Nutritional InterventionFCHONCT01497249
Assessing Fermentability of a Dietary Fiber
A study testing A dietary fiber (FCHO) in people with Nutritional Intervention, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The objective of this study is to provide evidence for its fermentability of a dietary fiber and to collect information regarding potential health opportunities for glucose control as well as tolerability when being consumed over 7 days. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Intervention
- What is being tested?
- A dietary fiber (FCHO)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2011to 28 Sep 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- BMI between 18.5 and 29.9 kg/m2, inclusive
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease
- No diabetes
- No Gastrointestinal issues
Who cannot join
- Pregnant and/or lactating or planning for pregnancy
- Allergies or intolerances to foods consumed in the study Fasting blood glucose > 125 mg/dL.
- Vegetarian
- Taking over the counter fiber supplements or other supplements that may interfere with the study procedures or endpoints
- Taking actively probiotics or purposely taking/ subscribing to a diet high in prebiotics.
- Taking prescription medications that may interfere with study procedures or endpoints (eg., antibiotics)
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- Subjects with unusual dietary habits (e.g. pica)
- Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period)
- Excessive exercisers or trained athletes
- Addicted to drugs and/or alcohol
- Medically documented psychiatric or neurological disturbances
- Smokers (past smokers may be allowed if cessation is > 2 years)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women
The objective of this study is to provide evidence for its fermentability of a dietary fiber and to collect information regarding potential health opportunities for glucose control as well as tolerability when being consumed over 7 days.
Read the detailed description
This study is designed as a randomized, 2-arm, treatment-controlled, within-subjects, 8-hour postprandial crossover study, utilizing a multiple sampling paradigm to evaluate fermentability and potential health opportunities for glucose control of a dietary fiber (FCHO) in healthy non-obese men and women. The study will include 2 - 8 h assessments following consumption of the FCHO drink or a placebo drink and will follow with a 7 day feeding period to assess tolerability.
- Conditions
- Nutritional Intervention
- Being tested
- A dietary fiber (FCHO), Placebo
- Keywords
- Dietary Fiber, Blood glucose control, Fermentability, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A dietary fiber (FCHO)Dietary supplement
Also called FCHO
15 g twice per day in beverage
PlaceboDietary supplement
Also called PCB
Placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Beverage Receives: Dietary Supplement: Placebo |
| A dietary fiber (FCHO) | Active comparator | 15g/BID Receives: Dietary Supplement: A dietary fiber (FCHO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women
FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions.
Hydrogen (H2) from breath will be measured before the breakfast test meal (baseline/fasting) and every hour: at 1hr, 2hr, 3hr, 4hr, 5hr, 6 hr, 7hr, and 8hr.
Measured: 8 hours
Secondary outcomes (2)
The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink
FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions.
Blood glucose will be measured before (fasting/baseline) and after breakfast test meal intake for 4hrs: 0, 30 min, 60 min, 120 min, and 240 min and then again after the light lunch meal at 30, 60, 90, 120 post lunch.
Measured: 8 hours
The tolerability of treatments over 7 days
After the in-lab study day (visit 1 and visit 2), subjects will go home with the test beverage packs to be consumed daily for 7 days. Subjects will maintain diaries to ensure daily consumption and on day 7 will be asked to complete a brief questionnaire related to gastrointestinal experiences during the week. Identical procedures will take place after both study days, except the assigned treatment will differ.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study start1 Dec 2011
- Primary completion28 Sep 2012
- Study completion28 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional InterventionStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ingredion Incorporated
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute for Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497249
- Sponsor's protocol ID
- FCHO 2011-086
- Acronym
- FCHO
- Status last verified
- Jul 2021
- First submitted
- 20 Dec 2011
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women
- ClinicalTrials.gov ID
- NCT01497249
- Acronym / sponsor ID
- FCHO / FCHO 2011-086
- Conditions
- Nutritional Intervention
- Keywords
- Dietary Fiber, Blood glucose control, Fermentability, Tolerability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Ingredion Incorporated
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 28 Sep 2012 (actual)
- Study completion
- 28 Sep 2012 (actual)
- First posted
- 22 Dec 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 objective of this study is to provide evidence for its fermentability of a dietary fiber and to collect information regarding potential health opportunities for glucose control as well as tolerability when being consumed over 7 days.
Detailed description
This study is designed as a randomized, 2-arm, treatment-controlled, within-subjects, 8-hour postprandial crossover study, utilizing a multiple sampling paradigm to evaluate fermentability and potential health opportunities for glucose control of a dietary fiber (FCHO) in healthy non-obese men and women. The study will include 2 - 8 h assessments following consumption of the FCHO drink or a placebo drink and will follow with a 7 day feeding period to assess tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo Beverage |
| A dietary fiber (FCHO) | Active comparator | Dietary Supplement: A dietary fiber (FCHO)15g/BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- BMI between 18.5 and 29.9 kg/m2, inclusive
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease
- No diabetes
- No Gastrointestinal issues
Key exclusion criteria (12 listed)
- Pregnant and/or lactating or planning for pregnancy
- Allergies or intolerances to foods consumed in the study Fasting blood glucose > 125 mg/dL.
- Vegetarian
- Taking over the counter fiber supplements or other supplements that may interfere with the study procedures or endpoints
- Taking actively probiotics or purposely taking/ subscribing to a diet high in prebiotics.
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 |
|---|---|---|
| A dietary fiber (FCHO)Also: FCHO15 g twice per day in beverage | Dietary supplement | A dietary fiber (FCHO) |
| PlaceboAlso: PCBPlacebo drink | Dietary supplement | Placebo |
Primary outcome
The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women
Time frame: 8 hours
FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions. Hydrogen (H2) from breath will be measured before the breakfast test meal (baseline/fasting) and every hour: at 1hr, 2hr, 3hr, 4hr, 5hr, 6 hr, 7hr, and 8hr.
2 secondary outcomes
The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink
Time frame: 8 hours
The tolerability of treatments over 7 days
Time frame: 7 days
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 27 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute for Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A dietary fiber (FCHO) in people with Nutritional Intervention, run by Clinical Nutrition Research Center, Illinois Institute of Technology 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 5 inclusion and 12 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 27 Jul 2021. 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?
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?
The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women (time frame: 8 hours). 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 27 Jul 2021.