Skip to main content
OpenTrials
Completed

NCT Number: NCT03741686

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insulin Resistance Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

konjac glucomannan

Dietary Supplement

Konjac-mannan fiber-enriched biscuits (0.5 g/412KJ [100kcal] of glucommanan)

Wheat Bran

Dietary Supplement

Wheat bran (hard red wheat bran) fiber enriched biscuits

Primary outcomes

  1. change in total:HDL cholesterol

    Time frame: change from baseline after 3 weeks, relative to control

  2. change in fructosamine

    Time frame: change from baseline after 3 weeks, relative to control

  3. change in systolic blood pressure

    Time frame: change from baseline after 3 weeks, relative to control

Secondary outcomes

  1. change in total cholesterol

    Time frame: change from baseline after 3 weeks, relative to control

  2. change in LDL cholesterol

    Time frame: change from baseline after 3 weeks, relative to control

  3. change in HDL cholesterol

    Time frame: change from baseline after 3 weeks, relative to control

  4. change in apolipoprotein A-1

    Time frame: change from baseline after 3 weeks, relative to control

  5. change in apolipoprotain B

    Time frame: change from baseline after 3 weeks, relative to control

  6. change in glucose

    Time frame: change from baseline after 3 weeks, relative to control

  7. change in insulin

    Time frame: change from baseline after 3 weeks, relative to control

  8. change in diastolic blood pressure

    Time frame: change from baseline after 3 weeks, relative to control

  9. change in body weight

    Time frame: change from baseline after 3 weeks, relative to control

  10. change in apoB:ApoA-1

    Time frame: change from baseline after 3 weeks, relative to control

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Dicofarm
  • University of Toronto

Registry information

Official study title

Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome

Important dates

Study start
1991
Primary completion
1992
Study completion
1999
First posted
Nov 15, 2018
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.