Effects of Soy Protein/Soy Fiber on Measures of Satiety

June 6, 2012 updated by: Solae, LLC

Effect of Addition of Soy Protein and Soy Fiber to a Snack Bar on Satiety and Food Intake

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, MeC2N8
        • Glycemic Index Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Other: Satiety
Single consumption of snack bars to determine satiety and food intake at next meal.
EXPERIMENTAL: Soy Protein
Other: Satiety
Single consumption of snack bars to determine satiety and food intake at next meal.
EXPERIMENTAL: Soy Fiber
Other: Satiety
Single consumption of snack bars to determine satiety and food intake at next meal.
EXPERIMENTAL: Soy Protein and Soy Fiber
Other: Satiety
Single consumption of snack bars to determine satiety and food intake at next meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satiety
Time Frame: at each visit (4 visits total)
visual analog scales for satiety
at each visit (4 visits total)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ad Libitum Energy Intake
Time Frame: at each visit (4 visits total)
Pizza lunch amount consumed will be measured
at each visit (4 visits total)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solae, LLC

Collaborators

Glycemic Index Laboratories, Inc

Investigators

  • Principal Investigator: Thomas Wolever, PhD, Glycemic Index Laboratories, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (ESTIMATE)

May 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GIL1103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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