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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03741686
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
Dicofarm
University of Toronto, Toronto
Information provided by (Responsible Party):
Unity Health Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Syndrome Dietary Supplement: konjac glucomannan Dietary Supplement: wheat bran Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome
Actual Study Start Date : January 1991
Actual Primary Completion Date : June 1992
Actual Study Completion Date : June 1999

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Konjac-mannan
Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet.
 Dietary Supplement: konjac glucomannan
Konjac-mannan fiber-enriched biscuits (0.5 g/412KJ [100kcal] of glucommanan)
Placebo Comparator: Placebo
wheat bran fiber biscuits with NCEP Step II metabolically controlled diet.
 Dietary Supplement: wheat bran
Wheat bran (hard red wheat bran) fiber enriched biscuits


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT03741686    
Other Study ID Numbers: Konjac in Insulin Resistance
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Health Toronto:
insulin resistance syndrome
fiber
konjac
Additional relevant MeSH terms:
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Insulin Resistance
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents