Lack of Satiety Clinical Trial
Official title:
Effect of Addition of Soy Protein and Soy Fiber to a Snack Bar on Satiety and Food Intake
Verified date | June 2012 |
Source | Solae, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Canada | Glycemic Index Laboratories | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Solae, LLC | Glycemic Index Laboratories, Inc |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Satiety | visual analog scales for satiety | at each visit (4 visits total) | No |
Secondary | Ad Libitum Energy Intake | Pizza lunch amount consumed will be measured | at each visit (4 visits total) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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