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

University of Florida

Status

Completed

Conditions

Fructooligosaccharide

Treatments

Dietary Supplement: Study food with added fiber

Dietary Supplement: Control study food with no added fiber

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01478659

FIB

Details and patient eligibility

About

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.

Full 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 fiber intake
Receive training on how to complete daily questionnaires online
Complete the Global Physical Activity Questionnaire. This is a 16-question survey asking about physical activity in a typical week
Complete the Eating Inventory. This is a 51-question survey that asks about your dietary habits and feelings related to food and eating
Receive training on how to record your dietary intake using the ASA24. The ASA24 is a web-based interactive program that asks you to record the foods you ate during the previous day

Randomization:

Measure weight, waist circumference, and body composition. We will use the BodPod to measure your body composition. The BodPod uses air displacement to measure body volume
Receive dietary counseling on how to incorporate the study foods into your current diet. You will be asked to use these foods to replace foods you are currently eating
Consume one study food per day for the first week and then 2 foods per day for weeks 2 through 8.
Complete the 10-question online daily survey
Complete 7 days of 24-hour dietary recalls using the ASA24 during weeks 4, 6, and 8

Final:

Return any uneaten study foods.
Measure weight, waist circumference, and body composition
Complete the Global Physical Activity Questionnaire (GPAQ) and the Eating Inventory

Enrollment

97 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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