Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Tracking Information
First Submitted Date  ICMJE November 7, 2018
First Posted Date  ICMJE November 15, 2018
Last Update Posted Date November 15, 2018
Actual Study Start Date  ICMJE January 1991
Actual Primary Completion Date June 1992   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • change in total:HDL cholesterol [ Time Frame: change from baseline at week 3, relative to control ]
  • change in fructosamine [ Time Frame: change from baseline at week 3, relative to control ]
  • change in systolic blood pressure [ Time Frame: change from baseline at week 3, relative to control ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2018)
  • change in total cholesterol [ Time Frame: change from baseline at week 3, relative to control ]
  • change in LDL cholesterol [ Time Frame: change from baseline at week 3, relative to control ]
  • change in HDL cholesterol [ Time Frame: change from baseline at week 3, relative to control ]
  • change in apolipoprotein A-1 [ Time Frame: change from baseline at week 3, relative to control ]
  • change in apolipoprotain B [ Time Frame: change from baseline at week 3, relative to control ]
  • change in glucose [ Time Frame: change from baseline at week 3, relative to control ]
  • change in insulin [ Time Frame: change from baseline at week 3, relative to control ]
  • diastolic blood pressure [ Time Frame: change from baseline at week 3, relative to control ]
  • change in body weight [ Time Frame: change from baseline at week 3, relative to control ]
  • change in apoB:ApoA-1 [ Time Frame: change from baseline at week 3, relative to control ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Konjac-Mannan Improves Glycemia and Other Risk Factors for CHD in T2DM
Official Title  ICMJE Konjac-Mannan (Glucomannan) Improves Glycemia and Other Associated Risk Factors for Coronary Heart Disease in Type 2 Diabetes
Brief Summary To examine whether Konjac-mannan fiber improves metabolic control measured by glycemia, lipidemia, and blood pressure in individuals with type-2 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Type2 Diabetes
  • Coronary Heart Disease
Intervention  ICMJE
  • Dietary Supplement: konjac glucomannan
    Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ [100kcal] of glucommanan)
  • Dietary Supplement: wheat bran
    Wheat bran (hard red wheat bran) fiber enriched biscuits
Study Arms  ICMJE
  • Experimental: Konjac-mannan
    Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet
    Intervention: Dietary Supplement: konjac glucomannan
  • Placebo Comparator: Placebo
    wheat bran fiber biscuits with NCEP Step II metabolically controlled diet
    Intervention: Dietary Supplement: wheat bran
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2018)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1998
Actual Primary Completion Date June 1992   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03741660
Other Study ID Numbers  ICMJE Konjac in T2DM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE
  • Dicofarm
  • University of Toronto
Investigators  ICMJE Not Provided
PRS Account St. Michael's Hospital, Toronto
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP