Acute Effects of Dietary Fiber on Postprandial Responses in Lean and Overweight Subjects

NCT ID: NCT02795559

Last Updated: 2016-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The human colon (large intestine) contains hundreds of species of bacteria which exist in a symbiotic (mutually beneficial) relationship with their human host. The number and type of colonic bacteria varies in different people. Recent studies show that overweight individuals have different types of bacteria in their colons than lean subjects, and that as overweight subjects lose weight their colonic bacteria change to resemble those in lean subjects. It was suggested that this was because the bacteria in overweight people more efficiently ferment dietary fiber thus producing more SCFAs and providing more energy to the body. However, this is not consistent with other studies showing that high fiber intakes are associated with reduced risk of obesity.

Some studies have shown that overweight people have higher concentrations of SCFA in their stool samples. But the reasons for the difference in stool concentrations of SCFA have not been studied. Stool concentrations of SCFA may differ in lean and overweight people because of differences in type of bacteria in their colons, differences in dietary intakes or maybe because lean and overweight people absorb SCFA produced by bacteria differently.

Therefore, the objectives of this study were to:

1. determine the relationship between SCFA production and the acute effects of consuming an unabsorbed carbohydrate on blood SCFA, FFA, glucose, insulin, c-peptide and gut hormone responses in lean and overweight subjects
2. determine the types of bacteria in the stools of lean and overweight subjects
3. to see if the types of bacteria are correlated with body weight, the composition of the diet, breath gases, fecal SCFA and other demographic and lifestyle factors.

Healthy subjects with a BMI \<25 (lean) or between 25 and 35 (overweight or obese; OWO) took part in a 2 phase study. In phase 1 subjects recorded their dietary intake for 3 days and then provided a stool sample for analysis of micro-organisms and short chain fatty acids. In phase 2 overnight fasted subjects were studied on 3 occasions separated by about a week. On each occasion subjects consumed a control test meal of dextrose, or dextrose plus inulin or dextrose plus resistant start and had breath and blood samples taken at intervals over 4 hours. Subjects were then given a standardized lunch and had more blood and breath samples taken over the next 2 hours.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lean

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

Group Type OTHER

Glucose

Intervention Type OTHER

75g glucose dissolved in 300ml water

Inulin

Intervention Type OTHER

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

Resistant starch

Intervention Type OTHER

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

OWO

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

Group Type OTHER

Glucose

Intervention Type OTHER

75g glucose dissolved in 300ml water

Inulin

Intervention Type OTHER

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

Resistant starch

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glucose

75g glucose dissolved in 300ml water

Intervention Type OTHER

Inulin

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

Intervention Type OTHER

Resistant starch

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* over 18 years of age

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thomas Wolever

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas MS Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Glycemic Index Laboratories

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Protocol Reference # 27112

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effects of Butyrate on Children With Obesity
NCT02721953 UNKNOWN PHASE2/PHASE3