Effects of Soy Protein/Soy Fiber on Measures of Satiety

NCT ID: NCT01358318

Last Updated: 2012-06-07

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to determine whether ingestion of a bar containing either added soy protein or soy fiber or both, increases subjective and objective measures of satiety compared to a control bar.

Detailed Description

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The study will use a randomized, double blind crossover design in which subjects act as their own control. Satiation will be assessed using a Motivation to Eat Questionnaire. Height and weight will be measured at the screening visit and weight alone at each subsequent visit. Prior to consumption of the test meal (breakfast) and at 15, 30, 60, 90, 120 and 150 min thereafter, subjects will complete a VAS Motivation to Eat Questionnaire. After subjects complete the first VAS motivation questionnaire, they will be given the test meal and instructed to eat this over a 15 minute period and fill out a palatability questionnaire. Two hours after the start of the test meal they will be taken to a private feeding room, where an ad libitum pizza lunch will be served with mineral water. Participants will be instructed to eat and drink as much as they desire until they are comfortably full. Subjects will be asked to fill out a final VAS Motivation to eat questionnaire 30 min after the start of the pizza meal.

Conditions

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Lack of Satiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

Satiety

Intervention Type OTHER

Single consumption of snack bars to determine satiety and food intake at next meal.

Soy Protein

Group Type EXPERIMENTAL

Satiety

Intervention Type OTHER

Single consumption of snack bars to determine satiety and food intake at next meal.

Soy Fiber

Group Type EXPERIMENTAL

Satiety

Intervention Type OTHER

Single consumption of snack bars to determine satiety and food intake at next meal.

Soy Protein and Soy Fiber

Group Type EXPERIMENTAL

Satiety

Intervention Type OTHER

Single consumption of snack bars to determine satiety and food intake at next meal.

Interventions

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Satiety

Single consumption of snack bars to determine satiety and food intake at next meal.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI between 20 and 30 kg/m2
* Age between 20-60y
* Unrestrained eater (score\<15)
* Regularly consume 3 meals per day
* Moderate exercise (eg running , aerobics classes, other sports activities) of no more than 7 hours per week

Exclusion Criteria

* use of drugs that influence carbohydrate or lipid metabolism (eg betablockers,hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication etc), and anti-diabetic medication
* presence of any significant disease (eg gastrointestinal diseases, diabetes, a CVD event less than 12 weeks from study entry, current hepatic disease etc)
* use of special dietary treatments or supplement within 4 weeks of study
* restrained eater (score\>15)
* weight change (±10% of body weight) within the previous 6 weeks
* alcohol intake \>2 drinks/day
* food allergies of any kind
* swallowing difficulties,
* exercising more than 7 hours per week
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glycemic Index Laboratories, Inc

INDUSTRY

Sponsor Role collaborator

Solae, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Wolever, PhD

Role: PRINCIPAL_INVESTIGATOR

Glycemic Index Laboratories, Inc

Locations

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Glycemic Index Laboratories

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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GIL1103

Identifier Type: -

Identifier Source: org_study_id

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