Effects of Soy Protein/Soy Fiber on Measures of Satiety

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358318
• Other study ID #: GIL1103
• Status: Completed
• Phase: N/A
• First received: May 19, 2011
• Last updated: June 6, 2012
• Start date: February 2011
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: Solae, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lack of Satiety

Intervention

Other:
• Satiety
Single consumption of snack bars to determine satiety and food intake at next meal.

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Solae, LLC	Glycemic Index Laboratories, Inc

Country where clinical trial is conducted

Canada, 

Outcome

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