Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-27 @ 2:21 AM
Study NCT ID:
NCT01478659
Status:
COMPLETED
Last Update Posted:
2012-12-13
First Post:
2011-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Fiber Snack Foods on Dietary Intake in Healthy Adults
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
The Effect of Fiber Snack Foods on Dietary Intake in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIB
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 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.
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: