NL-OMON35991CompletedNot Applicable
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
TNO0 sites14 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
Investigators
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