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Elucidating the Role of Human Small Intestine Microbiota in Explaining Differences in Postprandial Glucose Responses (GLYSIMI)

Primary Purpose

Metabolic Syndrome, Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
food product
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females
  • BMI≥25 kg/m2
  • Age 40-75 years
  • Signed informed consent

Exclusion Criteria:

  • Having a history of medical or surgical events that may either put the subject at risk because of participation in the study, or influence the results of the study, including diabetes type 1, a swallowing disorder, gastrointestinal or liver disease, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants;
  • Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia;
  • Use of antibiotics within 2 months of starting the study or planned during the study;
  • Use of medication that could influence the study results, such as diabetes treatment;
  • Use of pro- and prebiotic supplements;
  • Sensitive to medical skin adhesives;
  • Having an allergy or intolerance towards compounds in the test products;
  • Follows a vegan diet;
  • Excessive alcohol consumption (on average >21 glasses/week for men and >14 glasses/week for women);
  • Currently a research subject in another clinical trial;
  • Having blood vessels that are too difficult for inserting a cannula/blood drawing'
  • Having a hemoglobin level <8.5 mmol/l (men) or <7.5 mmol/l (women);
  • Being a blood donor during the duration of the study;
  • Not having a General Practitioner (GP);
  • Being an employee of Wageningen University, division Human Nutrition and Health.

Sites / Locations

  • Wageningen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Carbohydrate-rich food product (to be determined)

Another carbohydrate-rich food product (to be determined)

Arm Description

This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates.

This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates.

Outcomes

Primary Outcome Measures

postprandial glucose response (iAUC) per test product
iAUC glucose
small intestine microbiome
the relative composition (%) and the functional capacity (%) of the small intestine microbiota

Secondary Outcome Measures

macronutrients in the small intestinal aspirates
amounts of carbohydrates, proteins, fats
presence and production of (bacterial) degradation products in the small intestinal aspirates
concentrations of organic acids and short-chain fatty acids
digestive enzymes in the small intestinal aspirates
concentrations of amylase
non-absorbable marker in the small intestinal aspirates
peg-4000 concentrations
blood HbA1c
concentrations of HbA1c
blood glucose
concentrations glucose (e.g. GLP-1, PYY)
blood insulin
concentrations of insulin
blood glucagon
concentrations of glucagon
blood total triglycerides
concentrations of triglycerides
blood total free fatty acids
concentrations of free fatty acids
plasma gut hormones
concentrations of gut hormones (e.g. GLP-1, PYY)
breath 13C-lactosyl ureide
concentrations of 13C-lactosyl ureide
breath hydrogen
concentrations of hydrogen (ppm)
breath methane
concentrations of methane (ppm)
Oral microbiome composition
microbiota relative composition (%)
Salivary α-amylase
concentrations of a-amylase
Fecal microbiota composition
microbiota relative composition (%)

Full Information

First Posted
October 11, 2021
Last Updated
October 19, 2023
Sponsor
Wageningen University
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1. Study Identification

Unique Protocol Identification Number
NCT05120661
Brief Title
Elucidating the Role of Human Small Intestine Microbiota in Explaining Differences in Postprandial Glucose Responses
Acronym
GLYSIMI
Official Title
Elucidating the Role of Human Small Intestine Microbiota in Interpersonal Differences in GLYcemic Responses Upon Consumption of Food Products: A Proof of Principle Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wageningen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. The role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products will be investigated. First a screening will take place with to choose the test products that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. The study will be a 6-day randomized cross-over trial with two test days. Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test will be provided to participants. Twenty men or women (BMI≥25 kg/m2, 40-75 years old) will be included. The main study parameters/endpoints are the food product-induced plasma glucose responses (iAUC) and the small intestine microbiota.
Detailed Description
Rationale: It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. Differences in small intestine microbiota are hypothesized to be key in explaining the interpersonal differences in glycemic responses. Objective: To investigate the role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products. Study design: The subjects will wear a continuous glucose monitor during the screening and the study. First a screening (14 days in total) will take place with to choose the test products (2 out of 4) that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. Also an OGTT will be performed. The study will be a randomized cross-over trial with two test days (length of trial is 6 days in total). During the trial, the subjects will be intubated with a naso-jejunum catheter. Study population: Twenty men or women (BMI≥25 kg/m2, 40-75 years old). Intervention (if applicable): Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test. Main study parameters/endpoints: test (food) product-induced plasma glucose responses (iAUC), small intestine microbiota.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity, Overweight, Microbiota, Small Intestine, Digestion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbohydrate-rich food product (to be determined)
Arm Type
Experimental
Arm Description
This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates.
Arm Title
Another carbohydrate-rich food product (to be determined)
Arm Type
Experimental
Arm Description
This is a nutritional product, such as bread or cake, containing 50 gram carbohydrates.
Intervention Type
Other
Intervention Name(s)
food product
Intervention Description
a food product containing 50 gram carbohydrates
Primary Outcome Measure Information:
Title
postprandial glucose response (iAUC) per test product
Description
iAUC glucose
Time Frame
0-120 minutes
Title
small intestine microbiome
Description
the relative composition (%) and the functional capacity (%) of the small intestine microbiota
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
macronutrients in the small intestinal aspirates
Description
amounts of carbohydrates, proteins, fats
Time Frame
0-240 minutes
Title
presence and production of (bacterial) degradation products in the small intestinal aspirates
Description
concentrations of organic acids and short-chain fatty acids
Time Frame
0-240 minutes
Title
digestive enzymes in the small intestinal aspirates
Description
concentrations of amylase
Time Frame
0-240 minutes
Title
non-absorbable marker in the small intestinal aspirates
Description
peg-4000 concentrations
Time Frame
0-240 minutes
Title
blood HbA1c
Description
concentrations of HbA1c
Time Frame
0-240 minutes
Title
blood glucose
Description
concentrations glucose (e.g. GLP-1, PYY)
Time Frame
0-240 minutes
Title
blood insulin
Description
concentrations of insulin
Time Frame
0-240 minutes
Title
blood glucagon
Description
concentrations of glucagon
Time Frame
0-240 minutes
Title
blood total triglycerides
Description
concentrations of triglycerides
Time Frame
0-240 minutes
Title
blood total free fatty acids
Description
concentrations of free fatty acids
Time Frame
0-240 minutes
Title
plasma gut hormones
Description
concentrations of gut hormones (e.g. GLP-1, PYY)
Time Frame
0-240 minutes
Title
breath 13C-lactosyl ureide
Description
concentrations of 13C-lactosyl ureide
Time Frame
0-240 minutes
Title
breath hydrogen
Description
concentrations of hydrogen (ppm)
Time Frame
0-240 minutes
Title
breath methane
Description
concentrations of methane (ppm)
Time Frame
0-240 minutes
Title
Oral microbiome composition
Description
microbiota relative composition (%)
Time Frame
baseline
Title
Salivary α-amylase
Description
concentrations of a-amylase
Time Frame
0-240 minutes
Title
Fecal microbiota composition
Description
microbiota relative composition (%)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females BMI≥25 kg/m2 Age 40-75 years Signed informed consent Exclusion Criteria: Having a history of medical or surgical events that may either put the subject at risk because of participation in the study, or influence the results of the study, including diabetes type 1, a swallowing disorder, gastrointestinal or liver disease, renal failure, cancer, nose/throat diseases, gastric bypass surgery, use of anticoagulants; Having a bleeding/coagulation disorder, including hemophilia, Von Willebrand disease, Bernard-Soulier, Glanzmann thrombasthenia or thrombocytopenia; Use of antibiotics within 2 months of starting the study or planned during the study; Use of medication that could influence the study results, such as diabetes treatment; Use of pro- and prebiotic supplements; Sensitive to medical skin adhesives; Having an allergy or intolerance towards compounds in the test products; Follows a vegan diet; Excessive alcohol consumption (on average >21 glasses/week for men and >14 glasses/week for women); Currently a research subject in another clinical trial; Having blood vessels that are too difficult for inserting a cannula/blood drawing' Having a hemoglobin level <8.5 mmol/l (men) or <7.5 mmol/l (women); Being a blood donor during the duration of the study; Not having a General Practitioner (GP); Being an employee of Wageningen University, division Human Nutrition and Health.
Facility Information:
Facility Name
Wageningen University
City
Wageningen
State/Province
Gelderland
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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Elucidating the Role of Human Small Intestine Microbiota in Explaining Differences in Postprandial Glucose Responses

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