Acute Effects of Dietary Fiber on Postprandial Responses in Lean and Overweight Subjects
Primary Purpose
Obesity, Diabetes
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Glucose
Inulin
Resistant starch
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring Nutrition, Humans, Obesity, Blood glucose, Dietary fiber, Appetite, Short chain fatty acids
Eligibility Criteria
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
Sites / Locations
- Glycemic Index Laboratories
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lean
OWO
Arm Description
Subjects within the range of desirable body weight (BMI<25)
Subjects who are overweight or obese (BMI between 25 and 40)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Serum propionate response
Incremental area under the curve of the serum propionate response from the lowest concentration achieved during the first 3 hours to the end of the study (6hr)
Serum butyrate response
Incremental area under the curve of the serum butyrate response from the lowest concentration achieved during the first 3 hours to the end of the study (6hr)
Breath hydrogen response
Incremental area under the curve of the breath hydrogen response from the lowest concentration achieved during the first 3 hours to the end of the study (6hr)
Energy intake
From 3-day diet record, mean energy intake.
Fat intake
From 3-day diet record, mean total fat intake.
Protein intake
From 3-day diet record, mean protein intake.
Carbohydrate intake
From 3-day diet record, mean available carbohydrate intake.
Dietary fiber intake
From 3-day diet record, mean dietary fiber intake.
Fecal microbiota
Ion Torrent V6 16S-rRNA sequencing for comparison of phyla
0-2 hour Glucose response
Incremental area under the curve of the serum glucose response from fasting to 2 hours.
2-4 hour Glucose response
Incremental area under the curve of the serum glucose response from 2 to 4 hours.
Second-meal glucose response
Total area under the curve of the serum glucose response for 2 hours after lunch.
0-2 hour Insulin response
Incremental area under the curve of the serum insulin response from fasting to 2 hours
2-4 hour Insulin response
Incremental area under the curve of the serum insulin response from 2 to 4 hours.
Second-meal Insulin response
Total area under the curve of the serum insulin response for 2 hours after lunch.
0-2 hour c-peptide response
Incremental area under the curve of the serum c-peptide response from fasting to 2 hours.
2-4 hour c-peptide response
Incremental area under the curve of the serum c-peptide response from 2 to 4 hours.
Second-meal c-peptide response
Total area under the curve of the serum c-peptide response for 2 hours after lunch.
Free-fatty acid rebound
Increase in serum free-fatty acid concentration from the lowest to the subsequent highest concentration before consuming lunch
Acute total glucagon-like peptide-1 response
Incremental area under the curve of the serum total glucagon-like peptide-1 response from 0 to 4 hours.
Post-lunch total glucagon-like peptide-1 response
Incremental area under the curve of the serum total glucagon-like peptide-1 response from 0 to 2 hours after lunch.
Acute active glucagon-like peptide-1 response
Incremental area under the curve of the serum active glucagon-like peptide-1 response from 0 to 4 hours.
Post-lunch active glucagon-like peptide-1 response
Incremental area under the curve of the serum active glucagon-like peptide-1 response from 0 to 2 hours after lunch.
Acute peptide tyrosine tyrosine response
Incremental area under the curve of the serum PYY response from 0 to 4 hours.
Post-lunch peptide tyrosine tyrosine response
Incremental area under the curve of the serum PYY response from 0 to 2 hours after lunch.
Acute ghrelin response
Incremental area under the curve of the serum ghrelin response from 0 to 4 hours.
Post-lunch ghrelin response
Incremental area under the curve of the serum ghrelin response from 0 to 2 hours after lunch.
Full Information
NCT ID
NCT02795559
First Posted
June 6, 2016
Last Updated
June 9, 2016
Sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT02795559
Brief Title
Acute Effects of Dietary Fiber on Postprandial Responses in Lean and Overweight Subjects
Official Title
Role of Colonic Short Chain Fatty Acids in Obesity: Acute Effects of Inulin and Resistant Starch on Postprandial Short Chain Fatty Acid, Glucose, Insulin, Free-fatty Acid and Gut Hormone Responses
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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:
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
determine the types of bacteria in the stools of lean and overweight subjects
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes
Keywords
Nutrition, Humans, Obesity, Blood glucose, Dietary fiber, Appetite, Short chain fatty acids
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lean
Arm Type
Other
Arm Description
Subjects within the range of desirable body weight (BMI<25)
Arm Title
OWO
Arm Type
Other
Arm Description
Subjects who are overweight or obese (BMI between 25 and 40)
Intervention Type
Other
Intervention Name(s)
Glucose
Intervention Description
75g glucose dissolved in 300ml water
Intervention Type
Other
Intervention Name(s)
Inulin
Intervention Description
75g glucose plus 24g inulin dissolved in 300ml water
Intervention Type
Other
Intervention Name(s)
Resistant starch
Intervention Description
75g glucose plus 28g resistant starch in 300ml water
Primary Outcome Measure Information:
Title
Serum acetate response
Description
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)
Time Frame
0 to 6 hours after the intervention
Secondary Outcome Measure Information:
Title
Serum propionate response
Description
Incremental area under the curve of the serum propionate response from the lowest concentration achieved during the first 3 hours to the end of the study (6hr)
Time Frame
0 to 6 hours after the intervention
Title
Serum butyrate response
Description
Incremental area under the curve of the serum butyrate response from the lowest concentration achieved during the first 3 hours to the end of the study (6hr)
Time Frame
0 to 6 hours after the intervention
Title
Breath hydrogen response
Description
Incremental area under the curve of the breath hydrogen response from the lowest concentration achieved during the first 3 hours to the end of the study (6hr)
Time Frame
0 to 6 hours after the intervention
Title
Energy intake
Description
From 3-day diet record, mean energy intake.
