Trials / Completed
CompletedNCT03097965
Safety Evaluation of a Lifestyle Modification Program In.Form 1.1
Safety Evaluation of a Lifestyle Modification Program for Healthy Weight and Cardiometabolic Function
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Nature's Sunshine Products, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 69 Years
- Healthy volunteers
- Accepted
Summary
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | PROGRAM | |
| OTHER | DIET |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2015-11-20
- Completion
- 2015-12-31
- First posted
- 2017-03-31
- Last updated
- 2017-03-31
Source: ClinicalTrials.gov record NCT03097965. Inclusion in this directory is not an endorsement.