Focus of the Study is Insulin SensitivityNCT01521806
Effects of Dietary Fiber on Insulin Sensitivity
A study testing Dietary Fiber in people with Focus of the Study is Insulin Sensitivity, run by Ingredion Incorporated at 1 site in United States.
Trial summary
This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in another period. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is Insulin Sensitivity
- What is being tested?
- Dietary Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 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 19 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Impaired fasting glucose
- Overweight and obese
Who cannot join
- Diabetes, Presence of chronic diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Unit
Birmingham, Alabama, 35249
Brandon Kane, 205-975-9629, kane003@uab.edu
Barbara Gower, PhD
About this study
Official title: Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women
This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in another period. In a third period, no fiber will be added to the snack foods. Insulin senstivity will be measured at the end of each treatment period.
- Being tested
- Dietary Fiber
- Keywords
- insulin sensitivity, resistant starch
- Medical subject headings
- Insulin Resistance
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 snack foods
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 15 g of fiber per day will be added to snack foods Receives: Dietary Supplement: Dietary Fiber |
| High dose | Experimental | 30 g of fiber per day will be added to snack foods Receives: Dietary Supplement: Dietary Fiber |
| No fiber | Placebo comparator | Snack foods without fiber will be given Receives: Dietary Supplement: Dietary Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
A frequently sampled intravenous blood glucose tolerance test will be performed.
Measured: 5-hr test, performed 3 times within a 20-week period
Secondary outcomes (2)
Mitocondrial function
A muscle biospy will be taken to assess mitochondrial function
Measured: 3 times, with a 20-week period
Meal tolerance test
A high-fat meal will be given and blood will be drawn over a three-hr period
Measured: 3 times, within a 20-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2012 (estimated)
- Study completionSep 2013 (estimated)
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 Insulin SensitivityStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ingredion Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Gower, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521806
- Sponsor's protocol ID
- HM001
- Status last verified
- Jan 2012
- First submitted
- 20 Jan 2012
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women
- ClinicalTrials.gov ID
- NCT01521806
- Acronym / sponsor ID
- HM001
- Keywords
- insulin sensitivity, resistant starch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ingredion IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 31 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.
This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in another period. In a third period, no fiber will be added to the snack foods. Insulin senstivity will be measured at the end of each treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Dietary Supplement: Dietary Fiber15 g of fiber per day will be added to snack foods |
| High dose | Experimental | Dietary Supplement: Dietary Fiber30 g of fiber per day will be added to snack foods |
| No fiber | Placebo comparator | Dietary Supplement: Dietary FiberSnack foods without fiber will be given |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Impaired fasting glucose
- Overweight and obese
Key exclusion criteria (1 listed)
- Diabetes, Presence of chronic diseases
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 snack foods | Dietary supplement | High dose, Low dose, No fiber |
Primary outcome
Insulin sensitivity
Time frame: 5-hr test, performed 3 times within a 20-week period
A frequently sampled intravenous blood glucose tolerance test will be performed.
2 secondary outcomes
Mitocondrial function
Time frame: 3 times, with a 20-week period
Meal tolerance test
Time frame: 3 times, within a 20-week period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
- clinical centerLink provided by the sponsor.
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.
Barbara Gower, PhD principal investigator
University of Alabama at Birmingham
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 Insulin Sensitivity, 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 1 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 31 Jan 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. 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?
Contact Brandon Kane (205-975-9629, kane003@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 5-hr test, performed 3 times within a 20-week 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 31 Jan 2012.