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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROG2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROG2 | Other | Nutritional Supplements to be administered:
|
| 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 |
| 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 |
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Inclusion Criteria:
Generally healthy subjects (men and women ≥ 18 and ≤ 69 years old) were required:
Exclusion Criteria included:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph J Lamb, MD | Hughes Center for Research and Innovation | Principal Investigator |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |