HealthyNCT00958529
Gastrointestinal Toleration of Inulin Products
A study testing Inulin Fiber Supplement in people with Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
The intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products. The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inulin Fiber Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 2008
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- english speaking
- healthy men and women
- 18 and 60 years of age
- non-smoking
- non-dieting
- BMI less than 30
- standard diet consisting of no more than 15 grams fiber
- not taking medications
Who cannot join
- BMI more than 30
- CVD
- Diabetes Mellitus
- cancer in prior 5 years
- renal or hepatic disease
- bacterial infection in past 2 weeks
Show all 14Show fewer
- more than 5 kg weight loss in past 3 months
- history of drug or alcohol abuse in past 6 months
- use of weight loss, lipid-lowering, anti-hypertensive, or anti- inflammatory medications
- concurrent or recent intervention study participation
- consumption of laxatives
- history of gastrointestinal disorders
- food allergies
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota: Nutrition and Food Science Department
Minneapolis, Minnesota, 55108
About this study
Official title: Effect of Two Doses of Inulin Products on Gastrointestinal Tolerance
The intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products.
The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms.
Read the detailed description
0, 5, and 10 grams of inulin
- Conditions
- Healthy
- Being tested
- Inulin Fiber Supplement
- Keywords
- fiber, inulin, gastrointestinal tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin Fiber SupplementDietary supplement
Orange juice fortified with 0, 5g, and 10g of 2 inulin products
| Study group | Role | What they receive |
|---|---|---|
| inulin | Experimental | 0, 5, 10 g inulin Receives: Dietary Supplement: Inulin Fiber Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Tolerance Score
Measured: Aug 2008 thru Oct 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Sponsor
- Investigators
- Joanne L Slavin, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958529
- Sponsor's protocol ID
- 0805M32121
- Status last verified
- Feb 2017
- First submitted
- 12 Aug 2009
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Doses of Inulin Products on Gastrointestinal Tolerance
- ClinicalTrials.gov ID
- NCT00958529
- Acronym / sponsor ID
- 0805M32121
- Conditions
- Healthy
- Keywords
- fiber, inulin, gastrointestinal tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 13 Aug 2009 (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 intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products.
The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms.
Detailed description
0, 5, and 10 grams of inulin
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inulin | Experimental | Dietary Supplement: Inulin Fiber Supplement0, 5, 10 g inulin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- english speaking
- healthy men and women
- 18 and 60 years of age
- non-smoking
- non-dieting
Key exclusion criteria (14 listed)
- BMI more than 30
- CVD
- Diabetes Mellitus
- cancer in prior 5 years
- renal or hepatic disease
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 |
|---|---|---|
| Inulin Fiber SupplementOrange juice fortified with 0, 5g, and 10g of 2 inulin products | Dietary supplement | inulin |
Primary outcome
Gastrointestinal Tolerance Score
Time frame: Aug 2008 thru Oct 2008
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 10 Feb 2017.
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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.
Joanne L Slavin, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin Fiber Supplement in people with Healthy, run by University of Minnesota 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 8 inclusion and 14 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 10 Feb 2017. 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?
Gastrointestinal Tolerance Score (time frame: Aug 2008 thru Oct 2008). 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 10 Feb 2017.