Dr. Elizabeth D. Kantor

Elizabeth D. Kantor, PhD MPH
Department of Epidemiology and Biostatistics
Memorial Sloan Kettering Cancer Center
NY, NY

MedicalResearch.com: What is the background for this study?

Response: Prior studies show that use of supplements increased between the 1980s and mid-2000s, and despite much research conducted on the health effects of supplements, we know little about recent trends in use.

Given this gap, we decided to create an up-to-date, comprehensive resource on the prevalence and trends of supplement use among US adults using nationally representative data from the National Health and Nutrition Examination Survey (NHANES). Data were collected over seven continuous cycles (from 1999-2000 to 2011-2012).

Continue reading →

Dietary Supplements Are A $36 Billion Business

Posted on by
3

MedicalResearch.com Interview with:

Leigh Purvis, MPA Director of Health Services Research AARP Public Policy Institute

Ms. Leigh Purvis

Leigh Purvis, MPA
Director of Health Services Research
AARP Public Policy Institute

Editors’ note: In conjunction with the AARP’s new investigative piece, ‘Supplement Pills That Promise Too Much’, Leigh Purvis, Director of the AARP Health Services Research program discussed the issue of the proliferation of supplements, often with labels that make extraordinary health benefit claims.

MedicalResearch.com: How many Americans use nutritional supplements? How big is the business of supplements?

Response: Supplements are very popular in the United States. This is particularly true for older adults. A recent study found that the proportion of older adults using supplements increased from 52 percent in 2005 to 64 percent in 2011, and the share using multiple supplements grew by nearly 50 percent.

According to the National Institutes of Health, American spent an estimated $36.7 billion on dietary supplements in 2014.

Continue reading →

Complex Dietary Supplement Abolishes Brain Cell Loss in Mice

Posted on by
Reply

MedicalResearch.com Interview with:

Jennifer Lemon, PhD Research Associate Medical Radiation Sciences McMaster University

Dr. Jennifer Lemon

Jennifer Lemon, PhD
Research Associate
Medical Radiation Sciences
McMaster University

MedicalResearch.com: What is the background for this study?

Dr. Lemon: Research with the supplement began in 2000, as part of my doctoral degree; we developed the supplement to try to offset the severe cognitive deterioration and accelerated aging in a mouse model we were working with in the lab. Based on aging research, five mechanisms appeared to be key contributors to the process of aging; those include oxidative stress, inflammation, mitochondrial deterioration, membrane dysfunction and impaired glucose metabolism. The criteria we used for including components in the supplement were as follows: each one of the 30 components had scientific evidence to show they acted on one or more of the above mechanisms were able to be taken orally, and were available to humans over-the-counter. Even then the hope was that if the formulation was successful, this would make it more available to the general public.

Continue reading →

Many Patients Do Not Tell Their Primary Care Physician About Alternative Medicine Use

Posted on by
1

MedicalResearch.com Interview with:

Judy Jou, MA PhD Candidate PhD Candidate in Health Services Research, Policy, & Administration Division of Health Policy and Management University of Minnesota, Twin Cities Minneapolis, MN

Judy Jou

Judy Jou, MA PhD Candidate
PhD Candidate in Health Services Research, Policy, & Administration
Division of Health Policy and Management
University of Minnesota, Twin Cities
Minneapolis, MN 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  Use of complementary and alternative medicine (CAM) is rising among U.S. adults, but CAM is often poorly integrated into patients’ treatment and self-care routines. We analyzed nearly 7,500 responses from the 2012 National Health Interview Survey (NHIS) and found that over two-fifths of U.S. adults who used CAM during the past year did not disclose their complementary and alternative medicine use to their primary health care providers, with rates of disclosure varying by the type of CAM used. We also examined reasons for non-disclosure and found that, in contrast to prior studies, lack of provider-initiated conversation about  complementary and alternative medicine was the most commonly cited reason, rather than patients’ concerns about negative reactions from their providers regarding their complementary and alternative medicine use.

Continue reading →

Calcium Supplements Linked To Increased Risk of Kidney Stones

Posted on by
Reply

MedicalResearch.com Interview with:
Christopher Loftus M.D. candidate
Cleveland Clinic Lerner College of Medicine

Medical Research: What is the background for this study? What are the main findings?

Response: Most kidney stones are made, at least partially, of calcium composite. In a prospective study of nurses in the post-menopausal age, it was found that diets that contained high amounts of calcium were beneficial in preventing kidney stones in this population. In the gut, calcium can bind to oxalate which prevents it from being absorbed into the body and decreases the concentration of calcium in the urine. However there has been debate as to whether supplemental calcium (calcium pills) has the same beneficial effects as calcium in the diet. Supplemental calcium enters the gut in large quantities all at once so it may enter the blood stream in higher concentrations over smaller amounts of time. By the same token, vitamin D plays a role in the management and balance of calcium in the body and could potentially have an effect on stone formation as well.  It has also been debated whether vitamin D supplementation has major effect on patients who are known to be stone formers.  So we reviewed CT scans of patients and 24 hour urine collections (both male and female of adult age) who were known to have kidney stones and measured the growth of stones over a period of time.

Our main findings were that supplementary calcium increased the rate of stone formation in these patients. We also found that vitamin D had a protective effect and patients taking only vitamin D had a slower rate of stone progression.

Continue reading →

Creatine Supplement Increased Muscle Mass But Not Strength or Function in RA Patients

Posted on by
Reply

Prof. Andrew B Lemmey School of Sport, Health and Exercise Sciences Bangor University Bangor, Gwynedd, Wales, UKMedicalResearch.com Interview with:
Prof. Andrew B Lemmey
School of Sport, Health and Exercise Sciences
Bangor University
Bangor, Gwynedd, Wales, UK

Medical Research: What is the background for this study?

