Assessment and comparison of inflammatory responses upon challenges with glucose, fat, and a combination of glucose and fat
- Conditions
- inflammatory responses, algemene gezondheidfunctioning immune systeminflammatory responses
- Registration Number
- NL-OMON35991
- Lead Sponsor
- TNO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
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.
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 (<1 month prior to the start of the study)
12. For women: pregnant or lactating or wishing to become pregnant in the period of the study
13. Personnel of TNO (location Zeist), their partner and their first and second degree relatives
14. Not having a general practitioner
15. Not willing to accept notification concerning participation in the study to the subject*s general practitioner
16. Not willing to accept information transfer regarding health aspects, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from the subject*s general practitioner
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Blood samples will be collected at regular time points during a period of 10 h,<br /><br>and will be analyzed for inflammatory markers (cytokines/chemokines/acute phase<br /><br>markers), LPS, oxylipid profile, gene expression, haematology, and serum<br /><br>clinical chemical profile.<br /><br>Archive samples will be stored for possible later analyses within the scope of<br /><br>the study.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Body composition (bioimpedance measurement using the InBody); once every<br /><br>testday</p><br>