Abstract
An open-label, randomized, exploratory study of 44 healthy overweight subjects with cardio-metabolic syndrome (CMS) risk factors was conducted to assess the safety, tolerability, and efficacy of a proprietary lifestyle modification program without (DIET) and with (PROG) targeted nutraceutical supplementation, including phytosterols, antioxidants, probiotics, fish oil, berberine, and soy, pea, and whey proteins over 13 weeks. Key metrics were recorded at baseline and weeks 9 and 13. For the DIET and PROG groups, compliance was 85% and 86%, respectively, with no adverse events related to the diet or supplements. Twelve subjects discontinued participation before week 9 for reasons unrelated to the study. PROG subjects experienced greater decreases (p < 0.05) than DIET in body mass, fat mass, total cholesterol, LDL cholesterol, TG, cholesterol / HDL ratio, TG/HDL ratio, apolipoprotein B / apolipoprotein A1 ratio, and hs-CRP. The Framingham 10-year cardiovascular disease risk score decreased by 40% (p < 0.01) in the PROG arm versus no change for the DIET arm. As a pilot study, it was not possible to state whether the observed effects were the result of nutraceutical supplementation alone or the result of additive or synergistic interactions among diet, lifestyle modifications, and nutraceutical supplementation. Moreover, individuals with CMS risk factors following a lifestyle modification program received additional health benefits from targeted nutraceutical supplementation.
Highlights
A recent analysis has shown that the number of overweight and obese people worldwide is over 2.1 billion, up from 857 million in 1980, representing a 28% increase among adults and a 47% increase among children.(Wise 2014) Cardio-metabolic syndrome (CMS)1, known as metabolic syndrome, or syndrome X, is a combination of metabolic disorders or risk factors including central obesity, diabetes mellitus, systemic arterial hypertension, and hyperlipidemia.(Kelli et al 2015) According to the NCEP ATP III definition, CMS is present if three or more of the following five criteria are met: waist circumference over 40 inches or 35 inches, blood pressure (BP) over 130/85 mmHg, fasting triglyceride (TG) level over
Noting that the addition of soy protein, phytosterols and selective kinase response modulators to a modified, Mediterranean-style, low glycemic load diet could favorably reduce plasma lipids and CMS risk factors(Lerman et al 2010), we developed a program consisting of a modified Mediterraneanstyle, low glycemic load diet and a broader range of targeted nutraceuticals to address metabolic criteria associated with obesity and CMS
Current treatment guidelines recommend that obese individuals lose 5% to 10% of their starting weights to minimize the risk factors for cardiovascular disease and reduce the risk for developing type 2 diabetes or hypertension.(Wharton 2016) Clinical weight loss in individuals typically stabilizes at 6 months and validated models indicate that weight loss generally plateaus between 1 and 2 years.(Thomas et al 2014) To estimate this plateau and 95% confidence interval for responders in our study, we modeled the cumulative number of responders observed in each arm during the 13 weeks using nonlinear regression (GraphPad Software, San Diego, CA)
Summary
A recent analysis has shown that the number of overweight and obese people worldwide is over 2.1 billion, up from 857 million in 1980, representing a 28% increase among adults and a 47% increase among children.(Wise 2014) Cardio-metabolic syndrome (CMS), known as metabolic syndrome, or syndrome X, is a combination of metabolic disorders or risk factors including central obesity, diabetes mellitus, systemic arterial hypertension, and hyperlipidemia.(Kelli et al 2015) According to the NCEP ATP III definition, CMS is present if three or more of the following five criteria are met: waist circumference over 40 inches (men) or 35 inches (women), blood pressure (BP) over 130/85 mmHg, fasting triglyceride (TG) level over150 mg/dL, fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dL (men) or50 mg/dL (women) and fasting blood glucose over 100 mg/dL.(Huang 2009)While new pharmacological approaches to CMS and type 2 diabetes such as alogliptin, a dipeptidyl peptidase 4 inhibitor, and canagliflozain, a sodium-glucose co-transporter 2 inhibitor, are continually under development(Said et al 2014; Sarnoski-Brocavich and Hilas 2013), the pharmaceutical approach is not suitable or economically sustainable for a pandemic rooted primarily in poor dietary choices and inactivity. Noting that the addition of soy protein, phytosterols and selective kinase response modulators to a modified, Mediterranean-style, low glycemic load diet could favorably reduce plasma lipids and CMS risk factors(Lerman et al 2010), we developed a program consisting of a modified Mediterraneanstyle, low glycemic load diet and a broader range of targeted nutraceuticals to address metabolic criteria associated with obesity and CMS. The objectives of this pilot study were to discern the safety, tolerability and efficacy of a low glycemic-load, modified Mediterranean-style diet and aerobic exercise plan coupled with low-glycemic, protein snack shakes and targeted nutraceutical supplementation on CMS risk factors in generally healthy, overweight people. We hypothesized that all subjects would benefit from the low glycemic-load diet and aerobic exercise plan, but that participants receiving the low-glycemic protein shake and targeted nutraceutical supplementation would have lipoprotein profiles and glycemic control variables associated with a decreased risk for cardiovascular disease
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