Prof. Lemmey: Substantial loss of lean mass (LM; mostly skeletal muscle) is common in patients with rheumatoid arthritis (RA), as we and others have shown that even amongst patients with well-controlled disease approximately 67% are significantly muscle wasted. This loss of muscle, termed “rheumatoid cachexia”, is a major contributor to the decreased strength and impaired physical function which continues to characterise RA. Unfortunately, current drug treatments for RA, including use of biologics and the ‘treat-to-target (T2T)’ strategy, do not reverse this LM loss, nor fully restore physical function (Lemmey et al., “Tight control of disease activity fails to improve body composition or physical function in rheumatoid arthritis patients”. Submitted to Rheumatology (Oxford), currently under review). Whilst high-intensity exercise (specifically, progressive resistance training (PRT)) has been shown to be highly effective in restoring both  lean mass and function in  rheumatoid arthritis patients (Lemmey et al., Arthritis Care & Research 2009;61(12):1726-34), the lack of uptake and adherence to sufficiently intense training (Lemmey et al., Arthritis Care & Research 2012;64(1):71-5) means this form of therapy is not widely adopted. Anabolic nutritional supplementation offers a potential adjunct treatment intervention for increasing LM, and thereby improving physical function, that could be widely accepted. Indeed, our group (Marcora et al., Clinical Nutrition 2005;24(3):442-54) has previously demonstrated that 12 weeks of daily oral protein supplementation improved lean mass and some measures of strength and function in  rheumatoid arthritis patients.

Creatine (Cr) is a popular dietary supplement generally shown to have greater benefits on both lean mass and physical function than generic protein supplementation. One study (Willer et al., Rheumatology 2000;39(3):293-8) has investigated the efficacy of Cr supplementation in rheumatoid arthritis patients. In this short uncontrolled trial, twelve patients underwent 3 weeks of supplementation, and although strength increased, no changes in function were found, and body composition changes were not investigated.

Using a double-blind, placebo controlled design, the current study aimed to investigate the effects of 12 weeks of oral Cr supplementation on body composition (by DXA; dual energy X-ray absorptiometry), strength (knee-extensor and handgrip) and objectively-assessed physical function (chair and walk tests) in patients with RA. Thirty-five patients (Cr=15, Pl=20) completed the study.  Continue reading →

Phytochemical May Prevent Liver Damage In Post Menopause Women

Posted on by

Colette Nicole Miller FDN Department of Foods and Nutrition Edgar L. Rhodes Center for Animal and Dairy Science University of Georgia, Athens, GeorgiaMedicalResearch.com Interview with:
Colette Nicole Miller FDN
Department of Foods and Nutrition
Edgar L. Rhodes Center for Animal and Dairy Science
University of Georgia, Athens, Georgia

Medical Research: What is the background for this study?

Response: Our laboratory has been interested for quite some time in the relationship that natural, plant-derived compounds have on various tissues in the body. Both bone and adipocytes are derived from the same progenitor cell, mesenchymal stem cells. Thus, if a drug or compound affects one type of cell, it may affect both. When women transition through menopause, and see a reduction in their female sex hormones like estrogen, they can see adverse changes in both how much fat they store and their bone density. Thus our lab is interested in compounds that can be used to prevent the bone loss and visceral adipogenesis that menopausal women often experience. Previous work both in vivo and in vitro has shown that phytochemicals have synergistic effects and thus can ultimately work together to reduce the dosages needed to promote overall health. Through this work we have identified a combination of genistein, resveratrol, quercetin and Vitamin D that improve bone density in addition to promoting apoptosis of adipocytes. However, the health of the liver had never been addressed with our phytochemical blend. We know that supplements are sometimes toxic to the liver for many different reasons. Thus, it was very important for us to address the toxicity and potential risk of non-alcoholic fatty liver disease with our phytochemical blend in a menopausal rat model.

Continue reading →

St. John’s Wort May Cause Dangerous Drug Interactions

Posted on by

MedicalResearch.com Interview with:
Scott A. Davis, MA
Research Administrative Coordinator
Department of Dermatology
Wake Forest School of Medicine

MedicalResearch: What are the main findings of the study?

Answer: St. John’s wort (SJW), a common complementary and alternative medicine (CAM) treatment for depression, is frequently used together with drugs that may interact dangerously with it. In data from the 1993-2010 National Ambulatory Medical Care Survey, a nationally representative survey of physician visits from the National Center for Health Statistics, SJW was prescribed together with drugs such as selective serotonin reuptake inhibitors (SSRIs), benzodiazepines, warfarin, statins, digoxin, verapamil, and oral contraceptives. Using SJW together with other antidepressants may cause serotonin syndrome, a potentially fatal condition.
Continue reading →

Study Cautions Against Resveratrol Supplements During Pregnancy

Posted on by

Antonio E. Frias, MD Associate Professor | Division of Maternal Fetal Medicine Oregon Health & Science University Director, Diabetes and Pregnancy Program Assistant Scientist | Oregon National Primate Research Center Portland, Oregon 97239MedicalResearch.com Interview with:
Antonio E. Frias, MD
Associate Professor | Division of Maternal Fetal Medicine
Oregon Health & Science University
Director, Diabetes and Pregnancy Program
Assistant Scientist | Oregon National Primate Research Center
Portland, Oregon 97239

MedicalResearch: What are the main findings of the study?

Dr. Frias: Resveratrol supplementation in pregnant nonhuman primates fed a Western-style diet improved maternal metabolism, restored placental blood flow, reduced placental inflammation and improved lipid deposition in the fetal liver.  However, there was an unexpected disruption of fetal pancreatic development that is very concerning.
Continue reading →