The Effect of the Consumption of 4 Botanical Extracts on Immunity in Healthy Adults (B-4-Immune)

NCT05117385 | Unknown

• 1 other identifier: 2021-A01973-38
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the capacity of botanical extracts to modulate immune mechanisms compared to a placebo group in healthy volunteers.

Conditions

Healthy Subject; Immunity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 1. Frequency of innate and adaptative immune cell before and after 28 days of consumption of each botanical extract compared to placebo

  28 days

• 2. Variation of quality of life before and after 28 days of consumption of each botanical extract compared to placebo

  28 days

Study Arms (5)

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

Interventions

Botanical extract DIETARY_SUPPLEMENT

1 capsule per day

Acerola; Echinacea extract; Maltodextrin; Panax ginseng extract; Quillaja extract

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 40 and 60 years (limits included)
• ,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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Givaudan France Naturals: lead
• Biofortis Mérieux NutriSciences: collaborator

Study Sites (1)

Biofortis Merieux Nutrisciences

Saint-Herblain, 44800, France

RECRUITING

Study Officials

• Géraldine Krausz, PhD

  Givaudan France Naturals

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 11, 2021
• Study Start: November 22, 2021
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

FR (1)