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

Overview

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

Full Title of Study: “Konjac-Mannan (Glucomannan) Improves Glycemia and Other Associated Risk Factors for Coronary Heart Disease in Type 2 Diabetes”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: June 1992

Interventions

• Dietary Supplement: konjac glucomannan
  • Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ [100kcal] of glucommanan)
• Dietary Supplement: wheat bran
  • Wheat bran (hard red wheat bran) fiber enriched biscuits

Arms, Groups and Cohorts

• Experimental: Konjac-mannan
  • Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet
• Placebo Comparator: Placebo
  • wheat bran fiber biscuits with NCEP Step II metabolically controlled diet

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Unity Health Toronto
• Collaborator
  • Dicofarm
• Provider of Information About this Clinical Study
  • Sponsor