Carotenoid StatusPhase 1/2ProCarNCT04511052
Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women
A Phase 1/2 study testing Probiotic and Carotenoid supplement in people with Carotenoid Status and Gut Microbiome, run by McGill University at 1 site in Canada.
Trial summary
Carotenoids are yellow-orange fat soluble plant pigments primarily obtained from the diet that serve as an accurate biomarker for fruit and vegetable intake. Carotenoids have demonstrated antioxidant, anti-inflammatory, and anti-obesogenic properties among others. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Carotenoid Status, Gut Microbiome, Skin Health
- What is being tested?
- Probiotic and Carotenoid supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 13 Sep 2022
- Phase
- Phase 1/2
- 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 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-menopausal or non-perimenopausal women,
- 30-50 years of age,
- BMI of 18.5 - 29.9 kg/m2,
- Access to a smartphone that has a camera and iOS 11.0 or Android 4.2 and up,
- Visible fine to moderate wrinkles on the face (e.g. forehead, crow's feet area, etc.),
- Fitzpatrick scale of types I, II, \& III
Show all 14Show fewer
- Urine pregnancy test of negative
- Willing to maintain current physical activity and dietary habits
- Willing to refrain from taking natural health products containing carotenoids (beta-carotene, lutein, lycopene, etc.)
- Willing to discontinue consumption of probiotic supplements and food containing added probiotics (e.g. yogurts with live, active cultures or supplements) or fermented foods (e.g. Kefir, pickles, etc.) upon screening and for the duration of the study,
- Willing to apply the moisturizer provided on every day throughout the study upon admission to the study (about -2 weeks),
- Willing to refrain from using any cream (including the moisturizer provided) and makeup on the face for study visits and photo capture (face, eyes and lips),
- Able to understand and comply with requirements of the study (e.g. complete all clinical visits, questionnaires, records, and diaries),
- Able to provide a written informed consent.
Who cannot join
- Known immunodeficiency (immuno-compromised and immuno-suppressed participant; e.g. AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participant),
- Known chronic or acute illness (e.g. hepatitis, diabetes, high blood pressure, jaundice, etc.), unless under control via medication,
- History of illness or use of any type of drug that may interfere with the investigational product or intervention (e.g. antibiotics) within 1 month of screening (may be eligible to participate after a 2-week washout period),
- Known chronic or acute skin condition on the face (e.g. eczema, psoriasis, severe acne, rosacea, etc.),
- Facial surgery (e.g. lifting, facial rejuvenation) or chemical treatment (e.g. Botox injection) within 5 years before study start,
- Frequent tanning salons, use tanning products, or foresee high exposure to the sun during the study,
Show all 27Show fewer
- Tattoos on the face or palms of the hands,
- Milk, soy or yeast allergy,
- Routine use of dietary supplements that may interfere with outcomes measured (e.g. anti-oxidant, anti-inflammatory, herbal),
- Use of probiotic products in the past 2 weeks (may be eligible to participate after a 2-week washout period),
- Allergy to any of the ingredients contained in the moisturizer provided,
- Use of antiaging creams containing retinol, glycolic acid, Coenzyme Q, etc. (may be eligible to participate after a 2 weeks washout period upon admission to the study),
- Current smoker (tobacco or cannabis),
- Excessive alcohol consumption (>1 drink/day),
- Drug abuse or addiction,
- Bleeding/blood disorder
- Psychological disorder
- Currently enrolled in another trial
- Positive pregnancy test in women of child-bearing potential; breast-feeding or planning on becoming pregnant during the course of the study (determined by a pregnancy test performed at the screening visit),
- Women of child-bearing potential not using effective contraception which include:
- Hormonal contraceptives including combined oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormonal implants
- Intrauterine devices (IUD) or Intrauterine system (IUS)
- Tubal ligation
- Vasectomy of partner
- Barrier method (condom or occlusive cap with spermicide)
- Abstinence
- Participation in a similar study within 3 months of the screening visit.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Mary Emily Clinical Nutrition Research Unit (7 rue maple)
Sainte-Anne-de-Bellevue, Quebec, H9X 2E3
About this study
Official title: Probiotics for Enhanced Tissue Carotenoid Status: a Double-blind, Randomized, Controlled Trial
Carotenoids are yellow-orange fat soluble plant pigments primarily obtained from the diet that serve as an accurate biomarker for fruit and vegetable intake. Carotenoids have demonstrated antioxidant, anti-inflammatory, and anti-obesogenic properties among others. Excess carotenoids are deposited in the skin for storage where they protect against UV skin damage and contribute to improvements in skin health (i.e., decrease the appearance of wrinkles). However, carotenoid status is linked to bioavailability and absorption, which has a high inter-individual variability. It has been hypothesized that inter-individual variations are related to the diversity of gut microbiota.
The aim of the present study is to determine whether probiotic supplementation can enhance carotenoid status and responsiveness to carotenoid-mediated changes in blood and skin from intake of a supplement containing mixed forms of carotenoids in pre-menopausal women.
- Conditions
- Carotenoid Status, Gut Microbiome, Skin Health
- Being tested
- Probiotic, Placebo, Carotenoid supplement
- Keywords
- Carotenoid, Microbiome, Skin, Color, Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Daily intake of 10 x 10^9 CFU of a proprietary strain for a total duration of 10 weeks
PlaceboOther
1 capsule daily containing the same carrier material that is similar in size, shape and taste to the probiotic, for a duration of 10 weeks
Carotenoid supplementDietary supplement
1 capsule daily containing ~20 mg of total carotenoids for a total duration of 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Carotenoid + Probiotic | Experimental | Carotenoid: 1 capsule daily of a mixed carotenoid (~ 20 mg total carotenoids) supplement
Probiotic: 1 capsule daily containing 10 x 10^9 CFU of a proprietary strain
Total duration: 10 weeks Receives: Dietary Supplement: Probiotic; Dietary Supplement: Carotenoid supplement |
| Carotenoid + Placebo | Placebo comparator | Carotenoid: 1 capsule daily of a mixed carotenoid (~ 20 mg total carotenoids) supplement
Placebo: 1 capsule daily containing the same carrier material of the probiotic, that is also similar in size, shape, and taste.
