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

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ClinicalTrials.gov Identifier: NCT03741660
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
Dicofarm
University of Toronto
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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

Condition or disease Intervention/treatment Phase
Type2 Diabetes Coronary Heart Disease Dietary Supplement: konjac glucomannan Dietary Supplement: wheat bran Phase 2

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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: Konjac-Mannan (Glucomannan) Improves Glycemia and Other Associated Risk Factors for Coronary Heart Disease in Type 2 Diabetes
Actual Study Start Date : January 1991
Actual Primary Completion Date : June 1992
Actual Study Completion Date : June 1998

Resource links provided by the National Library of Medicine


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 (0.7 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 at week 3, relative to control ]
  2. change in fructosamine [ Time Frame: change from baseline at week 3, relative to control ]
  3. change in systolic blood pressure [ Time Frame: change from baseline at week 3, relative to control ]

Secondary Outcome Measures :
  1. change in total cholesterol [ Time Frame: change from baseline at week 3, relative to control ]
  2. change in LDL cholesterol [ Time Frame: change from baseline at week 3, relative to control ]
  3. change in HDL cholesterol [ Time Frame: change from baseline at week 3, relative to control ]
  4. change in apolipoprotein A-1 [ Time Frame: change from baseline at week 3, relative to control ]
  5. change in apolipoprotain B [ Time Frame: change from baseline at week 3, relative to control ]
  6. change in glucose [ Time Frame: change from baseline at week 3, relative to control ]
  7. change in insulin [ Time Frame: change from baseline at week 3, relative to control ]
  8. diastolic blood pressure [ Time Frame: change from baseline at week 3, relative to control ]
  9. change in body weight [ Time Frame: change from baseline at week 3, relative to control ]
  10. change in apoB:ApoA-1 [ Time Frame: change from baseline at week 3, relative to control ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03741660     History of Changes
Other Study ID Numbers: Konjac in T2DM
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 St. Michael's Hospital, Toronto:
konjac
type2 diabetes
fiber
coronary heart disease
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents