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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120661
• Other study ID #: NL78737.091.21
• Status: Completed
• Phase: N/A
• Start date: December 9, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: March 2024
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestion
• Metabolic Syndrome
• Microbiota
• Obesity
• Overweight

Intervention

Other:
• food product
a food product containing 50 gram carbohydrates

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial glucose response (iAUC) per test product	iAUC glucose	0-120 minutes
Primary	small intestine microbiome	the relative composition (%) and the functional capacity (%) of the small intestine microbiota	at baseline
Secondary	macronutrients in the small intestinal aspirates	amounts of carbohydrates, proteins, fats	0-240 minutes
Secondary	presence and production of (bacterial) degradation products in the small intestinal aspirates	concentrations of organic acids and short-chain fatty acids	0-240 minutes
Secondary	digestive enzymes in the small intestinal aspirates	concentrations of amylase	0-240 minutes
Secondary	non-absorbable marker in the small intestinal aspirates	peg-4000 concentrations	0-240 minutes
Secondary	blood HbA1c	concentrations of HbA1c	0-240 minutes
Secondary	blood glucose	concentrations glucose (e.g. GLP-1, PYY)	0-240 minutes
Secondary	blood insulin	concentrations of insulin	0-240 minutes
Secondary	blood glucagon	concentrations of glucagon	0-240 minutes
Secondary	blood total triglycerides	concentrations of triglycerides	0-240 minutes
Secondary	blood total free fatty acids	concentrations of free fatty acids	0-240 minutes
Secondary	plasma gut hormones	concentrations of gut hormones (e.g. GLP-1, PYY)	0-240 minutes
Secondary	breath 13C-lactosyl ureide	concentrations of 13C-lactosyl ureide	0-240 minutes
Secondary	breath hydrogen	concentrations of hydrogen (ppm)	0-240 minutes
Secondary	breath methane	concentrations of methane (ppm)	0-240 minutes
Secondary	Oral microbiome composition	microbiota relative composition (%)	baseline
Secondary	Salivary a-amylase	concentrations of a-amylase	0-240 minutes
Secondary	Fecal microbiota composition	microbiota relative composition (%)	baseline