Last updated: November 23, 2021
Sponsor: Naturex SA
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT05117385
2021-A01973-38
Ages 40-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age between 40 and 60 years (limits included)
- 18,5 < Body Mass Index < 30 kg/m2
- Without modification of their normal eating/drinking habits, body weight and physicalactivity patterns in the last 4 weeks
- Consumption of citrus fruits and fruit juices limited to two servings per day maximumin the last 7 days
- Consumption of caffeine < 400 mg/day in the last 2 weeks
- For non-menopausal women: with the same reliable contraception (oral or local hormonalcontraception, surgery (ligation, bilateral ovariectomy), copper intrauterine device)since at least 3 cycles before the beginning of the study and agreeing to keep itduring the entire duration of the study
- For menopausal women: without hormone replacement therapy
- Daily consumption of alcohol less than 2 glasses
- Non-smoking or tobacco consumption stopped for at least 12 months
- Good general and mental health according to the opinion of the investigator: noclinically significant and relevant abnormalities of medical history or physicalexamination
- Able and willing to participate to the study by complying with the protocol proceduresas evidenced by his dated and signed informed consent form
- Affiliated with a social security scheme
- Accepts to be registered to the VRB site (Volunteers in Biomedical Research database) After V0 biological analysis the subjects will be eligible to the study on the followingcriteria:
- Normal values of complete blood count (CBC), hemoglobin, hematocrit, MVC (meancorpuscular volume), MCH (mean corpuscular haemoglobin), HCT (haematocrit), MCHC meancorpuscular haemoglobin concentration), RDW (Red cells Distribution width), MPV (meanplatelet volume), PCT (plateletcrit), ASAT (aspartate aminotransferase), ALAT (alanineaminotransferase), urea, creatinine, HDL-cholesterol, LDL-cholesterol, totalcholesterol, TG (triglycerides), glycemia according to the investigators' opinion
- Negative pregnancy test: blood beta HCG < 5 IU/L for women in childbearing age
Exclusion
Exclusion Criteria:
- Any vaccination 6 weeks before inclusion visit and/or any vaccination during the study
- Specific food diet/habits: high protein or vegan diet
- Subjects who exercise more than 150 min per weeks of intense activity (which ask foran important physical effort and need to breathe much more than usual; for example,lift heavy load, mountain biking, playing football..) and more than 5 hours per weekof moderate activity (which ask for a moderate physical effort and need to breathe alittle bit more than usual; for example lift moderate load, quiet biking… )
- With a past or current allergic rhinitis (sneezing, eye and nose scratching) and/orasthma (cough, wheezing, shortness of breath)
- With a current or past disorder of neuropathy / diabetic neuropathy
- Suffering from a metabolic or endocrine disorder
- SBP > 139 and/or DBP > 89 mmHg
- Treated or untreated diabetes and/or any pancreatic disease
- With a current or past cardiac disease
- With a current or past liver disease (cirrhosis, fibrosis, NASH…)
- With a current or past pulmonary disease
- With a current or past renal disease
- With a significant risk of bladder/kidney stones
- Infectious disease in the last 6 weeks
- Untreated hypo/hyperthyroidism, or uncontrolled hypo/hyperthyroidism or treatedhypo/hyperthyroidism for less than 3 months (treated hypo/hyperthyroidism stabilizedfor at least 3 months is accepted)
- Untreated hypertension, or uncontrolled hypertension, or treated hypertension for lessthan 3 months (treated hypertension stabilized for at least 3 months is accepted)
- Untreated hypercholesterolemia or uncontrolled hypercholesterolemia or treatedhypercholesterolemia for less than 3 months according to the investigator's opinion (treated and controlled hypercholesterolemia stabilized for at least 3 months isaccepted according to the investigator's opinion)
- Past or current inflammatory disease with an impact on immune responses (rheumatoidarthritis, bone metabolic disease, psoriasis, gout, symptomatic chondrocalcinosis andactive infection…)
- Immunodeficient volunteer and/or current immunosuppressive therapy
- With a current or past auto-immune disease or immunodeficiency
- Gastrointestinal disease, gastroenteritis (within 4 weeks), intestinal occlusion,prolonged severe diarrhea, severe regurgitation, difficulty for swallowing
- Current cancer or in remission < 5 years and/or any past or current hematologicalcancers (exception: basal cell carcinoma, or non-squamous cell skin cancer, prostatecancer, or in situ carcinoma without any significative progression in the past 2years)
- Antibiotics consumption in the past 3 months
- Chronic antiviral and/or antibacterial treatment
- Current heparin treatment or anti-coagulation drug
- Consumption of laxative in the past 3 months
- Subjects who take, nasal steroids, decongestants, antihistamines, combination coldformulas, anti-inflammatory drugs (nonsteroidal anti-inflammatory drugs, ibuprofen,cyclo-oxygenase 2 inhibitors) and therapy with immunostimulants (cytokines, thymusfractions) in the last 4 weeks
- Consumption of any food supplement (including but not limited to omega-3-fatty acid,probiotic supplements, vitamin, mineral supplement, herbal immunostimulant, etc…) inthe last 4 weeks
- Bariatric surgery or any disease that could lead to intestinal malabsorption of thestudy products
- With a known or suspected food allergy or intolerance or hypersensitivity to any ofthe study products' ingredient
- Pregnant and/or breastfeeding women or intending to become pregnant in the next 3months
- Having a lifestyle deemed incompatible with the study according to the investigatorincluding high level physical activity
- With a personal history of anorexia nervosa, bulimia or significant eating disordersaccording to the investigator
- Currently participating to another clinical trial or volunteer who has ended hisparticipation to a previous clinical study in the past 90 days
- Having received, during the last 12 months, indemnities for clinical trial higher orequal to 4500 Euros
- Under legal protection (guardianship, wardship) or deprived from his rights followingadministrative or judicial decision
- Presenting a psychological or linguistic incapability to sign the informed consent
- Impossible to contact in case of emergency
Study Design
Total Participants: 115
Study Start date:
November 22, 2021
Estimated Completion Date:
July 18, 2022
Study Description
Connect with a study center
Biofortis Merieux Nutrisciences
Saint-Herblain, 44800
FranceActive - Recruiting

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