Personalized healthy diet

Conditions: Challenge test, phenotypic flexibility, resilience, health, metabolic syndrome

Registration Number: NL-OMON23314

Lead Sponsor: PhenFlex2 consortium

Brief Summary: Stroeve, J. H. M., van Wietmarschen, H., Kremer, B. H. A., van Ommen, B. & Wopereis, S. Phenotypic flexibility as a measure of health: the optimal nutritional stress response test. Genes Nutr. 10, 13 (2015). - van Ommen, B. & Wopereis, S. Next-Generation Biomarkers of Health. e tl t . Inst. Workshop Ser. 84, 25–33 (2016).

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: Not specified

Target Recruitment: 110

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite biomarker representing metabolic age” measured at all<br>timepoints during the PhenFlex drink test day (t=0, 30, 60, 120, 240 min) at<br>visits V1, V2 and V3.<br><br>Variables included in the composite biomarker:<br>Cholesterol, HDL-cholesterol, NEFA, glucose, Insulin, triglycerides<br>The combined data will be used in a health space model and will provide the<br>composite marker ‘metabolic age’. The metabolic age outcomes before and<br>after the interventions will be compared as well as to the control.<br>The primary endpoint compares the calculated difference of metabolic age<br>between the intervention group and control group.<br>

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints, will analyze parameters below at visits V1, V2 and<br>V3:<br>? Comparison of the metabolic age” to the single parameters of which<br>the composite biomarker is composed of<br>? Metabolic stress markers measured at all timepoints during the<br>PhenFlex drink test day (t=0, 30, 60, 120, 240 min) at visits V1, V2 and<br>V3:<br>- Inflammatory markers (TNF-alpha, IL10, IL6, IL8),<br>- hsCRP (only at t0),<br>- hbA1c (only at t0),<br>- GGT, ALAT, ASAT,<br>Comparisons between the personalized dietary advice group and the control<br>group will be done on all markers.