ObesityNCT02562014
Role of Colonic Short Chain Fatty Acids in Obesity
A study testing Glucose, Inulin and Resistant Starch in people with Obesity, run by University of Toronto.
Trial summary
The excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role in preventing diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Glucose, Inulin and Resistant Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jan 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non-pregnant
- body mass index >=20 and <=35
Who cannot join
- history of diabetes mellitus
- history of cardiovascular disease
- history of bowel disease
- history of kidney disease
- history of liver disease
- use of antibiotics within 3 months of enrolment
Show all 9Show fewer
- unusual dietary habits
- fasting glucose >6.9mmol/L
- hematocrit below normal range for age and sex
About this study
Official title: Effect of Inulin and Resistant Starch on Postprandial Short Chain Fatty Acid, Glucose, Insulin and Gut Hormone Responses in Lean and Overweight Subjects.
The excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role in preventing diabetes. The investigators aimed to compare the effects of two fermentable fibers (inulin and resistant-starch) on postprandial SCFA, glucose, insulin, free-fatty acids (FFA) and gut hormone responses and to compare the responses in healthy overweight and obese (OWO) vs lean (LN) participants. Methods: Using a randomized, single blind, crossover design, 13 OWO and 12 LN overnight fasted participants were studied on 3 separate occasions. On each day they consumed a 300 mL drink containing 75g glucose (Control) or 75g glucose plus 24g inulin (IN), or 28.2g resistant-starch (RS). A standard lunch was served 4 h after the test drink.
- Conditions
- Obesity
- Being tested
- Glucose, Inulin, Resistant Starch
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseOther
75g glucose
InulinOther
75g glucose plus 24g inulin
Resistant StarchOther
75g glucose plus 28.2g resistant starch
| Study group | Role | What they receive |
|---|---|---|
| Lean | Other | Participants with body mass index <=25 Receives: Other: Glucose; Other: Inulin; Other: Resistant Starch |
| Overweight | Other | Participants with body mass index >25 Receives: Other: Glucose; Other: Inulin; Other: Resistant Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the serum acetate response curve
Measured: For 6 hours after consuming the test meal
Secondary outcomes (12)
Incremental area under the serum propionate response curve
Measured: For 6 hours after consuming the test meal
Incremental area under the serum butyrate response curve
Measured: For 6 hours after consuming the test meal
Incremental area under the breath hydrogen response curve
Measured: For 6 hours after consuming the test meal
Incremental area under the breath methane response curve
Measured: For 6 hours after consuming the test meal
Incremental area under the serum glucose response curve
Measured: For 4 hours after consuming the test meal
Incremental area under the serum glucose response curve
Measured: For 2 hours after consuming the standard lunch
Incremental area under the serum insulin response curve
Measured: For 4 hours after consuming the test meal
Incremental area under the serum insulin response curve
Measured: For 2 hours after consuming the standard lunch
Incremental area under the serum c-peptide response curve
Measured: For 4 hours after consuming the test meal
Incremental area under the serum c-peptide response curve
Measured: For 2 hours after consuming the standard lunch
Total area under the serum free-fatty acid response curve
Measured: For 4 hours after consuming the test meal
Total area under the serum free-fatty acid response curve
Measured: For 2 hours after consuming the standard lunch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Wolever, University of Toronto
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562014
- Sponsor's protocol ID
- Protocol #27112
- Status last verified
- Sep 2015
- First submitted
- 25 Sep 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rahat-Rozenbloom S, Fernandes J, Cheng J, Wolever TMS. Acute increases in serum colonic short-chain fatty acids elicited by inulin do not increase GLP-1 or PYY responses but may reduce ghrelin in lean and overweight humans. Eur J Clin Nutr. 2017 Aug;71(8):953-958. doi: 10.1038/ejcn.2016.249. Epub 2016 Dec 14.
PubMed 27966574Rahat-Rozenbloom S, Fernandes J, Cheng J, Gloor GB, Wolever TM. The acute effects of inulin and resistant starch on postprandial serum short-chain fatty acids and second-meal glycemic response in lean and overweight humans. Eur J Clin Nutr. 2017 Feb;71(2):227-233. doi: 10.1038/ejcn.2016.248. Epub 2016 Dec 14.
