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

This study has been completed.
Sponsor:
Collaborator:
General Mills Inc.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01478659
First received: November 2, 2011
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Fructooligosaccharide
Dietary Supplement: Control study food with no added fiber
Dietary Supplement: Study food with added fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect of Fiber Snack Foods on Dietary Intake in Healthy Adults

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in pre-baseline and final average dietary intake [ Time Frame: Pre-baseline Week and Week 8 ] [ Designated as safety issue: No ]
    All participants will complete 24-hour online diet recalls during pre-baseline, week 4, 6 and 8 in order to determine if the addition of 16 g of fiber incorporated into snack bars and yogurt to the usual diets of mildly to moderately overweight adults results in reduced habitual energy intake compared to the addition of snack bars and yogurt without fiber.


Secondary Outcome Measures:
  • Change in anthropometrics from pre-baseline to week 8: height, weight, BMI, and body composition [ Time Frame: Pre-baseline and final (week 8) ] [ Designated as safety issue: No ]
    All participants will have anthropometics measured at pre-baseline and again at the end of the study in order to determine if the addition of 16 g of fiber incorporated into snack bars and yogurt to the usual diets of mildly to moderately overweight adults results in reduced body weight and/or alter body composition compared to the addition of snack bars and yogurt without fiber.

  • Change in nutrient intakes from online diet recall program from pre-baseline to week 8 [ Time Frame: Pre-baseline, Week 2, Week 4, and Week 8 ] [ Designated as safety issue: No ]
    All participants will complete 24-hour online diet recalls during pre-baseline, week 4, week 6, and week 8 in order to determine if the addition of 16 g of fiber incorporated into snack bars and yogurt to the usual diets of mildly to moderately overweight adults alters macronutrient and micronutrients content within the diet compared to the addition of snack bars/yogurt without fiber.


Enrollment: 97
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control bar and yogurt Dietary Supplement: Control study food with no added fiber
Adults consuming their usual diet modified by incorporating yogurt and snack bars without added fiber.
Experimental: Fiber bar and yogurt Dietary Supplement: Study food with added fiber
Adults consuming their usual diet modified by incorporating yogurt and snack bars containing 16 g of chicory root fiber (Frutalose®).

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 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
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478659

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
General Mills Inc.
Investigators
Principal Investigator: Wendy Dahl, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01478659     History of Changes
Other Study ID Numbers: FIB
Study First Received: November 2, 2011
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Diet
Fiber
Adult
Fructooligosaccharide

ClinicalTrials.gov processed this record on November 24, 2014