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Effects of Soy Protein/Soy Fiber on Measures of Satiety

This study has been completed.
Sponsor:
Collaborator:
Glycemic Index Laboratories, Inc
Information provided by (Responsible Party):
Solae, LLC
ClinicalTrials.gov Identifier:
NCT01358318
First received: May 19, 2011
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Lack of Satiety
 Other: Satiety

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Addition of Soy Protein and Soy Fiber to a Snack Bar on Satiety and Food Intake

Resource links provided by NLM:

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Further study details as provided by Solae, LLC:

Primary Outcome Measures:
  • Satiety [ Time Frame: at each visit (4 visits total) ] [ Designated as safety issue: No ]
    visual analog scales for satiety


Secondary Outcome Measures:
  • Ad Libitum Energy Intake [ Time Frame: at each visit (4 visits total) ] [ Designated as safety issue: No ]
    Pizza lunch amount consumed will be measured


Enrollment: 40
Study Start Date: February 2011
Study Completion Date: September 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358318

Locations
Canada, Ontario
Glycemic Index Laboratories
Toronto, Ontario, Canada, MeC2N8
Sponsors and Collaborators
Solae, LLC
Glycemic Index Laboratories, Inc
Investigators
Principal Investigator: Thomas Wolever, PhD Glycemic Index Laboratories, Inc
  More Information

No publications provided

Responsible Party: Solae, LLC
ClinicalTrials.gov Identifier: NCT01358318     History of Changes
Other Study ID Numbers: GIL1103
Study First Received: May 19, 2011
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Solae, LLC:
obesity
satiety
soy protein
 soy fiber
control appetite
reduce food intake

ClinicalTrials.gov processed this record on May 21, 2013