Trial Outcomes & Findings for Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome (NCT NCT02711306)

NCT ID: NCT02711306

Last Updated: 2019-10-29

Results Overview

Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2019-10-29

Participant Flow

Participant milestones

Measure	First GMN Then PN "First Intervention (4 weeks, GMN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, PN)"	First PN Then GMN "First Intervention (4 weeks, PN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, GMN)"
Overall Study STARTED	18	18
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	First GMN Then PN "First Intervention (4 weeks, GMN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, PN)"	First PN Then GMN "First Intervention (4 weeks, PN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, GMN)"
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome

Baseline characteristics by cohort

Measure	First GMN Then PN n=16 Participants "First Intervention (4 weeks, GMN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, PN)"	First PN Then GMN n=16 Participants "First Intervention (4 weeks, PN)", "Washout (2 weeks)" and "Second Intervention (4 weeks, GMN)"	Total n=32 Participants Total of all reporting groups
Age, Continuous	57.75 years STANDARD_DEVIATION 4.96 • n=5 Participants	49.82 years STANDARD_DEVIATION 12.59 • n=7 Participants	50.79 years STANDARD_DEVIATION 10.78 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.

Outcome measures

Measure	PN Diet n=32 Participants In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.	GMN Diet n=32 Participants In the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan.
Body Weight Baseline	74.97 kg Standard Deviation 11.44	75.2 kg Standard Deviation 10.86
Body Weight End	74.39 kg Standard Deviation 11.27	74.41 kg Standard Deviation 10.49

SECONDARY outcome

Timeframe: 4 weeks

Body waist by tape in centimeter

Outcome measures

Measure	PN Diet n=32 Participants In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.	GMN Diet n=32 Participants In the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan.
Waist Circumference Baseline	91.14 cm Standard Deviation 7.26	92.03 cm Standard Deviation 6.69
Waist Circumference End	90.15 cm Standard Deviation 7.11	90.17 cm Standard Deviation 6.8

SECONDARY outcome

Timeframe: 4 weeks

HbA1c (glycated hemoglobin) analysis

Outcome measures

Measure	PN Diet n=32 Participants In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.	GMN Diet n=32 Participants In the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan.
Glycemic Index Baseline	7.21 percentage Standard Deviation 1.69	7.28 percentage Standard Deviation 1.65
Glycemic Index End	7.12 percentage Standard Deviation 1.6	7.08 percentage Standard Deviation 1.54

SECONDARY outcome

Timeframe: 4 weeks

LDL-C (low density lipoprotein cholesterol) analysis

Outcome measures

Measure	PN Diet n=32 Participants In the placebo noodle (PN) diet, the participants received the participants received the same amount of noodles without glucomannan.	GMN Diet n=32 Participants In the glucomannan noodle (GMN) diet, the participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks, with each serving of glucomannan noodles weighing up to 200 g with 2 g of glucomannan.
Lipid Index Baseline	135.39 mg/dL Standard Deviation 28.02	133.86 mg/dL Standard Deviation 32.54
Lipid Index End	130.53 mg/dL Standard Deviation 33.63	137.24 mg/dL Standard Deviation 33.99

Adverse Events

GMN Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PN Diet

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. Sing-Chung Li

Taipei Medical University

Phone: 886-2-27361661

Email: sinchung@tmu.edu.tw

Results disclosure agreements

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