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| Name | Class |
|---|---|
| General Mills | INDUSTRY |
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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.
The description of study activities is below:
Screening Period (approximately 2 weeks before randomization):
Randomization:
Final:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control bar and yogurt | Active Comparator |
| |
| Fiber bar and yogurt | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control study food with no added fiber | Dietary Supplement | Adults consuming their usual diet modified by incorporating yogurt and snack bars without added fiber. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pre-baseline and final average dietary intake | 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. | Pre-baseline Week and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anthropometrics from pre-baseline to week 8: height, weight, BMI, and body composition | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Dahl, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
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| Study food with added fiber | Dietary Supplement | Adults consuming their usual diet modified by incorporating yogurt and snack bars containing 16 g of chicory root fiber (Frutalose®). |
|
| Pre-baseline and final (week 8) |
| Change in nutrient intakes from online diet recall program from pre-baseline to week 8 | 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. | Pre-baseline, Week 2, Week 4, and Week 8 |