Trial Outcomes & Findings for Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight (NCT NCT02108691)

NCT ID: NCT02108691

Last Updated: 2015-05-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 80 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2015-05-22

Participant Flow

Participant milestones

Measure	Glycin Max(L.) Merr. Pell Extract Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)	Placebo Placebo: Placebo (2.5g/day)
Overall Study STARTED	40	40
Overall Study COMPLETED	32	31
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Glycin Max(L.) Merr. Pell Extract n=40 Participants Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)	Placebo n=40 Participants Placebo: Placebo (2.5g/day)	Total n=80 Participants Total of all reporting groups
Age, Continuous	30.30 years STANDARD_DEVIATION 9.42 • n=5 Participants	30.88 years STANDARD_DEVIATION 9.18 • n=7 Participants	30.59 years STANDARD_DEVIATION 9.25 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Glycin Max(L.) Merr. Pell Extract n=32 Participants Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)	Placebo n=31 Participants Placebo: Placebo (2.5g/day)
Changes in Body Fat Mass 0 week	16790.27 g Standard Deviation 3524.04	18223.75 g Standard Deviation 5325.29
Changes in Body Fat Mass 8 week	20174.10 g Standard Deviation 4336.18	21474.88 g Standard Deviation 6042.38

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Glycin Max(L.) Merr. Pell Extract n=32 Participants Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)	Placebo n=31 Participants Placebo: Placebo (2.5g/day)
Changes in Percent Body Fat 0 week	24.28 percentage Standard Deviation 6.44	25.15 percentage Standard Deviation 7.92
Changes in Percent Body Fat 8 week	28.52 percentage Standard Deviation 7.44	28.76 percentage Standard Deviation 8.58

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Glycin Max(L.) Merr. Pell Extract n=32 Participants Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)	Placebo n=31 Participants Placebo: Placebo (2.5g/day)
Changes in Weight 0 week	78.50 kg Standard Deviation 10.89	81.46 kg Standard Deviation 9.59
Changes in Weight 8 week	77.36 kg Standard Deviation 10.89	80.60 kg Standard Deviation 9.57

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Glycin Max(L.) Merr. Pell Extract n=32 Participants Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)	Placebo n=31 Participants Placebo: Placebo (2.5g/day)
Changes in BMI(Body Mass Index) 0 week	27.62 kg/m^2 Standard Deviation 1.63	28.29 kg/m^2 Standard Deviation 1.91
Changes in BMI(Body Mass Index) 8 week	27.22 kg/m^2 Standard Deviation 1.77	28.00 kg/m^2 Standard Deviation 2.04

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Glycin Max(L.) Merr. Pell Extract n=32 Participants Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)	Placebo n=31 Participants Placebo: Placebo (2.5g/day)
Changes in LDLc 0 week	122.50 mg/dl Standard Deviation 33.71	113.81 mg/dl Standard Deviation 35.16
Changes in LDLc 8 week	98.47 mg/dl Standard Deviation 23.91	104.06 mg/dl Standard Deviation 24.39

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Glycin Max(L.) Merr. Pell Extract n=32 Participants Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)	Placebo n=31 Participants Placebo: Placebo (2.5g/day)
Changes in Non-HDLc 0 week	171.63 mg/dl Standard Deviation 38.08	166.52 mg/dl Standard Deviation 46.45
Changes in Non-HDLc 8 week	128.78 mg/dl Standard Deviation 32.19	137.39 mg/dl Standard Deviation 37.24

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Glycin Max(L.) Merr. Pell Extract n=32 Participants Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)	Placebo n=31 Participants Placebo: Placebo (2.5g/day)
Changes in LDLc/HDLc 0 week	2.21 ratio Standard Deviation 0.64	2.04 ratio Standard Deviation 0.57
Changes in LDLc/HDLc 8 week	2.02 ratio Standard Deviation 0.60	2.15 ratio Standard Deviation 0.58

Adverse Events

Glycin Max(L.) Merr. Pell Extract

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yongsoon Park

Hanyang University

Phone: 82-2-2220-1205

Email: yongsoon@hanyang.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place