Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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):
St. Michael's Hospital, Toronto

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Layout table for additonal information
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03741686     History of Changes
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Michael's Hospital, Toronto:
insulin resistance syndrome
fiber
konjac

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Insulin Resistance
Metabolic Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
(1-6)-alpha-glucomannan
Hypoglycemic Agents
Physiological Effects of Drugs
Cathartics
Gastrointestinal Agents