NCT03098056

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Nature's Sunshine Products, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Obesity

Interventions

Type	Name	Description
OTHER	PROG2	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

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-11-18
• Completion: 2016-12-31
• First posted: 2017-03-31
• Last updated: 2017-04-04