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Completed

NCT Number: NCT01358318

Effects of Soy Protein/Soy Fiber on Measures of Satiety

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.

Completed

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glycemic Index Laboratories

Toronto, Ontario, MeC2N8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Satiety

Other

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

Primary outcomes

  1. Satiety

    Time frame: at each visit (4 visits total)

    visual analog scales for satiety

Secondary outcomes

  1. Ad Libitum Energy Intake

    Time frame: at each visit (4 visits total)

    Pizza lunch amount consumed will be measured

Sponsors and collaborators

Lead sponsor

Solae, LLC

Industry

Collaborators

  • Glycemic Index Laboratories, Inc

Registry information

Official study title

Effect of Addition of Soy Protein and Soy Fiber to a Snack Bar on Satiety and Food Intake

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 23, 2011
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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