Glucose Tolerance
Conditions
Interventions
Acute intake of encapsulated quercetin in chitosan-coated microspheres and placebo capsuleNon-encapsulated quercetin in capsule combined with empty chitosan coated microspheres, 
empty chitosan coated microspheres and placebo capsule as control.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age between 18-65 years of age. BMI range (18.5–25 kg/m²)Normal fasting glucose (e.g. <5.6 mmol/L)
Exclusion criteria
Exclusion criteria: Allergy to quercetinSeafood allergyPeople with a vegan diet can not participate due to source of chitosanUse of supplements containing vitamins, minerals, or antioxidants four weeks prior to testing day.Use of antibiotics within 3 months prior to V1Having donated blood within one month before the start of the study, or planning to donate blood during the studyRegular smoking on a weekly or biweekly basis (including use of e-cigarettes)Drug use, interfering with any of the outcome parameters of this study; to be decided by the person who is medically responsible for this studyAbuse of alcohol (alcohol consumption >20 units/week) and/or drugsIntention to take part in any weight loss programConcurrent systemic disease and/or laboratory abnormalities considered by investigators to be detrimental for the participants safety or potentially interfering with the study procedures and/or study outcomeAbdominal surgery interfering with gastrointestinal function, upon judgement of the medical doctor, who will decide in-or exclusion based on the surgery appliedTreatment with an investigational drug (phase 1-3) 180 days before the start of the studyMedication intake that might interfere with endpoints or compromise participant safety during testing (e.g. glucose-lowering medications, angiotensin-converting enzyme (ACE) inhibitors, and statins) to be decided by the principal investigatorInability to understand study information and/or communicate with staffParticipants who have lactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to investigate the effects of acute dose of microencapsulated quercetin in chitosan coated sodium alginate microspheres on postprandial glucose levels in healthy adults. It is hypothesized that microencapsulation will enhance the reduction in postprandial glucose levels compared to non-encapsulated quercetin and the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The first secondary objective is to examine the effects of quercetin encapsulated in mucoadhesive microsphere on quercetin bioavailability by measuring quercetin absorption into the blood via HPLC analysis, by comparing pharmacokinetic parameters of encapsulated versus non-encapsulated quercetin, including maximum plasma concentration, time to reach maximum concentration and area under the curve (AUC). The second secondary objective is to quantify urinary excretion of quercetin metabolites as an indicator of apparent absorption, systemic appearance, and clearance. This will help determine the total absorbed dose and extent of metabolism. The third secondary objective is to assess the impact of encapsulated versus non-encapsulated quercetin on insulin response by calculating the insulinogenic index or HOMA-IR. Finally, gastrointestinal tolerance of the encapsulated microspheres will be investigated through self-reported questionnaires. | — |
Countries
Netherlands
Contacts
Public ContactCGM Dohmen
Universiteit Maastricht
Outcome results
None listed