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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01100788 |
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Date of registration:
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05/03/2010 |
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Primary sponsor: |
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Public title:
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Satiety Response of Short Chain Fructooligosaccharide
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Scientific title:
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Satiety Response of Short Chain Fructooligosaccharide |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01100788 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Joanne Slavin |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Minnesota - Clinical and Translational Science Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy men and women
- Age 18-64 years
- Non-smoking
- Not taking medication
- Non-dieting (weight stable in prior 3 months)
- BMI 18-27
- English literacy
Exclusion Criteria:
- Do not regularly consume breakfast
- Food allergies to ingredients found in study products
- BMI <18 or >27
- Diagnosed cardiovascular, renal, or hepatic disease diabetes mellitus
- Cancer in previous 5 years (except basal cell carcinoma of the skin)
- Any gastrointestinal disease or condition
- Recent bacterial infection (< 3 months)
- Recent or concurrent participation in an intervention research study
- History of drug or alcohol abuse in prior 6 months
- Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
- Eating disorder
- Vegetarians
- People who eat more than approximately 15 grams of fiber per day
- Women who are pregnant or lactating
- Women with irregular menstrual cycles
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Dietary Supplement: Short chain fructo-oligosaccharide (scFOS) 5 g
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Dietary Supplement: Short chain fructooligosaccharide (scFOS) 8 g
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Other: Placebo
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Primary Outcome(s)
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Satiety response using visual analogue scales
[Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially]
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Secondary Outcome(s)
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Ad libitum food intake
[Time Frame: 240 minutes postprandially and over 24 hours]
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Breath hydrogen response
[Time Frame: 0, 240 minutes]
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Gastrointestinal tolerance using visual analogue scales (VAS)
[Time Frame: 24 hours]
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Secondary ID(s)
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0806M37444
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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