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Assessment and comparison of inflammatory responses upon challenges with glucose, fat, and a combination of glucose and fat

Assessment and comparison of inflammatory responses upon challenges with glucose, fat, and a combination of glucose and fat - Inflammatory responses upon challenges with glucose and/or fat

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35991
Enrollment
14
Registered
2011-04-20
Start date
2011-06-09
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

inflammatory responses, algemene gezondheid functioning immune system inflammatory responses

Interventions

4 = 75 g glucose + 200 ml whipping cream (Oral glucose + lipid tolerance test). The study substances need to be consumed within 10 minutes.
Four study substances will be administered once to all participants: 1 = Control (water)
2 = 75 g glucose drink (Oral glucose tolerance test)
3 = 200 ml whipping cream (Oral lipid tolerance test)

Sponsors

TNO
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Healthy as assessed by: a. The TNO health and lifestyle questionnaire (P9248 F02) b. Results of the pre-study laboratory tests in blood c. Assessment of physical characteristics 2. Age 30-60 y at Day 01 of the study 3. Body Mass Index (BMI) of 20 - 25 kg/m2 4. Voluntary participation 5. Having given written informed consent 6. Willing to comply with the study procedures 7. Willing to give up blood donation during the study 8. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years 9. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

Exclusion criteria

Exclusion criteria: 1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study 2. Having a history of medical or surgical events that may significantly affect the study outcome (as judged by the medical investigator) 3. Having a chronic disease related to inflammation or allergy (e.g. rheumatoid arthritis, inflammatory bowel disease, asthma, eczema) 4. Chronic use of medication that may affect inflammatory processes (e.g. NSAIDs, aspirin, antibiotics) 5. Regular use of lipid lowering medication and/or cholesterol lowering products (e.g. Becel Pro-activ) 6. Lactose intolerance or other food allergies 7. Reported slimming or medically prescribed diet 8. Smoking 9. Alcohol consumption > 28 units/week for males and > 21 units/week for females 10.Extreme physical exercise 11. Recent blood donation (

Design outcomes

Primary

MeasureTime frame
Blood samples will be collected at regular time points during a period of 10 h, and will be analyzed for inflammatory markers (cytokines/chemokines/acute phase markers), LPS, oxylipid profile, gene expression, haematology, and serum clinical chemical profile. Archive samples will be stored for possible later analyses within the scope of the study.

Secondary

MeasureTime frame
Body composition (bioimpedance measurement using the InBody); once every testday

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)