Time Frame
3 days
Title
Fat intake
Description
From 3-day diet record, mean total fat intake.
Time Frame
3 days
Title
Protein intake
Description
From 3-day diet record, mean protein intake.
Time Frame
3 days
Title
Carbohydrate intake
Description
From 3-day diet record, mean available carbohydrate intake.
Time Frame
3 days
Title
Dietary fiber intake
Description
From 3-day diet record, mean dietary fiber intake.
Time Frame
3 days
Title
Fecal microbiota
Description
Ion Torrent V6 16S-rRNA sequencing for comparison of phyla
Time Frame
1 day
Title
0-2 hour Glucose response
Description
Incremental area under the curve of the serum glucose response from fasting to 2 hours.
Time Frame
0 to 2 hours after consuming treatment
Title
2-4 hour Glucose response
Description
Incremental area under the curve of the serum glucose response from 2 to 4 hours.
Time Frame
2 to 4 hours after consuming treatment
Title
Second-meal glucose response
Description
Total area under the curve of the serum glucose response for 2 hours after lunch.
Time Frame
0 to 2 hours after lunch
Title
0-2 hour Insulin response
Description
Incremental area under the curve of the serum insulin response from fasting to 2 hours
Time Frame
0 to 2 hours after consuming treatment
Title
2-4 hour Insulin response
Description
Incremental area under the curve of the serum insulin response from 2 to 4 hours.
Time Frame
2-4 hours after consuming treatment
Title
Second-meal Insulin response
Description
Total area under the curve of the serum insulin response for 2 hours after lunch.
Time Frame
0-to 2 hours after lunch
Title
0-2 hour c-peptide response
Description
Incremental area under the curve of the serum c-peptide response from fasting to 2 hours.
Time Frame
0 to 2 hours after consuming treatment
Title
2-4 hour c-peptide response
Description
Incremental area under the curve of the serum c-peptide response from 2 to 4 hours.
Time Frame
2 to 4 hours after consuming treatment
Title
Second-meal c-peptide response
Description
Total area under the curve of the serum c-peptide response for 2 hours after lunch.
Time Frame
0-2 hours after lunch
Title
Free-fatty acid rebound
Description
Increase in serum free-fatty acid concentration from the lowest to the subsequent highest concentration before consuming lunch
Time Frame
0 to 4 hours after consuming intervention
Title
Acute total glucagon-like peptide-1 response
Description
Incremental area under the curve of the serum total glucagon-like peptide-1 response from 0 to 4 hours.
Time Frame
0 to 4 hours after consuming intervention
Title
Post-lunch total glucagon-like peptide-1 response
Description
Incremental area under the curve of the serum total glucagon-like peptide-1 response from 0 to 2 hours after lunch.
Time Frame
0 to 2 hours after consuming lunch
Title
Acute active glucagon-like peptide-1 response
Description
Incremental area under the curve of the serum active glucagon-like peptide-1 response from 0 to 4 hours.
Time Frame
0 to 4 hours after consuming intervention
Title
Post-lunch active glucagon-like peptide-1 response
Description
Incremental area under the curve of the serum active glucagon-like peptide-1 response from 0 to 2 hours after lunch.
Time Frame
0 to 2 hours after consuming lunch
Title
Acute peptide tyrosine tyrosine response
Description
Incremental area under the curve of the serum PYY response from 0 to 4 hours.
Time Frame
0 to 4 hours after consuming intervention
Title
Post-lunch peptide tyrosine tyrosine response
Description
Incremental area under the curve of the serum PYY response from 0 to 2 hours after lunch.
Time Frame
0 to 2 hours after consuming lunch
Title
Acute ghrelin response
Description
Incremental area under the curve of the serum ghrelin response from 0 to 4 hours.
Time Frame
0 to 4 hours after consuming intervention
Title
Post-lunch ghrelin response
Description
Incremental area under the curve of the serum ghrelin response from 0 to 2 hours after lunch.
Time Frame
0 to 2 hours after consuming lunch
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas MS Wolever, MD, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glycemic Index Laboratories
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2X3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Acute Effects of Dietary Fiber on Postprandial Responses in Lean and Overweight Subjects
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