HealthyNCT05699473
Bioavailability Study of Folate in Healthy Subjects
A study testing 5-MTHF glucosamine salt, 5-MTHF calcium salt 1 and 5-MTHF calcium salt 2 in people with Healthy, run by Lesaffre International at 1 site in France.
Trial summary
The aim of this prospective interventional study is to compare the bioavailability of the 6S-5-methyltetrahydrofolate (5-MTHF) glucosamine salt versus two other forms of 5- MTHF calcium salts by measuring serum 5-MTHF responses after a single ingestion of equivalent doses of the three folate forms in humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 5-MTHF glucosamine salt, 5-MTHF calcium salt 1 and 5-MTHF calcium salt 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2023to 6 May 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) ≥18 and ≤25Kg/m²,
- For women: menopausal without hormone replacement therapy (HRT) or with HRT started from more than 3 months or non-menopausal with a negative blood pregnancy test and using reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study,
- Good general and mental health within 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/her dated and signed informed consent form,
- Affiliated with a social security scheme,
- Agree to be registered on the subjects in biomedical research file.
- After V1 biological analysis the subjects will be eligible to the study on the following criteria:
- Adequate folate status (serum folate between 10 and 45nmol/L, erythrocyte (RBC) folate between 405 and 952 nmol/L),
Who cannot join
- Suffering from a metabolic disorder,
- Suffering from a severe chronic disease found to be inconsistent with the conduct of the study by the investigator,
- Suffering from diseases that could potentially interfere with folate absorption or metabolism,
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
- With a low venous capital of blood samples according to the investigator's opinion,
- Pregnant or was pregnant less than 6 months prior to the study, or lactating women or intending to become pregnant within 3 months ahead,
Show all 26Show fewer
- Under treatment or regular use of treatment or dietary supplement which could significantly affect folate status or other study parameter(s),
- Use of supplements containing folate (i.e. folic acid, 5-MTHF) the last 3 months,
- With significant change in lifestyle, food habits, physical activity or medications in the 3 months before the V1 visit or not agreeing to keep them unchanged throughout the study,
- With a current or planned in the next 3 months' specific diet (hyper or hypocaloric, vegan, vegetarian…) or stopped less than 3 months before the study,
- With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator,
- Consuming more than 2 standard drinks of alcoholic beverage daily for men and women or not agreeing to keep his alcohol consumption habits unchanged throughout the study.
- Smoking,
- Having a lifestyle deemed incompatible with the study according to the investigator including high level physical activity,
- Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- 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.
- Who made a blood donation in the 3 months before the V0 visit or intending to make it within 3 months ahead.
- After V1 biological analysis the subjects will be non-eligible to the study on the following criteria:
- Presence of anemia (hemoglobin<12g/dL in women and 13g/dL in men),
- Vitamin B12 levels (serum cobalamin <148pmol/L),
- Serum total homocysteine levels≥15µmol/L,
- Serum creatinine >0,96mg/dL for women and >1,21mg/dL for men,
- Control record (Glycaemia, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, GGT, ASAT, ALAT, Urea and CBC) with clinically significant abnormality according to the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Cross-over, Comparative Bioavailability Study of 3 Different Forms of Folate in Healthy Subjects
The aim of this prospective interventional study is to compare the bioavailability of the 6S-5-methyltetrahydrofolate (5-MTHF) glucosamine salt versus two other forms of 5- MTHF calcium salts by measuring serum 5-MTHF responses after a single ingestion of equivalent doses of the three folate forms in humans.
The hypothesis of this study is that the test products 5-MTHF glucosamine and calcium salts have equivalent bioavailabilities in serum 5-MTHF as measured by the area under the curve over a period of 24 hours (AUC0-24h) after consumption of a single dose of 5-MTHF (400μg).
Read more
Participants will receive a single dose of each of the following products separated by a 7-day wash-out period:
- 5-MTHF glucosamine salt
- 5-MTHF calcium salt 1
- 5-MTHF calcium salt 2
- Conditions
- Healthy
- Being tested
- 5-MTHF glucosamine salt, 5-MTHF calcium salt 1, 5-MTHF calcium salt 2
- Keywords
- folate, bioavailability, comparative study, single dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-MTHF glucosamine saltDietary supplement
Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) glucosamine salt
5-MTHF calcium salt 1Dietary supplement
Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) calcium salt, crystal form 1
5-MTHF calcium salt 2Dietary supplement
Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) calcium salt, crystal form 2
| Study group | Role | What they receive |
|---|---|---|
| 5-MTHF glucosamine | Experimental | 1 single dose (400µg) Receives: Dietary Supplement: 5-MTHF glucosamine salt |
| 5-MTHF calcium salt 1 | Experimental | 1 single dose (400µg) Receives: Dietary Supplement: 5-MTHF calcium salt 1 |
| 5-MTHF calcium salt 2 | Experimental | 1 single dose (400µg) Receives: Dietary Supplement: 5-MTHF calcium salt 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) 0-24 hours of serum 5-MTHF concentrations
Comparison of AUC0-24 hours of serum 5-MTHF concentrations between the 3 study products
Measured: 0-24 hours
Secondary outcomes (7)
Area under the curve (AUC) 0-24 hours of serum total folate concentrations
Comparison of AUC0-24 hours of serum total folate concentrations between the 3 study products
Measured: 0-24 hours
Area under the curve (AUC) 0-8 hours of serum 5-MTHF and total folate concentrations
Comparison of AUC0-8 hours of serum 5-MTHF and total folate concentrations between the 3 study products
Measured: 0-8 hours
Area under the curve (AUC) 0-infinity of serum 5-MTHF and total folate concentrations
Comparison of AUC0-infinity of serum 5-MTHF and total folate concentrations between the 3 study products
Measured: 0-24 hours
Peak plasma concentrations (Cmax) of serum 5-MTHF and total folate
Comparison of peak plasma concentrations (Cmax) of serum 5-MTHF and total folate between the 3 study products
Measured: 0-24 hours
Half-life time of serum 5-MTHF and total folate
Comparison of half-life time of serum 5-MTHF and total folate between the 3 study products
Measured: 0-24 hours
Mean Residence Time (MRT) of serum 5-MTHF and total folate
Comparison of Mean Residence Time (MRT) of serum 5-MTHF and total folate between the 3 study products
Measured: 0-24 hours
Area under the curve (AUC) 0-24 hours of serum 5-MTHF and total folate concentrations adjusted on sex
Comparison of AUC0-24 hours of serum 5-MTHF and total folate concentrations between the 3 study products after adjustment by sex
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start12 Jan 2023
- Primary completion6 May 2023
- Study completion6 May 2023
Why it stopped: Analytic issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, monocentric, double-blind, randomized, cross-over bioavailability study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis, Soladis
- Responsible party
- Sponsor
- Investigators
- Isabelle METREAU, MD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699473
- Sponsor's protocol ID
- PEC21152
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Cross-over, Comparative Bioavailability Study of 3 Different Forms of Folate in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05699473
- Acronym / sponsor ID
- PEC21152
- Conditions
- Healthy
- Keywords
- folate, bioavailability, comparative study, single dose
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Analytic issue
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis, Soladis
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 26 Jan 2023 (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.
