Effects of Soy Protein/Soy Fiber on Measures of Satiety
Effect of Addition of Soy Protein and Soy Fiber to a Snack Bar on Satiety and Food Intake
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 19, 2011
CompletedFirst Posted
Study publicly available on registry
May 23, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJune 7, 2012
June 1, 2012
3 months
May 19, 2011
June 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Satiety
visual analog scales for satiety
at each visit (4 visits total)
Secondary Outcomes (1)
Ad Libitum Energy Intake
at each visit (4 visits total)
Study Arms (4)
Control
PLACEBO COMPARATORSoy Protein
EXPERIMENTALSoy Fiber
EXPERIMENTALSoy Protein and Soy Fiber
EXPERIMENTALInterventions
Single consumption of snack bars to determine satiety and food intake at next meal.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solae, LLClead
- Glycemic Index Laboratories, Inccollaborator
Study Sites (1)
Glycemic Index Laboratories
Toronto, Ontario, MeC2N8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Wolever, PhD
Glycemic Index Laboratories, Inc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2011
First Posted
May 23, 2011
Study Start
February 1, 2011
Primary Completion
May 1, 2011
Study Completion
September 1, 2011
Last Updated
June 7, 2012
Record last verified: 2012-06