Clinical trial NCT02562014: Role of Colonic Short Chain Fatty Acids in Obesity
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* non-pregnant
* body mass index \>=20 and \<=35

Exclusion Criteria:

* 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
* unusual dietary habits
* fasting glucose \>6.9mmol/L
* hematocrit below normal range for age and sex

Primary outcomes:
measure: Incremental area under the serum acetate response curve
timeFrame: For 6 hours after consuming the test meal
Secondary outcomes:
measure: Incremental area under the serum propionate response curve
timeFrame: For 6 hours after consuming the test meal
measure: Incremental area under the serum butyrate response curve
timeFrame: For 6 hours after consuming the test meal
measure: Incremental area under the breath hydrogen response curve
timeFrame: For 6 hours after consuming the test meal
measure: Incremental area under the breath methane response curve
timeFrame: For 6 hours after consuming the test meal
measure: Incremental area under the serum glucose response curve
timeFrame: For 4 hours after consuming the test meal
measure: Incremental area under the serum glucose response curve
timeFrame: For 2 hours after consuming the standard lunch
measure: Incremental area under the serum insulin response curve
timeFrame: For 4 hours after consuming the test meal
measure: Incremental area under the serum insulin response curve
timeFrame: For 2 hours after consuming the standard lunch
measure: Incremental area under the serum c-peptide response curve
timeFrame: For 4 hours after consuming the test meal
measure: Incremental area under the serum c-peptide response curve
timeFrame: For 2 hours after consuming the standard lunch
measure: Total area under the serum free-fatty acid response curve
timeFrame: For 4 hours after consuming the test meal
measure: Total area under the serum free-fatty acid response curve
timeFrame: For 2 hours after consuming the standard lunch
Other outcomes:
measure: Incremental area under the serum glucagon-like peptide-1 response curve
timeFrame: For 4 hours after consuming the test meal
measure: Incremental area under the serum glucagon-like peptide-1 response curve
timeFrame: For 2 hours after consuming the standard lunch
measure: Incremental area under the serum peptide-YY response curve
timeFrame: For 4 hours after consuming the test meal
measure: Incremental area under the serum peptide-YY response curve
timeFrame: For 2 hours after consuming the standard lunch
measure: Incremental area under the serum ghrelin response curve
timeFrame: For 4 hours after consuming the test meal
measure: Incremental area under the serum ghrelin response curve
timeFrame: For 2 hours after consuming the standard lunch
Locations:
Study officials:
affiliation: University of Toronto
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rahat-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.