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

Overview

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

Full Title of Study: “Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome”

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 (0.5 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 after 3 weeks, relative to control
  • change in fructosamine
    • Time Frame: change from baseline after 3 weeks, relative to control
  • change in systolic blood pressure
    • Time Frame: change from baseline after 3 weeks, relative to control

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

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

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