Satiating Effects of Isolated Soy Proteins

October 3, 2019 updated by: DuPont Nutrition and Health

Comparison of the Satiating Effects of Differentially Processed Isolated Soy Proteins

Proteins are known to be more satiating than the other macronutrients; however, the type and amount of protein needed to induce a significant effect on satiety (fullness between meals) is sometimes difficult to determine. In this study, 2 differentially processed isolated soy proteins will be tested for satiety using subjective visual analogue scales. The amount of food consumed following intake of the isolated soy proteins will be measured 3 hours after consuming the proteins. The hypothesis is that differentially processed isolated soy proteins will show unique satiety responses.

Study Overview

Status

Completed

Conditions

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

    • Ontario
      • Toronto, Ontario, Canada, M5C2N8
        • 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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI between 20 and 30 kg/m2
  • Age between 18-65y
  • Unrestrained eater (score<12)
  • 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. hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication, 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 within 4 weeks of study (eg weight loss diet, extremely high or low carbohydrate/protein/fat diet, use of meal replacements more than once a day)
  • use of supplements within 1 week of study (does not include vitamin supplements or supplements which are routinely taken and were initiated 4 weeks before the study and which will be continued during the study period)
  • restrained eater (score>12)
  • weight change (absolute body weight change of ≥ 10%) 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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Test ISP-10
10 grams of the test ISP will be consumed as a dry-blended beverage
EXPERIMENTAL: Test ISP-20
20 grams of the test ISP will be consumed as a dry-blended beverage
ACTIVE_COMPARATOR: Control ISP-10
10 grams of the control ISP will be consumed as a dry-blended beverage
ACTIVE_COMPARATOR: Control ISP-20
20 grams of the control ISP will be consumed as a dry-blended beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Satiety
Time Frame: 3 hours
Measure subjective satiety using visual analogue scales
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ad Libitum Food Intake
Time Frame: 30 minutes
At the end of 3 hours after consuming test diets, measure the amount of food consumed for 30 mins
30 minutes

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Thomas Wolever, MD, Glycemic Index Laboratories, Inc
  • Principal Investigator: Alexandra Jenkins, 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

November 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

November 15, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (ESTIMATE)

November 21, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 3, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • GIL-1245

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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