NCT02108691CompletedPhase 2
Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hanyang University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes in Body Fat Mass
Study Overview
Brief Summary
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Males and females 19-65 years old
- •BMI(body mass index) ≥ 25 kg/m^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
- •Able to give informed consent
Exclusion Criteria
- •Significant variation in weight(more 10%) in the past 3 months
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •Pregnant or lactating women etc.
Arms & Interventions
Glycin max(L.) Merr. pell extract
Experimental
Intervention: Glycin max(L.) Merr. peel extract (Dietary Supplement)
Placebo
Placebo Comparator
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in Body Fat Mass
Time Frame: 8 weeks
Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).
Secondary Outcomes
- Changes in Percent Body Fat(8 weeks)
- Changes in Weight(8 weeks)
- Changes in BMI(Body Mass Index)(8 weeks)
- Changes in LDLc(8 weeks)
- Changes in Non-HDLc(8 weeks)
- Changes in LDLc/HDLc(8 weeks)
Investigators
Yongsoon Park
Associate Professor
Hanyang University
Study Sites (1)
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