NCT01731197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

November 15, 2012

Last Update Submit

October 3, 2019

Conditions

Weight Management

Keywords

obesity, isolated soy protein, satiety, food intake

Outcome Measures

Primary Outcomes (1)

  • Subjective Satiety

    Measure subjective satiety using visual analogue scales

    3 hours

Secondary Outcomes (1)

  • Ad Libitum Food Intake

    30 minutes

Study Arms (4)

Test ISP-10

EXPERIMENTAL

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

Dietary Supplement: Dry-Blended Beverage

Test ISP-20

EXPERIMENTAL

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

Dietary Supplement: Dry-Blended Beverage

Control ISP-10

ACTIVE COMPARATOR

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

Dietary Supplement: Dry-Blended Beverage

Control ISP-20

ACTIVE COMPARATOR

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

Dietary Supplement: Dry-Blended Beverage

Interventions

Dry-Blended BeverageDIETARY_SUPPLEMENT
Control ISP-10Control ISP-20Test ISP-10Test ISP-20

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories

Toronto, Ontario, M5C2N8, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Wolever, MD

    Glycemic Index Laboratories, Inc

    PRINCIPAL INVESTIGATOR

  • Alexandra Jenkins, PhD

    Glycemic Index Laboratories, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 21, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2013

Study Completion

November 1, 2013

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations

CA(1)