NCT04107155

Study to Evaluate the Effects of a Weight Management Program on Body Weight

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Weight Management Program on Body Weight in Individuals Who Are Overweight and Otherwise Healthy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Supplement Formulators, Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the safety and effectiveness of the Weight Management Program on body weight

Detailed description

This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a Weight Management program on body weight. Each subject will receive a specific dose of the study product (A) to be taken twice daily with breakfast and dinner and a specific dose of the study product (B) to be taken 15 minutes before lunch daily for a total of 60 days. Each subject based upon the randomization will also receive a handout with suggestions for healthy eating and overall health. Participants receive questionnaires, assessments, blood tests, vital signs and a body composition analysis. The primary objective is the assessment of the change in body weight in response to the Weight Management program relative to baseline compared with placebo The secondary objective is the assessment of the change in waist circumference, parameters from the body composition analysis, appetite, the levels of blood lipids and C-reactive protein in response to the Weight Management program relative to baseline compared with placebo

Conditions

• Body Weight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Weight Management Formulation	Saffron extract and Gynostemma extract with hesperidin
DIETARY_SUPPLEMENT	Placebo	Placebo
OTHER	Handout with Suggestions for Healthy Eating and Overall Health	Suggestions for Healthy Eating and Overall Health
OTHER	Handout with Suggestions for Healthy Eating and Overall Health	Suggestions for Healthy Eating and Overall Health

Timeline

• Start date: 2019-07-23
• Primary completion: 2019-11-29
• Completion: 2019-12-20
• First posted: 2019-09-27
• Last updated: 2020-03-17

Locations

1 site across 1 country: United States