Safety Evaluation of a Lifestyle Modification Program In.Form 1.1

Safety Evaluation of a Lifestyle Modification Program for Healthy Weight and Cardiometabolic Function

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: DIET; Dietary supplement: PROGRAM

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DIET; High Phyto-PRO food plan; Physical activity; Cognitive behavioral program	Other: DIET
Experimental: PROGRAM; High Phyto-PRO food plan; Physical activity; Cognitive Behavioral Program; Protein Shakes; Phytosterols supplement; Berberine supplement; Anti-oxidant supplement; Probiotic supplement; Fish Oil supplement; Multiple Vitamin/Multiple Mineral supplement	Other: DIET; Dietary supplement: PROGRAM

What is the study measuring?

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). Collected data 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 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 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 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 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

Collaborators and Investigators

• Sponsor: Nature's Sunshine Products, Inc.

Publications and helpful links

General Publications

• Dahlberg CJ, Ou JJ, Babish JG, Lamb JJ, Eliason S, Brabazon H, Gao W, Kaadige MR, Tripp ML. A 13-week low glycemic load diet and lifestyle modification program combining low glycemic load protein shakes and targeted nutraceuticals improved weight loss and cardio-metabolic risk factors. Can J Physiol Pharmacol. 2017 Dec;95(12):1414-1425. doi: 10.1139/cjpp-2016-0704. Epub 2017 Aug 11.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): November 20, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 25, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 25, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NSP-CT-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No