Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT03098056
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2017-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerance of a Nutritional Intervention Program- In.Form 1.2
Sponsor:
Nature's Sunshine Products, Inc.
Organization:
Study Overview
Official Title:
Safety Evaluation of a Lifestyle Modification Program for Healthy Weight and Cardiometabolic Function - Second Phase
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: