The Effect of Fiber Snack Foods on Dietary Intake in Healthy Adults

Completed · Not applicable

Conditions studied: Fructooligosaccharide

In brief

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 foods without the added fiber into their usual diets. The study period will include a 2-week pre-baseline assessment period and an 8-week treatment period. During the 2-week pre-baseline period no study foods will be consumed however dietary intake will be assessed using a 24-hour online diet recall program. The first week of the 8-week treatment will serve as an acclimation period where only one serving of the study foods will be given (8 grams of fiber) per day. Participants will receive two servings (16 grams of fiber) per day for weeks 2 through 8 of the treatment period and 24-hour online diet recalls will be completed during weeks 4, 6 and 8. Hypothesis: Adults aged 18 to 50 years consuming their usual diet modified by incorporating yogurt and snack bars containing 16 grams of chicory root fiber (Frutalose®) will decrease their usual dietary intake to a greater extent compared to participants who receive similar snack foods without the added fiber.

Key facts

Study ID

NCT01478659

Run by

University of Florida

People needed

97

Starts

2011-08-01

Expected to finish

2011-12-01

Last updated by the study team

2012-12-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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