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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03741686
Enrollment
11
Registered
2018-11-15
Start date
1991-01-31
Completion date
1999-06-30
Last updated
2018-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance Syndrome

Keywords

insulin resistance syndrome, fiber, konjac

Brief 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.

Interventions

DIETARY_SUPPLEMENTkonjac glucomannan

Konjac-mannan fiber-enriched biscuits (0.5 g/412KJ \[100kcal\] of glucommanan)

DIETARY_SUPPLEMENTwheat bran

Wheat bran (hard red wheat bran) fiber enriched biscuits

Sponsors

Dicofarm
CollaboratorOTHER
University of Toronto, Toronto
CollaboratorUNKNOWN
Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
change in total:HDL cholesterolchange from baseline after 3 weeks, relative to control
change in fructosaminechange from baseline after 3 weeks, relative to control
change in systolic blood pressurechange from baseline after 3 weeks, relative to control

Secondary

MeasureTime frame
change in apolipoprotein A-1change from baseline after 3 weeks, relative to control
change in apolipoprotain Bchange from baseline after 3 weeks, relative to control
change in glucosechange from baseline after 3 weeks, relative to control
change in total cholesterolchange from baseline after 3 weeks, relative to control
change in diastolic blood pressurechange from baseline after 3 weeks, relative to control
change in body weightchange from baseline after 3 weeks, relative to control
change in apoB:ApoA-1change from baseline after 3 weeks, relative to control
change in insulinchange from baseline after 3 weeks, relative to control
change in LDL cholesterolchange from baseline after 3 weeks, relative to control
change in HDL cholesterolchange from baseline after 3 weeks, relative to control

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026