Healthy SubjectB-4-ImmuneNCT05117385
The Effect of the Consumption of 4 Botanical Extracts on Immunity in Healthy Adults (B-4-Immune)
A study testing Botanical extract in people with Healthy Subject and Immunity, run by Givaudan France Naturals at 1 site in France.
Trial summary
This study will evaluate the capacity of botanical extracts to modulate immune mechanisms compared to a placebo group in healthy volunteers. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject, Immunity
- What is being tested?
- Botanical extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2021to 18 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Biofortis Merieux Nutrisciences
Saint-Herblain, 44800
Marion Ligner, marion.ligner@biofortis.fr
Isabelle Métreau, PhD, MD
About this study
Official title: The Effect of the Consumption of 4 Botanical Extracts (Acerola, Panax Ginseng, Echinacea, Quillaja) on the Innate and Adaptive Immune Response in Healthy Adults: a Pilot Randomized Placebo-controlled Clinical Trial
This study will evaluate the capacity of botanical extracts to modulate immune mechanisms compared to a placebo group in healthy volunteers.
Read the detailed description
In this ex-vivo pilot study, healthy volunteers will consume extracts during 28 days and blood will be sampled at baseline and end of study. The purpose of this study is to evaluate the ex vivo immune responses with and without stimulation after consumption of botanical extracts and identify the main mechanisms involved. The effect of the consumption of 4 botanical extracts on the quality of life in healthy adults compared to placebo will be also analyzed.
- Conditions
- Healthy Subject, Immunity
- Being tested
- Botanical extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botanical extractDietary supplement
1 capsule per day
| Study group | Role | What they receive |
|---|---|---|
| Acerola | Experimental | dietary supplement : acerola extract self administrated by mouth for 28 days
1 capsule per day Receives: Dietary Supplement: Botanical extract |
| Panax ginseng extract | Experimental | dietary supplement : panax ginseng extract self administrated by mouth for 28 days
1 capsule per day Receives: Dietary Supplement: Botanical extract |
| Echinacea extract | Experimental | dietary supplement : echinacea extract self administrated by mouth for 28 days
1 capsule per day Receives: Dietary Supplement: Botanical extract |
| Quillaja extract | Experimental | dietary supplement : quillaja extract self administrated by mouth for 28 days
1 capsule per day Receives: Dietary Supplement: Botanical extract |
| Maltodextrin | Placebo comparator | dietary supplement : maltodextrin supplement self administrated by mouth for 28 days
1 capsule per day Receives: Dietary Supplement: Botanical extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 28 days
2. Variation of quality of life before and after 28 days of consumption of each botanical extract compared to placebo
Assessed by the SF-12-v2 (Short-Form Health Survey version 2) questionnaire. it is a generic patient-reported measure of health status that provides summary scores of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start22 Nov 2021
- Primary completion18 Jul 2022 (estimated)
- Study completion18 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Givaudan France Naturals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Responsible party
- Sponsor
- Investigators
- Géraldine Krausz, PhD, Study director, Givaudan France Naturals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117385
- Sponsor's protocol ID
- 2021-A01973-38
- Acronym
- B-4-Immune
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Consumption of 4 Botanical Extracts (Acerola, Panax Ginseng, Echinacea, Quillaja) on the Innate and Adaptive Immune Response in Healthy Adults: a Pilot Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05117385
- Acronym / sponsor ID
- B-4-Immune / 2021-A01973-38
- Conditions
- Healthy Subject, Immunity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Givaudan France NaturalsIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Mérieux NutriSciences
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 18 Jul 2022 (estimated)
- Study completion
- 18 Jul 2022 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the capacity of botanical extracts to modulate immune mechanisms compared to a placebo group in healthy volunteers.
Detailed description
In this ex-vivo pilot study, healthy volunteers will consume extracts during 28 days and blood will be sampled at baseline and end of study. The purpose of this study is to evaluate the ex vivo immune responses with and without stimulation after consumption of botanical extracts and identify the main mechanisms involved. The effect of the consumption of 4 botanical extracts on the quality of life in healthy adults compared to placebo will be also analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Acerola | Experimental | Dietary Supplement: Botanical extractdietary supplement : acerola extract self administrated by mouth for 28 days 1 capsule per day |
| Panax ginseng extract | Experimental | Dietary Supplement: Botanical extractdietary supplement : panax ginseng extract self administrated by mouth for 28 days 1 capsule per day |
| Echinacea extract | Experimental | Dietary Supplement: Botanical extractdietary supplement : echinacea extract self administrated by mouth for 28 days 1 capsule per day |
| Quillaja extract | Experimental | Dietary Supplement: Botanical extractdietary supplement : quillaja extract self administrated by mouth for 28 days 1 capsule per day |
| Maltodextrin | Placebo comparator | Dietary Supplement: Botanical extractdietary supplement : maltodextrin supplement self administrated by mouth for 28 days 1 capsule per day |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botanical extract1 capsule per day | Dietary supplement | Acerola, Echinacea extract, Maltodextrin, Panax ginseng extract, Quillaja extract |
Primary outcome
Ex vivo Immune blood cell response after challenges at baseline (before supplementation) and after 28 days of each botanical consumption compared to placebo
Time frame: 28 days
Innate immunity like response and adaptative cell activation
2 secondary outcomes
1. Frequency of innate and adaptative immune cell before and after 28 days of consumption of each botanical extract compared to placebo
Time frame: 28 days
2. Variation of quality of life before and after 28 days of consumption of each botanical extract compared to placebo
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Géraldine Krausz, PhD study director
Givaudan France Naturals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botanical extract in people with Healthy Subject and Immunity, run by Givaudan France Naturals at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Géraldine Krausz, PhD (+33 7 76 32 52 24, geraldine.krausz@givaudan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ex vivo Immune blood cell response after challenges at baseline (before supplementation) and after 28 days of each botanical consumption compared to placebo (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.