NCT02562014

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

September 25, 2015

Last Update Submit

September 28, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Incremental area under the serum acetate response curve

    For 6 hours after consuming the test meal

Secondary Outcomes (12)

  • Incremental area under the serum propionate response curve

    For 6 hours after consuming the test meal

  • Incremental area under the serum butyrate response curve

    For 6 hours after consuming the test meal

  • Incremental area under the breath hydrogen response curve

    For 6 hours after consuming the test meal

  • Incremental area under the breath methane response curve

    For 6 hours after consuming the test meal

  • Incremental area under the serum glucose response curve

    For 4 hours after consuming the test meal

  • +7 more secondary outcomes

Other Outcomes (6)

  • Incremental area under the serum glucagon-like peptide-1 response curve

    For 4 hours after consuming the test meal

  • Incremental area under the serum glucagon-like peptide-1 response curve

    For 2 hours after consuming the standard lunch

  • Incremental area under the serum peptide-YY response curve

    For 4 hours after consuming the test meal

  • +3 more other outcomes

Study Arms (2)

Lean

OTHER

Participants with body mass index \<=25

Other: GlucoseOther: InulinOther: Resistant Starch

Overweight

OTHER

Participants with body mass index \>25

Other: GlucoseOther: InulinOther: Resistant Starch

Interventions

GlucoseOTHER

75g glucose

LeanOverweight
InulinOTHER

75g glucose plus 24g inulin

LeanOverweight
Resistant StarchOTHER

75g glucose plus 28.2g resistant starch

LeanOverweight

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 27966574DERIVED

  • 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.

    PMID: 27966565DERIVED

MeSH Terms

Conditions

Obesity

Interventions

GlucoseInulinResistant Starch

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesStarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesFructansPolysaccharidesDietary FiberFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Thomas MS Wolever, MD, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2015

First Posted

September 29, 2015

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

January 1, 2013

Last Updated

September 29, 2015

Record last verified: 2015-09