- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01731197
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
Intervention / Treatment
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.
Sponsor
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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