Satiating Effects of Isolated Soy Proteins

NCT ID: NCT01731197

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-11-30

Brief Summary

Proteins are known to be more satiating than the other macronutrients; however, the type and amount of protein needed to induce a significant effect on satiety (fullness between meals) is sometimes difficult to determine. In this study, 2 differentially processed isolated soy proteins will be tested for satiety using subjective visual analogue scales. The amount of food consumed following intake of the isolated soy proteins will be measured 3 hours after consuming the proteins. The hypothesis is that differentially processed isolated soy proteins will show unique satiety responses.

Conditions

Weight Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Test ISP-10

10 grams of the test ISP will be consumed as a dry-blended beverage

Group Type: EXPERIMENTAL

Dry-Blended Beverage

Intervention Type: DIETARY_SUPPLEMENT

Test ISP-20

20 grams of the test ISP will be consumed as a dry-blended beverage

Group Type: EXPERIMENTAL

Dry-Blended Beverage

Intervention Type: DIETARY_SUPPLEMENT

Control ISP-10

10 grams of the control ISP will be consumed as a dry-blended beverage

Group Type: ACTIVE_COMPARATOR

Dry-Blended Beverage

Intervention Type: DIETARY_SUPPLEMENT

Control ISP-20

20 grams of the control ISP will be consumed as a dry-blended beverage

Group Type: ACTIVE_COMPARATOR

Dry-Blended Beverage

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Dry-Blended Beverage

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• BMI between 20 and 30 kg/m2
• Age between 18-65y
• Unrestrained eater (score<12)
• 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. hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication, 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 within 4 weeks of study (eg weight loss diet, extremely high or low carbohydrate/protein/fat diet, use of meal replacements more than once a day)
• use of supplements within 1 week of study (does not include vitamin supplements or supplements which are routinely taken and were initiated 4 weeks before the study and which will be continued during the study period)
• restrained eater (score>12)
• weight change (absolute body weight change of ≥ 10%) within the previous 6 weeks
• alcohol intake >2 drinks/day
• food allergies of any kind
• swallowing difficulties
• exercising more than 7 hours per week

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DuPont Nutrition and Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Wolever, MD

Role: PRINCIPAL_INVESTIGATOR

Glycemic Index Laboratories, Inc

Alexandra Jenkins, PhD

Role: PRINCIPAL_INVESTIGATOR

Glycemic Index Laboratories, Inc

Locations

Glycemic Index Laboratories

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

GIL-1245

Identifier Type: -

Identifier Source: org_study_id