Safety Evaluation of a Lifestyle Modification Program In.Form 1.1
Safety Evaluation of a Lifestyle Modification Program In.Form 1.1
The study evaluated and compared the safety, tolerance and acceptability of a lifestyle
 modification program with or without nutritional supplementation in generally healthy
 overweight subjects with cardiometabolic risk factors.
To investigate the safety, tolerance and acceptability of a low-glycemic load diet combined
 with exercise and lifestyle modification education (DIET) or a similar program with a meal
 replacement formula and targeted nutraceuticals (PROG) in generally healthy, overweight
 subjects, forty to fifty subjects with two or more cardiometabolic risk factors, aged 18 to
 69 will be randomized into different arms, 13-week intervention trial. To evaluate safety and
 tolerability, questionnaires were collected weekly. Additionally, baseline, week 9 and 13
 fasting blood samples will be drawn for blood counts, metabolic profiles, plasma lipids, and
 additional cardiovascular risk factors. Vitals signs, weight and body composition were
 monitored weekly.
Inclusion Criteria:

 Generally healthy subjects (men and women ≥ 18 and ≤ 69 years old) were required:

 -  to be overweight or obese (BMI ≥ 27 kg/m2 and ≤ 50 kg/m2),

 -  to exhibit visceral obesity (waist circumference ≥ 35 inches for women and ≥ 39 inches
 for men),

 -  and demonstrate signs of cardiometabolic dysfunction. Specifically, subjects were
 required to have:

 -  elevated LDL cholesterol ≥ 130 mg/dl

 -  and/or elevated TG defined as TG ≥ 130 mg/dl. Additionally, subjects were required to
 have at least one of the following criteria (unless subject had both elevated LDL and
 TG):

 -  HDL < 50 mg/dl for women and < 40 mg/dl for men,

 -  blood glucose ≥ 100 mg/dl, HbA1C ≥ 5.7%,

 -  or Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score defined as ≥
 2.0.

 Exclusion Criteria included:

 -  Pregnancy

 -  Lactation

 -  Recent changes in prescription medications, over-the-counter medications, medical
 foods, and nutritional supplements

 -  Recent or regular use of narcotics, investigational drugs, corticosteroids,
 anticoagulants, neuroactive medications, or medication or supplements relevant to
 hyperglycemia or hyperlipidemia

 -  Chronic use of over-the-counter medication which would interfere with study endpoints
 including NSAIDS, laxatives and antacids

 -  Allergy or intolerance to study products

 -  Serious, unstable medical conditions including known infection with HIV, tuberculosis
 or hepatitis; cardiovascular disease; Diabetes Mellitus; autoimmune diseases;
 malignancy; psychiatric disease; substance abuse;

 -  Abnormal laboratory findings

 -  Participating in or planning to begin a weight loss diet during the study period

 -  Difficulty in swallowing pills

 -  Lifestyle or schedule incompatible with the study protocol.