NCT02795559

Brief Summary

It has been suggested that obesity occurs because the colonic microbes in obese individuals, compared to those who are lean, produce more short chain fatty acids during the fermentation of dietary fiber; this means that obese individuals obtain more energy from dietary fiber than lean. On the other hand, it is possible that the ability of colonic short chain fatty acids to improve glycemic control and suppress appetite may be reduced in obese subjects. The aim of this study was to determine the acute effects of 2 fibers commonly used as food ingredients, inulin and resistant starch, on postprandial serum responses of short chain fatty acids, glucose, insulin, free-fatty acids and selected gut hormones in lean and overweight or obese subjects.

Trial Health

87
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 Mar 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

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

March 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

4 months

First QC Date

June 6, 2016

Last Update Submit

June 9, 2016

Conditions

ObesityDiabetes

Keywords

NutritionHumansObesityBlood glucoseDietary fiberAppetiteShort chain fatty acids

Outcome Measures

Primary Outcomes (1)

  • Serum acetate response

    Incremental area under the curve of the serum acetate response from the lowest concentration achieved during the first 3 hours to the end of the study (6hr)

    0 to 6 hours after the intervention

Secondary Outcomes (27)

  • Serum propionate response

    0 to 6 hours after the intervention

  • Serum butyrate response

    0 to 6 hours after the intervention

  • Breath hydrogen response

    0 to 6 hours after the intervention

  • Energy intake

    3 days

  • Fat intake

    3 days

  • +22 more secondary outcomes

Study Arms (2)

Lean

OTHER

Subjects within the range of desirable body weight (BMI\<25)

Other: GlucoseOther: InulinOther: Resistant starch

OWO

OTHER

Subjects who are overweight or obese (BMI between 25 and 40)

Other: GlucoseOther: InulinOther: Resistant starch

Interventions

GlucoseOTHER

75g glucose dissolved in 300ml water

LeanOWO
InulinOTHER

75g glucose plus 24g inulin dissolved in 300ml water

LeanOWO
Resistant starchOTHER

75g glucose plus 28g resistant starch in 300ml water

LeanOWO

Eligibility Criteria

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

You may qualify if:

  • over 18 years of age

You may not qualify if:

  • Pregnant
  • BMI\<18 or \>39.9
  • diabetes
  • anaemia
  • use of diuretics of beta-blockers
  • regular user of antibiotics (≥1 course per year over the last 5 years)
  • any use of antibiotics within 3 months
  • use of laxatives, weight reducing agents, pre/probiotics or supplements known to influence gastrointestinal function within 3 months
  • presence of inflammatory bowel disease, malabsorption, motility disorder, gastrointestinal infection, short bowel, or other condition affecting gastrointestinal function
  • liver or kidney disease or major medical or surgical event (within the last 6 months) requiring hospitalization
  • high fibre intake (\>30g/day) or other abnormal dietary pattern
  • on a weight-loss diet or not on their habitual diet in the two months prior to the study
  • unwilling or unable to give informed consent and/or comply with study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glycemic Index Laboratories

Toronto, Ontario, M5C 2X3, Canada

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Interventions

GlucoseInulinResistant Starch

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

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

June 6, 2016

First Posted

June 10, 2016

Study Start

March 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 13, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)