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

NCT ID: NCT03741686

Last Updated: 2018-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-01-31

Study Completion Date

1999-06-30

Brief Summary

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

Detailed Description

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Conditions

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Insulin Resistance Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Konjac-mannan

Konjac-mannan fiber-enriched biscuits with NCEP Step II metabolically controlled diet.

Group Type EXPERIMENTAL

konjac glucomannan

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

wheat bran fiber biscuits with NCEP Step II metabolically controlled diet.

Group Type PLACEBO_COMPARATOR

wheat bran

Intervention Type DIETARY_SUPPLEMENT

Wheat bran (hard red wheat bran) fiber enriched biscuits

Interventions

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konjac glucomannan

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

Intervention Type DIETARY_SUPPLEMENT

wheat bran

Wheat bran (hard red wheat bran) fiber enriched biscuits

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dicofarm

OTHER

Sponsor Role collaborator

University of Toronto, Toronto

UNKNOWN

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Konjac in Insulin Resistance

Identifier Type: -

Identifier Source: org_study_id

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