Satiating Effects of Isolated Soy Proteins

DuPont

Status: Completed

Conditions: Weight Management

Treatments: Dietary Supplement: Dry-Blended Beverage

Study type: Interventional

Funder types: Industry

Identifiers

NCT01731197

GIL-1245

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

40 participants in 4 patient groups

Test ISP-10

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dry-Blended Beverage

Test ISP-20

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dry-Blended Beverage

Control ISP-10

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Dry-Blended Beverage

Control ISP-20

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Dry-Blended Beverage