Safety and Tolerance of a Nutritional Intervention Program- In.Form 1.2

Study Overview
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Brief Summary
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The study evaluated and the safety, tolerance and acceptability of a lifestyle modification program with nutritional supplementation in generally healthy overweight subjects with cardiometabolic risk factors. Experience will be compared to a historical controls.

Detailed Description
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To investigate the safety, tolerance and acceptability of a low-glycemic load diet combined with exercise and lifestyle modification education and a meal replacement formula and targeted nutraceuticals (PROG 2) in generally healthy, overweight subjects, 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.

Official Title
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Safety Evaluation of a Lifestyle Modification Program for Healthy Weight and Cardiometabolic Function - Second Phase

Conditions
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Obesity

Intervention / Treatment
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* Other: PROG2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROG2<br>All subjects will be participating in a lifestyle change program - specifically a high protein, limited carbohydrate food plan (High Phyto-PRO food plan), physical activity and a cognitive behavioral program consisting of 11 group visit. Participants will be recieving nutritional Supplements. | Other: PROG2<br>* Nutritional Supplements to be administered: Protein Shakes: one shake po twice daily Phytosterol supplement: one capsule po twice daily Cinnamon: one tablet twice daily Fiber supplement; one shake twice daily Antioxidant supplement: 2 capsules daily with dinner Fish Oil supplement: 1 capsule twice daily with food Probiotic supplement: 1 capsule twice daily with food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | Data collection including questionnaires at individual and group visits and physician interviews at individual visits (baseline, week 9 and week 13) will be used to assess participants for treatment-related adverse events. | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related changes in basic safety labs | Phlebotomy will be conducted at individual visits (baseline, week 9 and week 13). Comprehensive Metabolic Panels and Complete Blood Counts will be assessed for treatment-related change from baseline. | 13 weeks | 
| Number of participants with treatment-related changes in vital signs | Blood pressure and peripheral pulse will be monitored at individual visits (baseline, week 9 and week 13). Comprehensive Metabolic Panels and Complete Blood Counts will be assessed for treatment-related change from baseline. | 13 weeks | 
| Change in weight in pounds compared to baseline | Weight in pounds will be monitored (Tanita body composition monitor) at individual visits (baseline, week 9 and week 13) and group visits. Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in body fat in percentage compared to baseline | Body fat in percentage will be monitored (Tanita body composition monitor) at individual visits (baseline, week 9 and week 13) and group visits. Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in BMI in kg/m2 compared to baseline | BMI in kg/m2 will be monitored (Tanita body composition monitor) at individual visits (baseline, week 9 and week 13) and group visits. Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in waist circumference in inches compared to baseline | Waist circumference in inches will be monitored (Tanita body composition monitor) at individual visits (baseline, week 9 and week 13) and group visits. Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in Total Cholesterol in mg/dl compared to baseline | Total Cholesterol in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in LDL-Cholesterol in mg/dl compared to baseline | LDL-Cholesterol in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in oxidized LDL-Cholesterol in mg/dl compared to baseline | Oxidized LDL-Cholesterol in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in HDL-Cholesterol in mg/dl compared to baseline | HDL-Cholesterol in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in Triglycerides in mg/dl compared to baseline | Triglycerides in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in fasting glucose in mg/dl compared to baseline | Fasting glucose in mg/dl will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in fasting Insulin in mIU/l compared to baseline | Fasting Insulin in mIU/l will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in Hemoglobin A1c in percentage in mIU/l compared to baseline | Hemoglobin A1c in percentage will be measured at individual visits (baseline, week 9 and week 13). Collected data will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in Metabolic Syndrome Score compared to baseline | A Metabolic Syndrome score (0-5) will be calculated for participants at individual visits (baseline, week 9 and week 13). The five features of Metabolic Syndrome (visceral adiposity based on waist circumference, hyperglycemia, hypertension (or use of antihypertensives), hypertriglyceridemia and low HDL-Cholesterol will each be assigned a point value of 1. Subjects will receive 1 point for each feature they demonstrate on collected data. Score will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks | 
| Change in Framingham Risk Assessment Score compared to baseline | The Framingham Risk Assessment Score will be calculated for participants at individual visits (baseline, week 9 and week 13). Score will be assessed for treatment-related change from baseline. Comparison will be made between DIET and PROGRAM arms. | 13 weeks |