Insulin ResistanceBROWNIENCT01830686
Metabolic Effects of Short Term Sugarcane Bagasse Supplementation
A study testing Sugarcane bagasse, Non-caloric, non-fermentable fiber and Minimal fiber in people with Insulin Resistance, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to help understand the benefits of eating food supplemented with fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on glucose metabolism and body weight. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Sugarcane bagasse, Non-caloric, non-fermentable fiber and Minimal fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2014
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females age 18-50 years
- Body Mass Index ≥ 30 kg/m2 (a ratio of weight to height)
- Fasting insulin level >5 µIU/mL, as determined by tests performed during screening
Who cannot join
- Women who are pregnant
- Past medical history of diabetes
- History of intestinal surgery such as removal of bowel
- History of problems with absorbing food such as celiac disease, inflammatory bowel disease, malabsorption syndrome
- Taking chronic medications for any medical conditions such as diabetes, hypertension, cholesterol, thyroid hormone, etc.
- Any food allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The purpose of this study is to help understand the benefits of eating food supplemented with fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on glucose metabolism and body weight.
Read the detailed description
The investigators will employ a double-blind randomized controlled study design with 3 arms such that obese, insulin resistant adults will be randomly selected to receive food made with 1) sugarcane bagasse, 2) non-caloric, non-fermentable fiber, or 3) a similar product with minimal fiber for 4 weeks. The intervention will be in the form of brownies and cookies and will look and taste nearly identical to each other. Caloric value will be constant with all three delivery systems. Subjects will have blood testing and body composition analysis before and after the intervention.
- Conditions
- Insulin Resistance
- Being tested
- Sugarcane bagasse, Non-caloric, non-fermentable fiber, Minimal fiber
- Keywords
- Sugarcane bagasse, glucose tolerance, insulin resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugarcane bagasseOther
One brownie containing 10 g of sugarcane bagasse and 2 cookies containing 3 g of sugarcane bagasse (total of 13 g of sugarcane bagasse per day)
Non-caloric, non-fermentable fiberOther
One brownie containing 10 g of fiber and 2 cookies containing 3 g of fiber (total of 13 g of non-caloric, non-fermentable fiber per day)
Minimal fiberOther
One brownie containing 3g of fiber and two cookies containing 1g of fiber (total of 4 g of dietary fiber per day)
| Study group | Role | What they receive |
|---|---|---|
| Sugarcane bagasse | Experimental | 10 subjects will consume food (brownies and cookies) made with 13 g of sugarcane bagasse everyday for 4 weeks Receives: Other: Sugarcane bagasse |
| Non-caloric, non-fermentable fiber | Active comparator | 10 subjects will consume food (brownies and cookies) made with 13 g of non caloric, non-fermentable fiber everyday for 4 weeks Receives: Other: Non-caloric, non-fermentable fiber |
| Minimal fiber | Placebo comparator | 10 subjects will consume food (brownies and cookies) made with 4 g of dietary fiber everyday for 4 weeks Receives: Other: Minimal fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance
Participants will be randomly selected to eat food supplemented with either 1) sugarcane bagasse, 2) another type of fiber of equal weight, or 3) minimal fiber. At baseline each eligible subject will have a 3 hour oral glucose tolerance test. Subjects will consume one brownie and two cookies a day for four weeks. At the end of four weeks, the blood tests conducted at baseline will be repeated.
Measured: 4 weeks
Secondary outcomes (1)
The effect of sugarcane bagasse on body weight/composition
At baseline and weekly till the end of the study, weight will be measured. In addition body composition via DXA will be measured at baseline and at the end of the study.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Hsia, Pennington Biomedical Research Center
- Investigators
- Daniel Hsia, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830686
- Sponsor's protocol ID
- PBRC 13005
- Acronym
- BROWNIE
- Status last verified
- Feb 2016
- First submitted
- 10 Apr 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Short Term Sugarcane Bagasse Supplementation
- ClinicalTrials.gov ID
- NCT01830686
- Acronym / sponsor ID
- BROWNIE / PBRC 13005
- Conditions
- Insulin Resistance
- Keywords
- Sugarcane bagasse, glucose tolerance, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Apr 2013 (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 this study is to help understand the benefits of eating food supplemented with fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on glucose metabolism and body weight.
Detailed description
The investigators will employ a double-blind randomized controlled study design with 3 arms such that obese, insulin resistant adults will be randomly selected to receive food made with 1) sugarcane bagasse, 2) non-caloric, non-fermentable fiber, or 3) a similar product with minimal fiber for 4 weeks. The intervention will be in the form of brownies and cookies and will look and taste nearly identical to each other. Caloric value will be constant with all three delivery systems. Subjects will have blood testing and body composition analysis before and after the intervention.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugarcane bagasse | Experimental | Other: Sugarcane bagasse10 subjects will consume food (brownies and cookies) made with 13 g of sugarcane bagasse everyday for 4 weeks |
| Non-caloric, non-fermentable fiber | Active comparator | Other: Non-caloric, non-fermentable fiber10 subjects will consume food (brownies and cookies) made with 13 g of non caloric, non-fermentable fiber everyday for 4 weeks |
| Minimal fiber | Placebo comparator | Other: Minimal fiber10 subjects will consume food (brownies and cookies) made with 4 g of dietary fiber everyday for 4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females age 18-50 years
- Body Mass Index ≥ 30 kg/m2 (a ratio of weight to height)
- Fasting insulin level >5 µIU/mL, as determined by tests performed during screening
Key exclusion criteria (6 listed)
- Women who are pregnant
- Past medical history of diabetes
- History of intestinal surgery such as removal of bowel
- History of problems with absorbing food such as celiac disease, inflammatory bowel disease, malabsorption syndrome
- Taking chronic medications for any medical conditions such as diabetes, hypertension, cholesterol, thyroid hormone, etc.
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 |
|---|---|---|
| Sugarcane bagasseOne brownie containing 10 g of sugarcane bagasse and 2 cookies containing 3 g of sugarcane bagasse (total of 13 g of sugarcane bagasse per day) | Other | Sugarcane bagasse |
| Non-caloric, non-fermentable fiberOne brownie containing 10 g of fiber and 2 cookies containing 3 g of fiber (total of 13 g of non-caloric, non-fermentable fiber per day) | Other | Non-caloric, non-fermentable fiber |
| Minimal fiberOne brownie containing 3g of fiber and two cookies containing 1g of fiber (total of 4 g of dietary fiber per day) | Other | Minimal fiber |
Primary outcome
The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance
Time frame: 4 weeks
Participants will be randomly selected to eat food supplemented with either 1) sugarcane bagasse, 2) another type of fiber of equal weight, or 3) minimal fiber. At baseline each eligible subject will have a 3 hour oral glucose tolerance test. Subjects will consume one brownie and two cookies a day for four weeks. At the end of four weeks, the blood tests conducted at baseline will be repeated.
1 secondary outcome
The effect of sugarcane bagasse on body weight/composition
Time frame: 4 weeks
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 3 Feb 2016.
- 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.
Daniel Hsia, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugarcane bagasse, Non-caloric, non-fermentable fiber and Minimal fiber in people with Insulin Resistance, run by Pennington Biomedical Research Center 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 3 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 3 Feb 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?
The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance (time frame: 4 weeks). 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 3 Feb 2016.