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Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02108691
Enrollment
80
Registered
2014-04-09
Start date
2014-05-31
Completion date
2014-07-31
Last updated
2015-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

DIETARY_SUPPLEMENTGlycin max(L.) Merr. peel extract

Glycin max(L.) Merr. peel extract (2.5g/day)

DIETARY_SUPPLEMENTPlacebo

Placebo (2.5g/day)

Sponsors

Hanyang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in Body Fat Mass8 weeksBody Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).

Secondary

MeasureTime frameDescription
Changes in Weight8 weeksWeight was measured in study visit 1(0 week)and visit 3(8 week).
Changes in BMI(Body Mass Index)8 weeksBMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week).
Changes in Percent Body Fat8 weeksPercent Body Fat was measured in study visit 1(0 week) and visit 3(8 week).
Changes in Non-HDLc8 weeksNon-HDLc was measured in study visit 1(0week) and visit 3(8 week).
Changes in LDLc/HDLc8 weeksLDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week).
Changes in LDLc8 weeksLDLc was measured in study visit 1(0week) and visit 3(8 week).

Countries

South Korea

Participant flow

Participants by arm

ArmCount
Glycin Max(L.) Merr. Pell Extract
Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
40
Placebo
Placebo: Placebo (2.5g/day)
40
Total80

Baseline characteristics

CharacteristicGlycin Max(L.) Merr. Pell ExtractPlaceboTotal
Age, Continuous30.30 years
STANDARD_DEVIATION 9.42
30.88 years
STANDARD_DEVIATION 9.18
30.59 years
STANDARD_DEVIATION 9.25
Sex: Female, Male
Female
16 Participants14 Participants30 Participants
Sex: Female, Male
Male
24 Participants26 Participants50 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 400 / 40
serious
Total, serious adverse events
0 / 400 / 40

Outcome results

Primary

Changes in Body Fat Mass

Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Glycin Max(L.) Merr. Pell ExtractChanges in Body Fat Mass0 week16790.27 gStandard Deviation 3524.04
Glycin Max(L.) Merr. Pell ExtractChanges in Body Fat Mass8 week20174.10 gStandard Deviation 4336.18
PlaceboChanges in Body Fat Mass0 week18223.75 gStandard Deviation 5325.29
PlaceboChanges in Body Fat Mass8 week21474.88 gStandard Deviation 6042.38
Secondary

Changes in BMI(Body Mass Index)

BMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week).

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Glycin Max(L.) Merr. Pell ExtractChanges in BMI(Body Mass Index)0 week27.62 kg/m^2Standard Deviation 1.63
Glycin Max(L.) Merr. Pell ExtractChanges in BMI(Body Mass Index)8 week27.22 kg/m^2Standard Deviation 1.77
PlaceboChanges in BMI(Body Mass Index)0 week28.29 kg/m^2Standard Deviation 1.91
PlaceboChanges in BMI(Body Mass Index)8 week28.00 kg/m^2Standard Deviation 2.04
Secondary

Changes in LDLc

LDLc was measured in study visit 1(0week) and visit 3(8 week).

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Glycin Max(L.) Merr. Pell ExtractChanges in LDLc0 week122.50 mg/dlStandard Deviation 33.71
Glycin Max(L.) Merr. Pell ExtractChanges in LDLc8 week98.47 mg/dlStandard Deviation 23.91
PlaceboChanges in LDLc0 week113.81 mg/dlStandard Deviation 35.16
PlaceboChanges in LDLc8 week104.06 mg/dlStandard Deviation 24.39
Secondary

Changes in LDLc/HDLc

LDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week).

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Glycin Max(L.) Merr. Pell ExtractChanges in LDLc/HDLc8 week2.02 ratioStandard Deviation 0.6
Glycin Max(L.) Merr. Pell ExtractChanges in LDLc/HDLc0 week2.21 ratioStandard Deviation 0.64
PlaceboChanges in LDLc/HDLc8 week2.15 ratioStandard Deviation 0.58
PlaceboChanges in LDLc/HDLc0 week2.04 ratioStandard Deviation 0.57
Secondary

Changes in Non-HDLc

Non-HDLc was measured in study visit 1(0week) and visit 3(8 week).

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Glycin Max(L.) Merr. Pell ExtractChanges in Non-HDLc0 week171.63 mg/dlStandard Deviation 38.08
Glycin Max(L.) Merr. Pell ExtractChanges in Non-HDLc8 week128.78 mg/dlStandard Deviation 32.19
PlaceboChanges in Non-HDLc0 week166.52 mg/dlStandard Deviation 46.45
PlaceboChanges in Non-HDLc8 week137.39 mg/dlStandard Deviation 37.24
Secondary

Changes in Percent Body Fat

Percent Body Fat was measured in study visit 1(0 week) and visit 3(8 week).

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Glycin Max(L.) Merr. Pell ExtractChanges in Percent Body Fat0 week24.28 percentageStandard Deviation 6.44
Glycin Max(L.) Merr. Pell ExtractChanges in Percent Body Fat8 week28.52 percentageStandard Deviation 7.44
PlaceboChanges in Percent Body Fat0 week25.15 percentageStandard Deviation 7.92
PlaceboChanges in Percent Body Fat8 week28.76 percentageStandard Deviation 8.58
Secondary

Changes in Weight

Weight was measured in study visit 1(0 week)and visit 3(8 week).

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Glycin Max(L.) Merr. Pell ExtractChanges in Weight0 week78.50 kgStandard Deviation 10.89
Glycin Max(L.) Merr. Pell ExtractChanges in Weight8 week77.36 kgStandard Deviation 10.89
PlaceboChanges in Weight0 week81.46 kgStandard Deviation 9.59
PlaceboChanges in Weight8 week80.60 kgStandard Deviation 9.57

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026