Healthy living Nutritional, Metabolic, Endocrine Healthy living
Conditions
Interventions
Participants are allocated to one of 10 groups according to gender, age and body fat %. All participants undergo a high-calorie challenge test during which a challenge drink is administered. The high
Sponsors
TNO
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male / female subjects (ratio: 50-50), 20 to 70 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, hematology and blood chemistry and the health and lifestyle questionnaire. 2. Body fat percentage within limits of predefined recruitment categories 3. Able to participate and willing to give written informed consent and to comply with the study restrictions
Exclusion criteria
Exclusion criteria: 1. Participation in an investigational drug or device study within 3 months prior to screening and / or participation of more than 4 times in the previous year 2. Loss of blood outside the limits of Sanquin (500 mL) within 3 months prior to screening or not willing to refrain from blood- or plasma donation during the study 3. Average alcohol consumption > 21 units/week for women and > 28 units/week for men 4. Change of smoking habits within two months prior to screening 5. Not having a general practitioner or health insurance 6. Unacceptable concomitant medication use at baseline, e.g., drugs known or likely to interact with the challenge drink or study assessments 7. Use of dietary supplements less than one month prior to Day 1 8. Reported slimming or being on a medically prescribed diet 9. Reported unexplained weight loss or gain of > 2 kg in the last month before screening 10. Reported food allergy or sensitivity for one of the used ingredients 11. Females who are pregnant, planning to be pregnant during the study period, or lactating 12. Not willing to accept information transfer which concerns participation in the study or information regarding health (e.g. laboratory results, findings at health and lifestyle questionnaire, physical examination or eventual adverse events) to and from their general practitioner 13. Having hypertension defined as a systolic blood pressure (SBP) greater than 140 mmHg or diastolic blood pressure (DBP) greater than 90 mmHg (assessed three times at five minutes interval). In the case of isolated systolic hypertension in middle aged volunteers (phenotypic group 5 and 10), the principal investigator will judge whether this condition will cause a clinically significant interference with the study outcome 14. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results. In the case of uncertain or questionable results, tests performed during screening may be repeated once before determination of eligibility 15. Inappropriate veins for cannula insertion 16. Having a chronic disease related to inflammation (such as arthritis) 17. Having a history or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder 18. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease 19. Unwillingness or inability to comply with the study protocol for any other reason For the sub investigation (Raman spectroscopy): 20. Dark skin color according to the Fitzpatrick skin type scale (type 5 or 6) 21. Abnormalities of the skin at the desired measurement location (upper side of forearm)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Markers of glucose metabolism (including, but not restricted to glucose, glucagon, GLP-1, insulin), markers of lipid metabolism (including, but not limited to triglycerides and cholesterol), hormones and markers for oxidative stress (including, but not limited to adiponectin, gastric inhibitory polypeptide, C-peptide, glutathione ratio), immunology related parameters (including, but not restricted to, C reactive protein, serum amyloid A, soluble intercellular adhesion molecule, soluble vascular cell adhesion molecule), markers of clinical chemistry (including, but not limited to gamma-GT, ALAT, ASAT, ALP, albumin, creatinin), metabolites measured by metabolomics technology in plasma (including, but not restricted to, endogenous metabolites involved in energy metabolism, urea cycle, glucose metabolism, ketone bodies, lipid metabolism and amino acids) are measured using blood samples collected at baseline (overnight fasting), 0.5, 1, 2, 4, 6 and 8 hours after challenge test. Furthermore, the amount of hunger and satiety measured by the ‘’VASfood’’ questionnaire at baseline (overnight fasting), 0.5, 1, 2, 4, 6 and 8 hours after challenge test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose is measured using Raman spectroscopy at baseline, 1, 2 and 4 hours after challenge test. | — |
Countries
Netherlands
Outcome results
None listed