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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: |
NCT01233024 |
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Date of registration:
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28/05/2010 |
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Primary sponsor: |
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Public title:
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Satiety Response of Four Dietary Fibers
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Scientific title:
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Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation |
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Date of first enrolment:
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November 2010 |
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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/NCT01233024 |
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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, Outcomes Assessor), 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 L Slavin, PhD |
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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 women
- Age 18-40 years
- Nonsmoking
- Not taking weight loss medications
- Non-dieting (weight has not changed more than 11 pounds over three months)
- BMI between 18.5 and 29
- Spoken and written English literacy
Exclusion Criteria:
- Do not regularly consume breakfast
- Food allergies to wheat, soy, peanut, or dairy
- BMI less than 25 or greater than 29 upon admission to study
- Cancer diagnosis in past 5 years
- History of heart disease, kidney disease, diabetes, or eating disorder
- History of ulcerative colitis, Crohn's disease, or any other gastrointestinal
condition
- History of drug or alcohol abuse in past 6 months
- Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
- Concurrent or recent (within 30 days) intervention study participation
- Pregnant or lactating
- Irregular menstrual cycle
- Vegetarians
- People who eat more than approximately 15 grams of fiber per day
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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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: Control
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Dietary Supplement: Fructooligosaccharide
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Dietary Supplement: Inulin
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Dietary Supplement: Resistant starch
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Dietary Supplement: Soluble corn fiber
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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 minutes postprandially]
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Secondary Outcome(s)
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Breath hydrogen response
[Time Frame: 0 and 180 minutes]
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Food intake
[Time Frame: 180 minutes postprandially and over 24 hours]
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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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1003E78714
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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