Clinical trial NCT01358318: Effects of Soy Protein/Soy Fiber on Measures of Satiety
Official title: Effect of Addition of Soy Protein and Soy Fiber to a Snack Bar on Satiety and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lack of Satiety
Keywords: obesity
satiety
soy protein
soy fiber
control appetite
reduce food intake
Lead sponsor: Solae, LLC
Sponsor class: INDUSTRY
Collaborators: name: Glycemic Index Laboratories, Inc
First posted: 2011-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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 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

Primary outcomes:
measure: Satiety
timeFrame: at each visit (4 visits total)
Secondary outcomes:
measure: Ad Libitum Energy Intake
timeFrame: at each visit (4 visits total)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories
state: Ontario
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas Wolever, PhD
role: PRINCIPAL_INVESTIGATOR
References: