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

NCT05120661 | Completed

• 1 other identifier: NL78737.091.21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Obesity; Overweight; Microbiota; Small Intestine; Digestion

Outcome Measures

Primary Outcomes (2)

• postprandial glucose response (iAUC) per test product

  iAUC glucose

  0-120 minutes

• small intestine microbiome

  the relative composition (%) and the functional capacity (%) of the small intestine microbiota

  at baseline

Secondary Outcomes (17)

• macronutrients in the small intestinal aspirates

  0-240 minutes

• presence and production of (bacterial) degradation products in the small intestinal aspirates

  0-240 minutes

• digestive enzymes in the small intestinal aspirates

  0-240 minutes

• non-absorbable marker in the small intestinal aspirates

  0-240 minutes

• blood HbA1c

  0-240 minutes

Study Arms (2)

Carbohydrate-rich food product (to be determined)

EXPERIMENTAL

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

Other: food product

Another carbohydrate-rich food product (to be determined)

EXPERIMENTAL

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

Other: food product

Interventions

food product OTHER

a food product containing 50 gram carbohydrates

Another carbohydrate-rich food product (to be determined); Carbohydrate-rich food product (to be determined)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Wageningen University

Wageningen, Gelderland, Netherlands

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity; Overweight

Interventions

Food

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 15, 2021
• Study Start: December 9, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)