Satiety Study of a Carbohydrate Meal to a Highly Viscous Gel Meal

NCT ID: NCT01875627

Last Updated: 2013-06-12

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

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-01-31

Brief Summary

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To evaluate the effects of Konjac on satiety and subsequent food intake in healthy individuals.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Carbohydrate Noodles

0g Konjac Noodles

Group Type PLACEBO_COMPARATOR

Konjac noodles

Intervention Type DIETARY_SUPPLEMENT

Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal)

Carbohydrate and Konjac Noodles

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate noodles

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate and Konjac Noodles

Half Carbohydrate and Half Non-Caloric Konjac Noodles - 122.5g Konjac

Group Type EXPERIMENTAL

Konjac noodles

Intervention Type DIETARY_SUPPLEMENT

Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal)

Carbohydrate and Konjac Noodles

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate noodles

Intervention Type DIETARY_SUPPLEMENT

Konjac Noodles

Non-Caloric Konjac Noodles (viscous gel meal) - 240g Konjac

Group Type EXPERIMENTAL

Konjac noodles

Intervention Type DIETARY_SUPPLEMENT

Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal)

Carbohydrate and Konjac Noodles

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate noodles

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Konjac noodles

Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal)

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate and Konjac Noodles

Intervention Type DIETARY_SUPPLEMENT

Carbohydrate noodles

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Capellini n°1 Konnyaku - Konjac Noodles Wellbond Import export Scarborough, Ontario MIW 2P7 Konnyaku - Konjac Noodles Wellbond Import export Scarborough, Ontario MIW 2P7 Barilla America Inc. Bannockburn, Il 60015 Capellini n°1 Barilla America Inc. Bannockburn, Il 60015

Eligibility Criteria

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Inclusion Criteria

* Men and women
* Age 18-65 years
* Having a BMI of 18.5 - 25 kg/m2
* No presence of major disease

Exclusion Criteria

* Known history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, gastrointestinal disease, AIDS or AIDS-related complications; subjects using prescription medications or Natural Health Products; Subjects will be excluded if they have any condition which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimir Vuksan, PhD

Role: PRINCIPAL_INVESTIGATOR

Risk Factor Modification Centre - St. Michael's Hospital

Locations

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Risk Factor Modification Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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10-353

Identifier Type: -

Identifier Source: org_study_id

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