Diet HabitFUELNCT05934357
Fiber's Utilization for Energy and Life
A study testing Fiber in people with Diet Habit, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The study aims to evaluate the metabolizable energy of the typical American diet with and without the inclusion of fiber. We hypothesize that including fiber in the diet will decrease the metabolizable energy of the diet resulting in more nutrient loss into the feces and urine. Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2023to May 2024
- 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 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ages 22-75 years
- BMI between 18.5 and 39.9 kg/m2
- Ability to drop-off 1 fecal sample within 15 minutes of defecation
- Ability to pick-up meals daily
- Ability to collect fecal and urine samples daily
- Fasting glucose of <126 mg/dL
Who cannot join
- Wheat allergy or intolerance
- Any food allergies or intolerances
- Prior diagnosis of metabolic or gastrointestinal disease (kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, diabetes requiring medication)
- Women that are pregnant, had a baby within the last 12 months, or are lactating.
- Individuals that smoke, use tobacco, abuse drugs, or consume > 2 alcoholic beverages per day.
- >5% weight change in the past month or >10% change in the past year
Show all 11Show fewer
- Oral antibiotics during the previous 6 weeks
- History of malabsorptive or restrictive bariatric surgeries (e.g., gastric bypass, sleeve gastrectomy, adjustable gastric band) or gall bladder removal surgery
- Are unable or unwilling to consume the experimental meals/snacks.
- Taking certain medications (Orlistat, bile binding resins, insulin, oral hypoglycemic agents, laxatives)
- Concurrent enrollment in another dietary, exercise, or medication study
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate the metabolizable energy of the typical American diet with and without the inclusion of fiber. We hypothesize that including fiber in the diet will decrease the metabolizable energy of the diet resulting in more nutrient loss into the feces and urine.
Read the detailed description
The study will be a randomized, crossover, controlled feeding trial comprised of 2 experimental periods: 1) control and 2) fiber. Each experimental condition will be 16 days in length. There will be at least a 12-day compliance break between each period. Participants will undergo complete urine and fecal collection for a period five to seven days during the second half of each experimental condition.
- Conditions
- Diet Habit
- Being tested
- Fiber, Control
- Keywords
- Fiber, Metabolizable Energy, Gastrointestinal Microbiota
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberOther
The intervention treatment will contain fiber.
ControlOther
The control treatment will contain corn meal.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Treatment | Experimental | Experimental treatment will contain a cereal product that contains a dietary fiber. This will be consumed three times daily for two weeks. Receives: Other: Fiber |
| Control treatment | Placebo comparator | Control treatment will contain a corn meal cereal product that will be consumed three times daily for two weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolizable Energy of the Diet
The diets provided to participants will be analyzed for their energy and proximate analysis. Fecal and urine samples will be collected for 5 days during week 2 of each intervention period to calculate the total metabolizable energy of the diet. Energy and proximate analysis (dry matter, organic matter, crude protein, acid-hydrolyzed fat, and total dietary fiber) will be analyzed from the provided diet and the fecal samples. Energy will be analyzed from urine samples. The metabolizable energy content will be calculated according to the methods of Novotny et al. (2012), which considers the energy of the diet compared to the remaining energy in the collected fecal and urine samples.
Measured: during the last 5 days of the 2 week intervention period
Secondary outcomes (1)
Fecal Microbiota
We will conduct qPCR to quantify total bacterial cells within one fresh fecal sample collected during week 2 of each condition.
Measured: end of week 2 (end of intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start13 May 2023
- Primary completionDec 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934357
- Sponsor's protocol ID
- 24042
- Acronym
- FUEL
- Status last verified
- Dec 2023
- First submitted
- 16 May 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber's Utilization for Energy and Life
- ClinicalTrials.gov ID
- NCT05934357
- Acronym / sponsor ID
- FUEL / 24042
- Conditions
- Diet Habit
- Keywords
- Fiber, Metabolizable Energy, Gastrointestinal Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 13 May 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 6 Jul 2023 (actual)
- 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 study aims to evaluate the metabolizable energy of the typical American diet with and without the inclusion of fiber. We hypothesize that including fiber in the diet will decrease the metabolizable energy of the diet resulting in more nutrient loss into the feces and urine.
Detailed description
The study will be a randomized, crossover, controlled feeding trial comprised of 2 experimental periods: 1) control and 2) fiber. Each experimental condition will be 16 days in length. There will be at least a 12-day compliance break between each period. Participants will undergo complete urine and fecal collection for a period five to seven days during the second half of each experimental condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Treatment | Experimental | Other: FiberExperimental treatment will contain a cereal product that contains a dietary fiber. This will be consumed three times daily for two weeks. |
| Control treatment | Placebo comparator | Other: ControlControl treatment will contain a corn meal cereal product that will be consumed three times daily for two weeks. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ages 22-75 years
- BMI between 18.5 and 39.9 kg/m2
- Ability to drop-off 1 fecal sample within 15 minutes of defecation
- Ability to pick-up meals daily
- Ability to collect fecal and urine samples daily
Key exclusion criteria (11 listed)
- Wheat allergy or intolerance
- Any food allergies or intolerances
- Prior diagnosis of metabolic or gastrointestinal disease (kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, diabetes requiring medication)
- Women that are pregnant, had a baby within the last 12 months, or are lactating.
- Individuals that smoke, use tobacco, abuse drugs, or consume > 2 alcoholic beverages per day.
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 |
|---|---|---|
| FiberThe intervention treatment will contain fiber. | Other | Intervention Treatment |
| ControlThe control treatment will contain corn meal. | Other | Control treatment |
Primary outcome
Metabolizable Energy of the Diet
Time frame: during the last 5 days of the 2 week intervention period
The diets provided to participants will be analyzed for their energy and proximate analysis. Fecal and urine samples will be collected for 5 days during week 2 of each intervention period to calculate the total metabolizable energy of the diet. Energy and proximate analysis (dry matter, organic matter, crude protein, acid-hydrolyzed fat, and total dietary fiber) will be analyzed from the provided diet and the fecal samples. Energy will be analyzed from urine samples. The metabolizable energy content will be calculated according to the methods of Novotny et al. (2012), which considers the energy of the diet compared to the remaining energy in the collected fecal and urine samples.
1 secondary outcome
Fecal Microbiota
Time frame: end of week 2 (end of intervention period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber in people with Diet Habit, run by University of Illinois at Urbana-Champaign 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 6 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Metabolizable Energy of the Diet (time frame: during the last 5 days of the 2 week intervention period). 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 6 Dec 2023.