Elucidating the Role of Human Small Intestine Microbiota in Explaining Differences in Postprandial Glucose Responses
Condition: Metabolic Syndrome; Obesity; Overweight; Microbiota; Small Intestine; Digestion
MeSH terms: Overweight; Metabolic Syndrome
Study type: Interventional

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.
    

Intervention name(s): food product
Intervention type(s): Other
Intervention description(s): a food product containing 50 gram carbohydrates
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science