Status:
COMPLETED
The Effect of Fiber Snack Foods on Dietary Intake in Healthy Adults
Lead Sponsor:
University of Florida
Collaborating Sponsors:
General Mills
Conditions:
Fructooligosaccharide
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The proposed study will be a randomized, double-blind, parallel-arm study. Participants will incorporate snack foods (bar/yogurt) containing 16 grams of fiber (fructooligosaccharide) or similar snack ...
Detailed Description
The description of study activities is below: Screening Period (approximately 2 weeks before randomization): * Obtain height and weight * Complete a 10-question survey about fruit, vegetable, and fi...
Eligibility Criteria
Inclusion
- Adults 18 to 50 years of age
- Internet access for the duration of the protocol
- BMI of 23.0 to \< 30 kg/m2
- Usual fiber intake of \<20 g/d based on FFQ such as the Block Fruit/Vegetable/Fiber Screener
- Weight stable (±5 lbs. last 3 months)
- Assessment of normal eating determined by the Eating Inventory
- Willing to eat yogurt and a granola-like snack bar daily for 8 weeks
- Willing to complete daily questionnaires and 28 dietary recalls over the 8 weeks
- Habitual breakfast consumer defined as eating breakfast (any food within 2 hours of waking) 5 or more days a week
- Willing to provide a social security number to receive study payment
Exclusion
- Post-menopausal (self-reported no menstrual period for one year)
- Current smokers or tobacco users
- Based on Automated Self-Administered Diet History (ASA24) dietary intake data collected during pre-baseline period: Females eating less than 1200 kcal/day, males eating less than 1500 kcal/day or either or greater than 4000 kcal per day, consuming on average greater than 10 g dietary fiber/1000 kcal
- Unwilling to discontinue any prebiotic and fiber supplements, or probiotic supplement
- Antibiotic use within 2 months from study start
- Known food allergies
- Physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy other than GERD, constipation, diverticular disease)
- Taking prescribed medications other than oral contraceptives, seasonal allergy medications, cholesterol or blood pressure lowering medications, vitamins or minerals, baby aspirin
- Intake of \>2 alcoholic drinks per day on average
- Purposeful exercise of \>300 minutes per week on average
- Women who are lactating or know they are pregnant
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01478659
Start Date
August 1 2011
End Date
December 1 2011
Last Update
December 13 2012
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32611