Satiating Effects of Isolated Soy Proteins

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Solae, LLC
ClinicalTrials.gov Identifier:
NCT01731197
First received: November 15, 2012
Last updated: January 28, 2014
Last verified: January 2014
  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


Enrollment: 40
Study Start Date: November 2012
Study Completion Date: November 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Glycemic Index Laboratories
Toronto, Ontario, Canada, M5C2N8
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: January 28, 2014
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 October 29, 2014