compromised health, lifestyle related diseases
Conditions
Interventions
A healthy diet personalized to the subject based on individual measurements for nine weeks and a diet based on the general recommended French dietary guidelines.
Sponsors
TNO
Name – First name: Dijk-Stroeve, Annelies, PhD
Address: TNO
Utrechtseweg 48
3704HE Zeist
The Netherlands
Phone: +31 888 66 3637
Eligibility
Inclusion criteria
Inclusion criteria: Males and females aged between ≥25 and ≤70 years at day 1 of the study (limits included); 2. Apparently healthy as assessed by the Health and Lifestyle questionnaire; 3. Body mass index 20-35 kg.m-2 (limits included) (preferably BMI range 25-35 will be included first when possible); 4. Non restrained eater, based on the Three Factor Eating behavior Questionnaire (TFEQ)(15) 5. Able to use online technology on smartphone and a PC/laptop which has good access to the internet; 6. Appropriate veins and circulation for blood sampling according to Biofortis; 7. Good general and mental health according to the investigator: no clinically significant and relevant abnormalities of medical history or physical examination; 8. 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; 9. Affiliated with a social security scheme; 10. 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; 11. Agree to be registered on the volunteers in biomedical research file.
Exclusion criteria
Exclusion criteria: 1. Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 of this study; 2. Participation in any non-invasive clinical trial up to 30 days before day 1 of this study, including no blood sampling and/or oral, intravenous, or inhalatory administration of substances; 3. 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; 4. Having a history of food allergies or intolerances for nutrients/nutritional components such as lactose, nuts, etc; 5. Having a gastrointestinal disease such as celiac disease, Chron¡¯s disease, inflammatory bowel disease; 6. Having chronic diseases such as metabolic syndrome, chronic obstructive pulmonary disease (COPD), diabetes mellitus and inflammatory diseases 7. Using prescribed medication or taking painkillers on a regular basis (judged by the medical investigator); medication for CVD is allowed when not more than 2 types of medication are used; 8. Smoking (irregular smoking in the weekend is allowed) *; 9. Being pregnant or lactating; 10. Alcohol consumption: more than 3 standard drinks of alcoholic beverage for men or 2 standard drinks daily for women; 11. Reported unexplained weight loss or gain > 5% of body weight in the 3 months prior to the pre-study screening; 12. Reported slimming or (medically) prescribed diet; 13. Reported vegan, macrobiotic, paleo, raw food, intermittent fasting, Atkins, regular consumption of superfoods, a diet conviction; vegetarians are not excluded; 14. Being regular users of dietary supplements (supplementation can have a negative effect on the intervention); 15. With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator; 16. Not willing to give up blood donation during the study; 17. Donation of blood in the 3 months preceding the study 18. Donation of blood during the study up to 3 months after the end of the study 19. Personnel of Biofortis, their partner and their first and second degree relatives; 20. Taking part in another clinical trial or being in the exclusion period of a previous clinical trial; 21. Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros; 22. Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; 23. Presenting a psychological or linguistic incapability to sign the informed consent; 24. Impossible to contact in case of emergency.
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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Metabolic stress markers measured at all timepoints during the PhenFlex drink test day (t=0, 30, 60, 120, 240 min) The additional effect of personalizing the advice compared to general advice and control, on all markers. | — |
Contacts
Public ContactWilrike Pasman
TNO
Outcome results
None listed