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OpenTrials
Completed

NCT Number: NCT03741660

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

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

Completed

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Key information

Conditions

Type2 Diabetes Cardiovascular Diseases Coronary Disease Coronary Heart Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–70 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

  • 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

Treatment and study plan

konjac glucomannan

Dietary Supplement

Konjac-mannan fiber-enriched biscuits (0.7 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 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Dicofarm
  • University of Toronto

Registry information

Official study title

Konjac-Mannan (Glucomannan) Improves Glycemia and Other Associated Risk Factors for Coronary Heart Disease in Type 2 Diabetes

Important dates

Study start
1991
Primary completion
1992
Study completion
1998
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.

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