Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM

Phase 2

Completed

• Conditions: Coronary Heart Disease; Type2 Diabetes
• Interventions: Dietary Supplement: konjac glucomannan; Dietary Supplement: wheat bran

• Registration Number: NCT03741660
• Lead Sponsor: Unity Health Toronto

Brief Summary

To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 1991-01
• Primary Completion: 1992-06
• Study Completion: 1998-06
• 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

• hyperlipidemia controlled by medication
• hypertension controlled by medication
• type 2 diabetes controlled by medication
• minimum 3 years since onset of all three conditions
• sedentary lifestyle

Exclusion Criteria

• regular smoking
• regular alcohol consumption
• family history of premature coronary heart disease
• hypothyroidism
• renal, hepatic or gastrointestinal disease

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 total:HDL cholesterol	change from baseline at week 3, relative to control
change in fructosamine	change from baseline at week 3, relative to control
change in systolic blood pressure	change from baseline at week 3, relative to control

Secondary Outcome Measures

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