PubMed 27966565
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inulin and Resistant Starch on Postprandial Short Chain Fatty Acid, Glucose, Insulin and Gut Hormone Responses in Lean and Overweight Subjects.
- ClinicalTrials.gov ID
- NCT02562014
- Acronym / sponsor ID
- Protocol #27112
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Sep 2015 (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 excess production of colonic short-chain-fatty-acids (SCFA) has been implicated in the promotion of obesity, but colonic fermentation of dietary-fiber to SCFA may also play a role in preventing diabetes. The investigators aimed to compare the effects of two fermentable fibers (inulin and resistant-starch) on postprandial SCFA, glucose, insulin, free-fatty acids (FFA) and gut hormone responses and to compare the responses in healthy overweight and obese (OWO) vs lean (LN) participants. Methods: Using a randomized, single blind, crossover design, 13 OWO and 12 LN overnight fasted participants were studied on 3 separate occasions. On each day they consumed a 300 mL drink containing 75g glucose (Control) or 75g glucose plus 24g inulin (IN), or 28.2g resistant-starch (RS). A standard lunch was served 4 h after the test drink.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean | Other | Other: Glucose, Other: Inulin, Other: Resistant StarchParticipants with body mass index <=25 |
| Overweight | Other | Other: Glucose, Other: Inulin, Other: Resistant StarchParticipants with body mass index >25 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- non-pregnant
- body mass index >=20 and <=35
Key exclusion criteria (9 listed)
- history of diabetes mellitus
- history of cardiovascular disease
- history of bowel disease
- history of kidney disease
- history of liver 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 |
|---|---|---|
| Glucose75g glucose | Other | Lean, Overweight |
| Inulin75g glucose plus 24g inulin | Other | Lean, Overweight |
| Resistant Starch75g glucose plus 28.2g resistant starch | Other | Lean, Overweight |
Primary outcome
Incremental area under the serum acetate response curve
Time frame: For 6 hours after consuming the test meal
12 secondary outcomes
Incremental area under the serum propionate response curve
Time frame: For 6 hours after consuming the test meal
Incremental area under the serum butyrate response curve
Time frame: For 6 hours after consuming the test meal
Incremental area under the breath hydrogen response curve
Time frame: For 6 hours after consuming the test meal
Incremental area under the breath methane response curve
Time frame: For 6 hours after consuming the test meal
Incremental area under the serum glucose response curve
Time frame: For 4 hours after consuming the test meal
Incremental area under the serum glucose response curve
Time frame: For 2 hours after consuming the standard lunch
Incremental area under the serum insulin response curve
Time frame: For 4 hours after consuming the test meal
Incremental area under the serum insulin response curve
Time frame: For 2 hours after consuming the standard lunch
Incremental area under the serum c-peptide response curve
Time frame: For 4 hours after consuming the test meal
Incremental area under the serum c-peptide response curve
Time frame: For 2 hours after consuming the standard lunch
Total area under the serum free-fatty acid response curve
Time frame: For 4 hours after consuming the test meal
Total area under the serum free-fatty acid response curve
Time frame: For 2 hours after consuming the standard lunch
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 29 Sep 2015.
- Derived from this study: PubMed 27966574Rahat-Rozenbloom S, Fernandes J, Cheng J, Wolever TMS. Acute increases in serum colonic short-chain fatty acids elicited by inulin do not increase GLP-1 or PYY responses but may reduce ghrelin in lean and overweight humans. Eur J Clin Nutr. 2017 Aug;71(8):953-958. doi: 10.1038/ejcn.2016.249. Epub 2016 Dec 14.
- Derived from this study: PubMed 27966565Rahat-Rozenbloom S, Fernandes J, Cheng J, Gloor GB, Wolever TM. The acute effects of inulin and resistant starch on postprandial serum short-chain fatty acids and second-meal glycemic response in lean and overweight humans. Eur J Clin Nutr. 2017 Feb;71(2):227-233. doi: 10.1038/ejcn.2016.248. Epub 2016 Dec 14.
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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.
Thomas MS Wolever, MD, PhD principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Glucose, Inulin and Resistant Starch in people with Obesity, run by University of Toronto.
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 9 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 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Incremental area under the serum acetate response curve (time frame: For 6 hours after consuming the test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02562014, which also lists 2 linked publications.
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 29 Sep 2015.