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CompletedNCT01358318Updated Jun 7, 2012

Effects of Soy Protein/Soy Fiber on Measures of Satiety

An interventional study of Satiety in Lack of Satiety, sponsored by Solae, LLC. Completed at 1 site in Canada. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-07.

Sponsored by Solae, LLC · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Lack of Satiety

Keywords

  • obesity
  • satiety
  • soy protein
  • soy fiber
  • control appetite
  • reduce food intake
03

In context

Lead sponsor

Solae, LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    Control

    Other: Satiety

  • Experimental
    Soy Protein

    Other: Satiety

  • Experimental
    Soy Fiber

    Other: Satiety

  • Experimental
    Soy Protein and Soy Fiber

    Other: Satiety

Interventions

  • OtherSatiety

    Single consumption of snack bars to determine satiety and food intake at next meal.

06

What researchers measure

Primary outcomes

  1. Satiety

    visual analog scales for satiety

    Time frame: at each visit (4 visits total)

Secondary outcomes

  1. Ad Libitum Energy Intake

    Pizza lunch amount consumed will be measured

    Time frame: at each visit (4 visits total)

07

Study locations

1 site
  • Glycemic Index Laboratories
    Toronto, Ontario MeC2N8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01358318
Lead sponsor
Solae, LLC
Collaborators
Glycemic Index Laboratories, Inc
Responsible party
Sponsor
First posted
May 23, 2011
Start date
Feb 2011
Primary completion
May 2011
Completion
Sep 2011
Last update
Jun 7, 2012

Study contacts

Thomas Wolever, PhD
principal investigator · Glycemic Index Laboratories, Inc
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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