Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome

Phase 2

Completed

• Conditions: Insulin Resistance Syndrome
• Interventions: Dietary Supplement: konjac glucomannan; Dietary Supplement: wheat bran

• Registration Number: NCT03741686
• Lead Sponsor: Unity Health Toronto

Brief Summary

To study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 1991-01
• Primary Completion: 1992-06
• Study Completion: 1999-06
• Status Verified: 2018-11
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-15
• Last Update Posted: 2018-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Impaired glucose tolerant
• Clinical absent of CHD
• BMI less than 30 kg/m2
• Presence of full insulin resistance syndrome
• Reduced HDL cholesterol
• Elevated serum triglycerides
• Moderate hypertension

Exclusion Criteria

• Regular smoking
• Regular alcohol consumption
• Family history of premature coronary heart disease
• Hypothyroidism
• Renal, hepatic or gastrointestinal disease
• Taking medications for hyperglycemia
• Taking medications for hyperlipidemia
• Taking medications for hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Konjac-mannan	konjac glucomannan	Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet.
Placebo	wheat bran	wheat bran fiber biscuits with NCEP Step II metabolically controlled diet.

Primary Outcome Measures

Name	Time	Method
change in fructosamine	change from baseline after 3 weeks, relative to control
change in systolic blood pressure	change from baseline after 3 weeks, relative to control
change in total:HDL cholesterol	change from baseline after 3 weeks, relative to control

Secondary Outcome Measures

Name	Time	Method
change in total cholesterol	change from baseline after 3 weeks, relative to control
change in LDL cholesterol	change from baseline after 3 weeks, relative to control
change in glucose	change from baseline after 3 weeks, relative to control
change in insulin	change from baseline after 3 weeks, relative to control
change in HDL cholesterol	change from baseline after 3 weeks, relative to control
change in apolipoprotein A-1	change from baseline after 3 weeks, relative to control
change in apolipoprotain B	change from baseline after 3 weeks, relative to control
change in diastolic blood pressure	change from baseline after 3 weeks, relative to control
change in body weight	change from baseline after 3 weeks, relative to control
change in apoB:ApoA-1	change from baseline after 3 weeks, relative to control