NL-OMON23314Other不适用
Phenflex-based resilience as a measure for health effect of personalized diet
PhenFlex2 consortium0 个研究点目标入组 110 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- 入组人数
- 110
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
- •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
- •- 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
- •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.
排除标准
- •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
- •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;
- 另有 8 项未显示
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