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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741660
• Other study ID #: Konjac in T2DM
• Status: Completed
• Phase: Phase 2
• Start date: January 1991
• Est. completion date: June 1998

Study information

• Verified date: November 2018
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 1998
• Est. primary completion date: June 1992
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Diabetes Mellitus, Type 2
• Heart Diseases
• Myocardial Ischemia
• Type2 Diabetes

Intervention

Dietary Supplement:
• konjac glucomannan
Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ [100kcal] of glucommanan)
• wheat bran
Wheat bran (hard red wheat bran) fiber enriched biscuits

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Dicofarm, University of Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in total:HDL cholesterol		change from baseline at week 3, relative to control
Primary	change in fructosamine		change from baseline at week 3, relative to control
Primary	change in systolic blood pressure		change from baseline at week 3, relative to control
Secondary	change in total cholesterol		change from baseline at week 3, relative to control
Secondary	change in LDL cholesterol		change from baseline at week 3, relative to control
Secondary	change in HDL cholesterol		change from baseline at week 3, relative to control
Secondary	change in apolipoprotein A-1		change from baseline at week 3, relative to control
Secondary	change in apolipoprotain B		change from baseline at week 3, relative to control
Secondary	change in glucose		change from baseline at week 3, relative to control
Secondary	change in insulin		change from baseline at week 3, relative to control
Secondary	diastolic blood pressure		change from baseline at week 3, relative to control
Secondary	change in body weight		change from baseline at week 3, relative to control
Secondary	change in apoB:ApoA-1		change from baseline at week 3, relative to control