The Effect of the Consumption of 4 Botanical Extracts on... | NCT05117385

Name	Class
Biofortis Mérieux NutriSciences	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acerola	Experimental	dietary supplement : acerola extract self administrated by mouth for 28 days 1 capsule per day	Dietary Supplement: Botanical extract
Panax ginseng extract	Experimental	dietary supplement : panax ginseng extract self administrated by mouth for 28 days 1 capsule per day	Dietary Supplement: Botanical extract
Echinacea extract	Experimental	dietary supplement : echinacea extract self administrated by mouth for 28 days 1 capsule per day	Dietary Supplement: Botanical extract
Quillaja extract	Experimental	dietary supplement : quillaja extract self administrated by mouth for 28 days 1 capsule per day	Dietary Supplement: Botanical extract
Maltodextrin	Placebo Comparator	dietary supplement : maltodextrin supplement self administrated by mouth for 28 days 1 capsule per day	Dietary Supplement: Botanical extract

Name	Type	Description	Arm Group Labels	Other Names
Botanical extract	Dietary Supplement	1 capsule per day	Acerola Echinacea extract Maltodextrin Panax ginseng extract Quillaja extract

Measure	Description	Time Frame
Ex vivo Immune blood cell response after challenges at baseline (before supplementation) and after 28 days of each botanical consumption compared to placebo	Innate immunity like response and adaptative cell activation	28 days

Measure	Description	Time Frame
1. Frequency of innate and adaptative immune cell before and after 28 days of consumption of each botanical extract compared to placebo	The variation between both visits of the frequency of several circulating cells from innate and adaptative immunity expressed in % of white blood cells and absolute values	28 days

Eligibility Module

Eligibility Criteria

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 physical activity patterns in the last 4 weeks
Consumption of citrus fruits and fruit juices limited to two servings per day maximum in 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 hormonal contraception, surgery (ligation, bilateral ovariectomy), copper intrauterine device) since at least 3 cycles before the beginning of the study and agreeing to keep it during 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: no clinically significant and relevant abnormalities of medical history or physical examination
Able and willing to participate to the study by complying with the protocol procedures as 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 following criteria:

Normal values of complete blood count (CBC), hemoglobin, hematocrit, MVC (mean corpuscular volume), MCH (mean corpuscular haemoglobin), HCT (haematocrit), MCHC mean corpuscular haemoglobin concentration), RDW (Red cells Distribution width), MPV (mean platelet volume), PCT (plateletcrit), ASAT (aspartate aminotransferase), ALAT (alanine aminotransferase), urea, creatinine, HDL-cholesterol, LDL-cholesterol, total cholesterol, TG (triglycerides), glycemia according to the investigators' opinion
Negative pregnancy test: blood beta HCG < 5 IU/L for women in childbearing age

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 for an 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 week of moderate activity (which ask for a moderate physical effort and need to breathe a little bit more than usual; for example lift moderate load, quiet biking… )
With a past or current allergic rhinitis (sneezing, eye and nose scratching) and/or asthma (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 treated hypo/hyperthyroidism for less than 3 months (treated hypo/hyperthyroidism stabilized for at least 3 months is accepted)
Untreated hypertension, or uncontrolled hypertension, or treated hypertension for less than 3 months (treated hypertension stabilized for at least 3 months is accepted)
Untreated hypercholesterolemia or uncontrolled hypercholesterolemia or treated hypercholesterolemia for less than 3 months according to the investigator's opinion (treated and controlled hypercholesterolemia stabilized for at least 3 months is accepted according to the investigator's opinion)
Past or current inflammatory disease with an impact on immune responses (rheumatoid arthritis, bone metabolic disease, psoriasis, gout, symptomatic chondrocalcinosis and active 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 hematological cancers (exception: basal cell carcinoma, or non-squamous cell skin cancer, prostate cancer, or in situ carcinoma without any significative progression in the past 2 years)
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 cold formulas, anti-inflammatory drugs (nonsteroidal anti-inflammatory drugs, ibuprofen, cyclo-oxygenase 2 inhibitors) and therapy with immunostimulants (cytokines, thymus fractions) 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…) in the last 4 weeks
Bariatric surgery or any disease that could lead to intestinal malabsorption of the study products
With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient
Pregnant and/or breastfeeding women or intending to become pregnant in the next 3 months
Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity
With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator
Currently participating to another clinical trial or volunteer who has ended his participation to a previous clinical study in the past 90 days
Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros
Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision
Presenting a psychological or linguistic incapability to sign the informed consent
Impossible to contact in case of emergency

Name	Role	Phone	Extension	Email
Géraldine Krausz, PhD	Contact	+33 7 76 32 52 24		geraldine.krausz@givaudan.com
Pascale Fança-Berthon, PhD	Contact	+33 7 89 04 30 24		pascale.fanca-berthon@givaudan.com