Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome

Insulin Resistance Syndrome Clinical Trial

Official title:

Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03741686
• Other study ID #: Konjac in Insulin Resistance
• Status: Completed
• Phase: Phase 2
• Start date: January 1991
• Est. completion date: June 1999

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 study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 1999
• Est. primary completion date: June 1992
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Resistance Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• konjac glucomannan
Konjac-mannan fiber-enriched biscuits (0.5 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, Toronto

Outcome

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