The aim of this prospective interventional study is to compare the bioavailability of the 6S-5-methyltetrahydrofolate (5-MTHF) glucosamine salt versus two other forms of 5- MTHF calcium salts by measuring serum 5-MTHF responses after a single ingestion of equivalent doses of the three folate forms in humans.
The hypothesis of this study is that the test products 5-MTHF glucosamine and calcium salts have equivalent bioavailabilities in serum 5-MTHF as measured by the area under the curve over a period of 24 hours (AUC0-24h) after consumption of a single dose of 5-MTHF (400μg).
Participants will receive a single dose of each of the following products separated by a 7-day wash-out period:
- 5-MTHF glucosamine salt
- 5-MTHF calcium salt 1
- 5-MTHF calcium salt 2
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, monocentric, double-blind, randomized, cross-over bioavailability study
| Arm | Type | Receives |
|---|---|---|
| 5-MTHF glucosamine | Experimental | Dietary Supplement: 5-MTHF glucosamine salt1 single dose (400µg) |
| 5-MTHF calcium salt 1 | Experimental | Dietary Supplement: 5-MTHF calcium salt 11 single dose (400µg) |
| 5-MTHF calcium salt 2 | Experimental | Dietary Supplement: 5-MTHF calcium salt 21 single dose (400µg) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body Mass Index (BMI) ≥18 and ≤25Kg/m²,
- For women: menopausal without hormone replacement therapy (HRT) or with HRT started from more than 3 months or non-menopausal with a negative blood pregnancy test and using reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study,
- Good general and mental health within 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/her dated and signed informed consent form,
- Affiliated with a social security scheme,
Key exclusion criteria (26 listed)
- Suffering from a metabolic disorder,
- Suffering from a severe chronic disease found to be inconsistent with the conduct of the study by the investigator,
- Suffering from diseases that could potentially interfere with folate absorption or metabolism,
- With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
- With a low venous capital of blood samples according to the investigator's opinion,
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 |
|---|---|---|
| 5-MTHF glucosamine saltActive form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) glucosamine salt | Dietary supplement | 5-MTHF glucosamine |
| 5-MTHF calcium salt 1Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) calcium salt, crystal form 1 | Dietary supplement | 5-MTHF calcium salt 1 |
| 5-MTHF calcium salt 2Active form of folate defined as (6S) 5-methyltetrahydrofolate (5-MTHF) calcium salt, crystal form 2 | Dietary supplement | 5-MTHF calcium salt 2 |
Primary outcome
Area under the curve (AUC) 0-24 hours of serum 5-MTHF concentrations
Time frame: 0-24 hours
Comparison of AUC0-24 hours of serum 5-MTHF concentrations between the 3 study products
7 secondary outcomes
Area under the curve (AUC) 0-24 hours of serum total folate concentrations
Time frame: 0-24 hours
Area under the curve (AUC) 0-8 hours of serum 5-MTHF and total folate concentrations
Time frame: 0-8 hours
Area under the curve (AUC) 0-infinity of serum 5-MTHF and total folate concentrations
Time frame: 0-24 hours
Peak plasma concentrations (Cmax) of serum 5-MTHF and total folate
Time frame: 0-24 hours
Half-life time of serum 5-MTHF and total folate
Time frame: 0-24 hours
Mean Residence Time (MRT) of serum 5-MTHF and total folate
Time frame: 0-24 hours
Area under the curve (AUC) 0-24 hours of serum 5-MTHF and total folate concentrations adjusted on sex
Time frame: 0-24 hours
Results and safety
The study was stopped early (reason given: Analytic issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Isabelle METREAU, MD principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-MTHF glucosamine salt, 5-MTHF calcium salt 1 and 5-MTHF calcium salt 2 in people with Healthy, run by Lesaffre International 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 8 inclusion and 26 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: stopped early, as of the sponsor's last update on 5 Jan 2024. 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. 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?
The study was stopped early (reason given: Analytic issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) 0-24 hours of serum 5-MTHF concentrations (time frame: 0-24 hours). 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 5 Jan 2024.