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Satiating Effects of Isolated Soy Proteins

This study is currently recruiting participants.
Verified November 2012 by Solae, LLC
Sponsor:
Information provided by (Responsible Party):
Solae, LLC
ClinicalTrials.gov Identifier:
NCT01731197
First received: November 15, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Weight Management
 Dietary Supplement: Dry-Blended Beverage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Satiating Effects of Differentially Processed Isolated Soy Proteins

Further study details as provided by Solae, LLC:

Primary Outcome Measures:
  • Subjective Satiety [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Measure subjective satiety using visual analogue scales


Secondary Outcome Measures:
  • Ad Libitum Food Intake [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    At the end of 3 hours after consuming test diets, measure the amount of food consumed for 30 mins


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test ISP-10
10 grams of the test ISP will be consumed as a dry-blended beverage
 Dietary Supplement: Dry-Blended Beverage
Experimental: Test ISP-20
20 grams of the test ISP will be consumed as a dry-blended beverage
 Dietary Supplement: Dry-Blended Beverage
Active Comparator: Control ISP-10
10 grams of the control ISP will be consumed as a dry-blended beverage
 Dietary Supplement: Dry-Blended Beverage
Active Comparator: Control ISP-20
20 grams of the control ISP will be consumed as a dry-blended beverage
 Dietary Supplement: Dry-Blended Beverage

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731197

Contacts
Contact: Thomas Wolever, PhD 416-978-5556 thomas.wolever@utoronto.ca
Contact: Alexandra Jenkins, PhD 416-861-0506 ext 200 alexandrajenkins@gilabs.com

Locations
Canada, Ontario
Glycemic Index Laboratories Recruiting
Toronto, Ontario, Canada, M5C2N8
Contact: Alexandra Jenkins, PhD     416 861 9782     alexandrajenkins@gilabs.com    
Contact: Janice Campbell            
Principal Investigator: Thomas Wolever, MD            
Sponsors and Collaborators
Solae, LLC
Investigators
Principal Investigator: Thomas Wolever, MD Glycemic Index Laboratories, Inc
Principal Investigator: Alexandra Jenkins, PhD Glycemic Index Laboratories, Inc
  More Information

No publications provided

Responsible Party: Solae, LLC
ClinicalTrials.gov Identifier: NCT01731197     History of Changes
Other Study ID Numbers: GIL-1245
Study First Received: November 15, 2012
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Solae, LLC:
obesity, isolated soy protein, satiety, food intake

ClinicalTrials.gov processed this record on May 16, 2013