Challenge test, phenotypic flexibility, resilience, health, metabolic syndrome
Conditions
Interventions
An optimal diet based on dietary guidelines related to personal habits and
preferences and based on individual measurements (data from FFQ) for nine
weeks. The study objectives assessment required tha
Sponsors
PhenFlex2 consortium
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible to the study, male and female volunteers will have to fulfill the following criteria (assessment based on the medical examination performed at V0): 1. Males and females aged =45 years old; 2. Apparently healthy as assessed by the Health and Lifestyle questionnaire; 3. Body mass index 25-35 kg.m-2 (lower limit excluded and upper limit included); 4. Non restrained eater, based on the Three Factor Eating behavior Questionnaire (TFEQ), the eating factor 1 should be =131,2; 5. Presenting at least 2 aspects of metabolic syndrome according to NCEP ATP III (revision 2005) criteria: - Waist circumference = 88 centimeters for women and = 102 centimeters for men (this one is not applicable now when subjects have a BMI between 25-35 kg/m2); - Blood triglyceride level = 1.7 mmol/L, - HDL cholesterol level = 1.04 mmol/L for men and = 1.3 mmol/L for women, - Blood pressure = 130/85 millimeters mm Hg, - Fasting blood sugar = 5.6 mmol/L. 6. Able to drink the Phenflex drink (± 25% of the complete volume) and indicating that he/she will be able to consume a whole drink during the visits; 7. Able to use online technology on tablet and a PC/laptop which has good access to the internet; 8. Good general and mental health according to the medical investigator: no clinically significant and relevant abnormalities of medical history or physical examination; 9. Able and willing to voluntary participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form; 10. Affiliated with a social security scheme; 11. Women of child-bearing age: with a negative blood pregnancy test and using a method of contraception, since at least 3 months before the start of the study and deemed effective by the investigator: -combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) -progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) -intrauterine device (IUD) -intrauterine hormone-releasing system (IUS) -bilateral tubal occlusion -Hysterectomy, -ESSURE system -vasectomized partner; 12. Agree to be registered on the volunteers in biomedical research file.
Exclusion criteria
Exclusion criteria: 1. Participation in any clinical trial up to 30 days before day 1 of this study; 2. Participation in the previous Phenflex clinical trial: IDRCB 2018- A00375-50; 3. Suffering from a metabolic disorder such as diabetes mellitus, Cushing syndrome, thyroid disease, familial hypercholesterolemia; 4. Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease), 5. Suffering from an uncontrolled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg), 6. Under cholesterol and/or lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) or stopped for less than three months; 7. Prohibited medication: antidiabetic, lipid lowering treatment and some antihypertensive treatment (ß-blocking agents ; thiazide diuretics) ; corticosteroids ; antipsychotics (eg. clozapine, olanzapine) ; antidepressives ; Protease inhibitors ; anti-epileptics, calcineurine inhibitors; including cyclosporine and tacrolimus; 8. Having a history of medical or surgical events that may significantly affect the study outcome, including more than five years of cardiovascular disease or hypertension or more than two types of medication for CVD or hypertension; 9. Being physically active for more than 5 hours/week; 10. Having a history of food allergies or intolerances for nutrients/nutritional components such as lactose, nuts, etc; 11. Having chronic diseases such as chronic obstructive pulmonary disease (COPD), diabetes mellitus and inflammatory diseases; 12. Using prescribed pain medication or taking painkillers on a regular basis (judged by the investigator); 13. Smoking (irregular smoking in the weekend could be allowed to 10 cigarettes/day maximum); 14. Being pregnant or lactating or have a wish to become pregnant in the coming months; 15. Inappropriate veins and poor blood circulation for blood collection according to the investigator ; 16. Alcohol consumption: more than 3 standard drinks of alcoholic beverage for men or 2 standard drinks daily for women; 17. Reported unexplained weight loss or gain > 5% of body weight in the 3 months prior to the pre-study screening; 18. Reported slimming or (medically) prescribed diet; 19. Reported vegan, macrobiotic, paleo, raw food, intermittent fasting, Atkins, regular consumption of healthy food (food enriched with vitamins, minerals, antioxidants), a diet conviction; vegetarians are not excluded; 20. Being regular users of dietary supplements (supplementation can have a negative effect on the intervention); 21. With a personal history of anorexia nervosa, bulimia or significant eating disorders according to medical history from the subject; 22. Not willing to stop blood donation during the study; 23. Donation of blood in the 3 months preceding the study; 24. Donation of blood during the study up to 1 month after the end of the study; 25. Personnel of Biofortis, their partner and their first and second degree relatives; 26. Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros; 27. Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; 28. Presenting a psychological or lin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite biomarker representing “metabolic age” measured at all timepoints during the PhenFlex drink test day (t=0, 30, 60, 120, 240 min) at visits V1, V2 and V3. Variables included in the composite biomarker: Cholesterol, HDL-cholesterol, NEFA, glucose, Insulin, triglycerides The combined data will be used in a health space model and will provide the composite marker ‘metabolic age’. The metabolic age outcomes before and after the interventions will be compared as well as to the control. The primary endpoint compares the calculated difference of metabolic age between the intervention group and control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints, will analyze parameters below at visits V1, V2 and V3: ? Comparison of the “metabolic age” to the single parameters of which the composite biomarker is composed of ? Metabolic stress markers measured at all timepoints during the PhenFlex drink test day (t=0, 30, 60, 120, 240 min) at visits V1, V2 and V3: - Inflammatory markers (TNF-alpha, IL10, IL6, IL8), - hsCRP (only at t0), - hbA1c (only at t0), - GGT, ALAT, ASAT, Comparisons between the personalized dietary advice group and the control group will be done on all markers. | — |
Contacts
Public ContactWilrike Pasman
TNO, Utrechtseweg 48, 3704 HE Zeist
Outcome results
None listed