FructooligosaccharideFIBNCT01478659
The Effect of Fiber Snack Foods on Dietary Intake in Healthy Adults
A study testing Study food with added fiber in people with Fructooligosaccharide, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fructooligosaccharide
- What is being tested?
- Study food with added fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Fructooligosaccharide
- Being tested
- Control study food with no added fiber, Study food with added fiber
- Keywords
- Diet, Fiber, Adult, Fructooligosaccharide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control study food with no added fiberDietary supplement
Adults consuming their usual diet modified by incorporating yogurt and snack bars without added fiber.
Study food with added fiberDietary supplement
Adults consuming their usual diet modified by incorporating yogurt and snack bars containing 16 g of chicory root fiber (Frutalose®).
| Study group | Role | What they receive |
|---|---|---|
| Control bar and yogurt | Active comparator | Not described Receives: Dietary Supplement: Control study food with no added fiber |
| Fiber bar and yogurt | Experimental | Not described Receives: Dietary Supplement: Study food with added fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-baseline Week and Week 8
Secondary outcomes (2)
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.
Measured: 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.
Measured: Pre-baseline, Week 2, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FructooligosaccharideStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- General Mills
- Responsible party
- Sponsor
- Investigators
- Wendy Dahl, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478659
- Sponsor's protocol ID
- FIB
- Acronym
- FIB
- Status last verified
- Dec 2012
- First submitted
- 2 Nov 2011
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fiber Snack Foods on Dietary Intake in Healthy Adults
- ClinicalTrials.gov ID
- NCT01478659
- Acronym / sponsor ID
- FIB / FIB
- Conditions
- Fructooligosaccharide
- Keywords
- Diet, Fiber, Adult, Fructooligosaccharide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- General Mills
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control bar and yogurt | Active comparator | Dietary Supplement: Control study food with no added fiber |
| Fiber bar and yogurt | Experimental | Dietary Supplement: Study food with added fiber |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control study food with no added fiberAdults consuming their usual diet modified by incorporating yogurt and snack bars without added fiber. | Dietary supplement | Control bar and yogurt |
| Study food with added fiberAdults consuming their usual diet modified by incorporating yogurt and snack bars containing 16 g of chicory root fiber (Frutalose®). | Dietary supplement | Fiber bar and yogurt |
Primary outcome
Change in pre-baseline and final average dietary intake
Time frame: Pre-baseline Week and Week 8
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.
2 secondary outcomes
Change in anthropometrics from pre-baseline to week 8: height, weight, BMI, and body composition
Time frame: Pre-baseline and final (week 8)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
Related trials for Fructooligosaccharide
Recruiting
Dietary Fibres on Gut Fermentation
Healthy Adult
Not yet recruiting
Enzymax DuoBiotics for Irritable Bowel Syndrome
Irritable Bowel Syndrome, Irritable Bowel Syndrome (IBS)
Active, not recruiting
Effect of Dietary Carbohydrate Content and Inulin-Fructooligosaccharide Supplementation on Glycemic Control in Individuals With Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus
Recruiting
Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial
Constipation - Functional
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Dahl, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study food with added fiber in people with Fructooligosaccharide, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pre-baseline and final average dietary intake (time frame: Pre-baseline Week and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2012.