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The GLYSIMI study: Elucidating the role of human Small Intestine Microbiota in Interpersonal differences in GLYcemic responses upon consumption of food products. A proof of principle study.

The GLYSIMI study: Elucidating the role of human Small Intestine Microbiota in Interpersonal differences in GLYcemic responses upon consumption of food products. A proof of principle study. - GLYSIMI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50686
Enrollment
20
Registered
2021-11-15
Start date
2021-12-09
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

de darm: samenstelling en activiteit microbiota microbial activity

Interventions

Consumption of 2 standardized (combination of) food product(s), together with a non-absorbable marker (PEG-4000).

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Males and females - BMI equal or larger than 25 kg/m2 - Age 40-75 years - Signed informed consent

Exclusion criteria

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 dementia (e.g. Alzheimer's Disease, vascular dementia, Lewy body dementia) - 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; -Following a vegan diet; -Excessive alcohol consumption (on average >21 glasses/week for men and >14 glasses/week for women); -The use of recreational drugs; -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

Design outcomes

Primary

MeasureTime frame
The impact of the (combination of) food product(s) on postprandial glycemic responses and small intestine microbiota, and whether there is a relation between differences in small intestine microbiota and glycemic responses.

Secondary

MeasureTime frame
The expression of genes involved in glucose uptake and metabolism in cultured small intestine epithelial cells after exposure to luminal samples.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)