Evidence-Based Clinical Trial Design for Weight Loss with Dietary Supplements

Category: Healthcare Advances Written by Dr. Charles Shively / August 13, 2018

During the past fifteen years the evolution of clinical trial activities for weight loss associated with dietary supplement use has expanded and become more definitive. Previous clinical trials often used extensive and intricate analysis of the effects of apparent metabolic disorder as impacted by different meal replacement adjustments through available and readily assessable variables or endpoints. Today the clinical trials being conducted include controlled environment conditions for the study participants with data collection involving various specific metabolic variables and the impact of individual microbiome on metabolism and metabolic syndrome control. Ten landmark studies are reviewed to showcase the emergence of evidence-based clinical trial design and resultant outcomes.

Which comes first? Weight loss or glucometabolic regulation? Glucometabolic regulation is the catalyst which can adjust or impart alterations in the

body’s metabolism which involves insulin resistance, glucose and lipid metabolism and increased blood pressure associated with obesity. Glucometabolic regulation can effect weight loss.

One of the first studies in this arena (2004) came from the Department of Rehabilitation and Preventive Sports Medicine at the University Hospital in Freiburg, Germany in collaboration with the Institute of Immunology at the University Willet/Herdecke, in Wittet, Germany.  This key study was designed to determine change of weight, body composition, and various metabolic and hormonal parameter changes induced by different intervention protocols in both men and women. The initial study with 90 healthy subjects selected from over 500 applicants was conducted over six months and evaluated various biochemical parameters for three different intervention approaches: lifestyle education, a substituted plant-derived meal replacement and a combination substituted plant -derived diet with physical activity group. The biochemical properties(variables) evaluated included total cholesterol, HDL-cholesterol, LDL-cholesterol, APO-B, Leptin, Insulin and Glucose. The results of this study set the course for many subsequent studies in various centers as the use of plant-derived proteins was shown to eliminate the disadvantages of animal based products which have been associated with saturated fatty acids and cardiovascular disease. This study in pre-obese and obese subjects evaluating weight loss using a high soy protein diet demonstrated that a high soy protein and low fat diet can improve the body composition in overweight and obese people through the loss of fat while preserving muscle mass. (1)

A followup study was conducted to examine the effect of weight loss intervention on anthropometric measures and metabolic risk factors in pre- versus postmenopausal women. Comparable weight loss was demonstrated in both groups yet postmenopausal women weight loss was associated with a pronounced improvement in metabolic risk factors reducing the prevalence of metabolic syndrome as defined by NCEP (National Cholesterol Education Program) criteria. The importance of the hormone leptin and its impact on metabolic syndrome began to surface in studies of this type for weight loss and diet adjustment. (2)

As research continued during the late 2000’s (3) and into the early 2010’s , the prominence of how plant-based product meal replacements (with isofavone soy) that included high amounts of essential and branched-chain amino acids (yielding probiotic peptides) was shown to impact glycemic control and impact not only fat mass but fat free mass. Continued lowered metabolic risk factors such as reduced insulin requirements, HbA1c and weight long term in type diabetic patients with >100 units of insulin per day was demonstrated. Although this study published by British Dietetic Association in 2013 included only a 12 week program initially with 15 participants, these participants were compliant with the prescribed regimen which involved a meal replacement (MR) Phase I approach of three meals of 50 gram of a protein meal replacement (PRMR) for one week followed by a Phase 2 during weeks 2-4 where breakfast and dinner were replaced and in weeks 5-12 only dinner was replaced. Clinical parameters were determined at baseline and after 4, 8 and 12 weeks as well as after 1.5 years of follow-up. After 1.5 years, insulin requirement and weight remained significantly lower than baseline. This demonstrated conclusive evidence that HbA1c values and cardiometabolic risk factors are adjusted with plant-based soy product meal replacements. Interestingly in this study, two patients were able to stop insulin therapy altogether. (4)

A Quality of Life study published in the journal BMC Women’s Health (2014) evaluated the lower health-related quality of life (HRQOL) that severe obese people may experience and the value of soy-based meal replacement in obese middle-aged women with evaluations using the SF-36 questionnaire (a 36 item assessment of health status). Statistically significant improvement was demonstrated in physical function, body pain, general health, social function and mental health in contrast to those individuals who had no meal plant based soy meal replacement. (5).

In individuals with metabolic syndrome, intra-abdominal fat stores and various cardiometabolic risk factors have been determined using MRI (Magnetic Resonance Imaging) (6). The value of a high soy-protein drink with low glycemic index in pre-diabetic healthy individuals to reduce development of type 2 diabetes mellitus was demonstrated. (7) A perhaps landmark clinical study evaluated the role of serum leptin levels in the prediction of weight loss and weight-loss maintenance. Leptin, as a circulating adipokine, is a regulatory factor for food intake, energy expenditure and body fat distribution. It is also involved as part of the signaling system that regulates the amount of adipose energy stored in the brain. This study of 90 middle-aged healthy non-smoking adult men and women compared therapeutic lifestyle changes with a standardized soy-based meal replacement and a standardized soy-based meal replacement with supervised exercise/physical training. Both groups which included the soy-based meal replacement had significant changes in metabolic and inflammatory markers (compared to baseline). The positive effect on inflammatory markers would appear to be the result of the low glycemic and glycemic load found in the soy-based meal replacement. It contains no sugar which can be a source of chronic inflammation. (8)

A unique study involving the West-German Centre of Diabetes and Health (Dusseldorf) and the German Institute for Telemedicine and Health Promotion (Dusseldorf) evaluated the efficacy of a telemedical lifestyle intervention program in improving metabolic control (HbA1c) in advanced-stage type 2 diabetes. This physician-controlled study with 100 patients as a control group and 100 patients in the telemedical lifestyle intervention program (using a plant based soy protein meal replacement) had as a primary end point the treatment difference in HbA1c reduction after 12 weeks. There was continued followup at 26 and 52 weeks. The group using the plant based soy product had improved glycemic control, reduced insulin demand, reduction of hunger, weight reduction, reduced systolic blood pressure and reduced BMI (body mass index). (9)

Perhaps the most advanced metabolic and microbiome studies are currently being conducted today at the University of Alberta Center for Health Research Innovation Human Nutrition Research Unit. The metabolic study portion of this unique clinical effort is a randomized, controlled, cross-over trial investigating the impact of a high-protein diet on substrate oxidation and energy metabolism in healthy women. This study is being conducted using a state-of-the art live-in whole body calorimetry unit (WBCU).  Analysis of the macronutrients (to date) which are being metabolized (Respiratory Quotient-RQ) has indicated that more lipids are being metabolized and more kilocalories are burned when a plant-based soy protein product (Almased) is consumed. This metabolic study is confirming that metabolism is being accelerated and increased fat oxidation provides a lower RQ while increasing total energy expenditure. The effect of Almased as a meal replacement is immediate. (10)

As evidence-based studies on the weight loss associated with use of plant-based dietary supplements continue to be investigated, more recent studies implemented in 2017 at various international centers report that results forthcoming in early 2019 clearly demonstrate that one plant-based soy protein meal replacement (Almased) does indeed impact metabolic syndrome markers and the known metabolic endotoxemia link between gut problems and chronic disease. Indeed, evidence-based studies are defining the necessary sophistication of clinical study design to ensure truthful knowledge about which comes first: Glucometabolic regulation or weight loss.

In summary, global clinical trials are advancing the science about issues with weight loss based upon evidence-based clinical trials which offer understanding about the complexities of metabolic syndrome.  For more information visit www.almased.de, www.almased.com or www.almased.co.uk.







Thank for sharing!

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