Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01358318
Other study ID # GIL1103
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02897570 - Metabolic and Neurofunctional Responses to Breakfasts N/A
Completed NCT02471092 - The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood N/A
Completed NCT01305291 - Fibersol-2 Clinical Trials Related to Appetite N/A
Completed NCT01152047 - The Effect of Oxytocin on Gastric Emptying N/A
Completed NCT01587911 - Casinomacropeptide and Satiety N/A
Completed NCT02075788 - Millet Products Study - Investigation of Glycemic Index and Satiety N/A
Completed NCT01379911 - Developing Methods for Completing Future Satiety Studies N/A
Completed NCT02122224 - Breakfast Consumption in Preschoolers: Satiety, Diet Quality and Memory N/A