Phase 3
Completed N=80
Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight
Source: ClinicalTrials.gov NCT02108691 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Changes in Body Fat Mass — 16790.27; 18223.75; 20174.10; 21474.88 g
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Body Fat Mass |
16790.27; 18223.75; 20174.10; 21474.88 | — |
| SECONDARY Changes in Percent Body Fat |
24.28; 25.15; 28.52; 28.76 | — |
| SECONDARY Changes in Weight |
78.50; 81.46; 77.36; 80.60 | — |
| SECONDARY Changes in BMI(Body Mass Index) |
27.62; 28.29; 27.22; 28.00 | — |
| SECONDARY Changes in LDLc |
122.50; 113.81; 98.47; 104.06 | — |
| SECONDARY Changes in Non-HDLc |
171.63; 166.52; 128.78; 137.39 | — |
| SECONDARY Changes in LDLc/HDLc |
2.21; 2.04; 2.02; 2.15 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02108691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.