Focus of the Study is on Gut HealthNCT01518088
Effects of a Dietary Fiber on Fecal Microbiota and Metabolism
A study testing Dietary Fiber in people with Focus of the Study is on Gut Health, run by Ingredion Incorporated at 1 site in United States.
Trial summary
The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is on Gut Health
- What is being tested?
- Dietary Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2013
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index from 25 to 35 kg/m2.
- Willing to consume study foods and comply with dietary exclusions and specimen collection
Who cannot join
- Pregnancy
- Diabetes
- Gastrointestinal disease
- Regular use of pre- or probiotics
- Recent use of antibiotics
- High intake of dietary fiber
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616
About this study
Official title: Effects of a Dietary Fiber on Human Gut Microbiota, Bioactive Metabolites and Blood Glucose Control
The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. In another three-week period, they will consume the same foods, but with no fiber added. Major outcomes will include fermentability of the fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The caloric value of the fiber will be determined and metabolic measures related to blood glucose control and inflammation will also be taken.
- Conditions
- Focus of the Study is on Gut Health
- Being tested
- Dietary Fiber
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary FiberDietary supplement
Dietary fiber will be added to study foods
| Study group | Role | What they receive |
|---|---|---|
| Low dose dietary fiber | Experimental | Not described Receives: Dietary Supplement: Dietary Fiber |
| High dose dietary fiber | Experimental | Not described Receives: Dietary Supplement: Dietary Fiber |
| No added fiber | Placebo comparator | Not described Receives: Dietary Supplement: Dietary Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolizable energy
Urine and feces will be collected for 7 days at the end of each treatment period to allow for assessment of metabolizable energy
Measured: 7 days, 3 times
Fermentability
Breath hydrogen will be measured hourly, over eight hours at the end of each treatment period
Measured: One, eight-hr day, three times
Secondary outcomes (2)
Fecal microbiota
Fecal samples will be collected for 7 days at the end of each treatment period and for two days during washout periods
Measured: 2 days, three times, and 7 days, three times
Blood glucose
An indwelling catheter will be placed and blood samples will be drawn over the course of an eight-hour period, at the end of each treatment period
Measured: For eight hours, three times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study is on Gut HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingredion Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Keim, PhD, Principal investigator, ARS/USDA, University of California - Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518088
- Sponsor's protocol ID
- PRT002
- Status last verified
- Jan 2012
- First submitted
- 20 Jan 2012
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Dietary Fiber on Human Gut Microbiota, Bioactive Metabolites and Blood Glucose Control
- ClinicalTrials.gov ID
- NCT01518088
- Acronym / sponsor ID
- PRT002
- Conditions
- Focus of the Study is on Gut Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ingredion IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jan 2012 (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 purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. In another three-week period, they will consume the same foods, but with no fiber added. Major outcomes will include fermentability of the fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The caloric value of the fiber will be determined and metabolic measures related to blood glucose control and inflammation will also be taken.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose dietary fiber | Experimental | Dietary Supplement: Dietary Fiber |
| High dose dietary fiber | Experimental | Dietary Supplement: Dietary Fiber |
| No added fiber | Placebo comparator | Dietary Supplement: Dietary Fiber |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index from 25 to 35 kg/m2.
- Willing to consume study foods and comply with dietary exclusions and specimen collection
Key exclusion criteria (6 listed)
- Pregnancy
- Diabetes
- Gastrointestinal disease
- Regular use of pre- or probiotics
- Recent use of antibiotics
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 |
|---|---|---|
| Dietary FiberDietary fiber will be added to study foods | Dietary supplement | High dose dietary fiber, Low dose dietary fiber, No added fiber |
Primary outcome
Metabolizable energy
Time frame: 7 days, 3 times
Urine and feces will be collected for 7 days at the end of each treatment period to allow for assessment of metabolizable energy
Fermentability
Time frame: One, eight-hr day, three times
Breath hydrogen will be measured hourly, over eight hours at the end of each treatment period
2 secondary outcomes
Fecal microbiota
Time frame: 2 days, three times, and 7 days, three times
Blood glucose
Time frame: For eight hours, three times
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 21 Apr 2016.
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.
Nancy Keim, PhD principal investigator
ARS/USDA, University of California - Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Fiber in people with Focus of the Study is on Gut Health, run by Ingredion Incorporated 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 2 inclusion and 6 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 21 Apr 2016. 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?
Metabolizable energy (time frame: 7 days, 3 times). The study lists 2 primary outcomes in all. 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 21 Apr 2016.