Total duration: 10 weeks Receives: Other: Placebo; Dietary Supplement: Carotenoid supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skin yellow color saturation measured by a spectrophotometer
Average b* value (yellow coloration designated by the CIELab color space) measured from the palm and forehead by spectrophotometry
Measured: Week 0, 5, and 10
Secondary outcomes (23)
Changes in blood plasma carotenoid status
Blood plasma HPLC or LC-MS analysis
Measured: Week 0, 5, and 10
Changes in yellow skin color saturation measured by image analysis
Average b* value (yellow coloration designated by the CIELab color space) measured by image analysis of the palm and forehead
Measured: Week 0, 5, and 10
Changes in fecal microbial composition
16s rRNA sequencing
Measured: Week -2, 0, 5, and 10
Changes in recovery of probiotic strain
16s rRNA qPCR
Measured: Week -2, 0, 5, and 10
Changes in skin hydration
Measured using a Courage + Khazaka probe system
Measured: Week 0, 5, and 10
Changes in skin elasticity
Measured using the Tewameter probe from Courage + Khazaka probe system
Measured: Week 0, 5, and 10
Changes in skin trans-epidermal water loss
Measured using a Courage + Khazaka probe system
Measured: Week 0, 5, and 10
Changes in facial skin wrinkling
Images of participants will be individually rated by two trained specialists based on the skin aging atlas 1 - Caucasian type book at four different regions: forehead, crow's feet, nasolabial fold, and upper lip
Measured: Week 0, 5, and 10
Changes in plasma interleukin 1β (IL-1β) levels
Assessed with MILLIPLEX MAP Human High Sensitivity T Cell Panel - Immunology Multiplex Assay.
Measured: Week 0, 5, and 10
Changes in plasma interleukin-6 (IL-6) levels
Assessed with MILLIPLEX MAP Human High Sensitivity T Cell Panel - Immunology Multiplex Assay.
Measured: Week 0, 5, and 10
Changes in plasma interleukin-8 (IL-8) levels
Assessed with MILLIPLEX MAP Human High Sensitivity T Cell Panel - Immunology Multiplex Assay
Measured: Week 0, 5, and 10
Changes in plasma tumor necrosis factor- α (TNF-α) levels
Assessed with MILLIPLEX MAP Human High Sensitivity T Cell Panel - Immunology Multiplex Assay.
Measured: Week 0, 5, and 10
Changes in plasma 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels
Assessed via LC-MS
Measured: Week 0, 5, and 10
Changes in plasma F-2 isoprostane levels
Assessed via LC-MS
Measured: Week 0, 5, and 10
Changes in plasma progesterone levels
Analysis using MILLIPLEX MAP Multi-Species Hormone Magnetic Bead Panel
Measured: Week 0, 5, and 10
Changes in plasma estradiol levels
Analysis using MILLIPLEX MAP Multi-Species Hormone Magnetic Bead Panel
Measured: Week 0, 5, and 10
Changes in plasma testosterone levels
Analysis using MILLIPLEX MAP Multi-Species Hormone Magnetic Bead Panel
Measured: Week 0, 5, and 10
Changes in plasma cortisol levels
Analysis using MILLIPLEX MAP Multi-Species Hormone Magnetic Bead Panel
Measured: Week 0, 5, and 10
Changes in plasma cholesterol levels
Using a colorimetric assay
Measured: Week 0, 5, and 10
Changes in plasma antioxidant capacity
Measured using the 2,2'-azino-bis-3-ethylbenzthiazoline-6-sulfonic acid (ABTS) assay
Measured: Week 0, 5, and 10
Changes in Vitamin A status
Plasma HPLC analysis
Measured: Week 0, 5, and 10
Changes in perceived health and attractiveness
A perception trial is a validated method used to determine the attractiveness preferences of participants (Lefevre \& Perrett, 2015). Images of participants from the intervention trial will be sent to the Department of Psychology at McGill University, where the laboratory coordinator will set up an electronic survey that will display randomized sets of images from the same intervention participant at all timepoints (week 0, 5, and 10) of the intervention, in randomized order of presentation (left and right). A separate group of 60 participants will be recruited to participate in the perception trial and assess the images of the intervention participants. These participants will be trained using a few sample photos and then will be instructed to choose the most attractive and healthy looking face in a forced-choice paradigm for each comparison presented in the electronic survey.
Measured: Week 0, 5, and 10
Changes in quality of life assessed by SF-36 questionnaire
The short form 36-Item Health Survey 1.0 Questionnaire is a validated questionnaire that will be used to assess QoL as a recent study (Valler-Colomer et al., 2019) demonstrated a consistent association between higher QoL indicators and particular gut microbiota profiles (butyrate-producing Faecalibacterium and Coprococcus bacteria). This survey consists of 36 items that average together to indicate eight scale scores for various health indicators (e.g., emotional well-being, general health, etc.). Scores range from 0-100, with higher scores representing better health. Carotenoid supplementation has also demonstrated improvements in sub-optimal symptoms of physical and emotional health measured via various self-reported questionnaires (Stringham et al., 2018).
Measured: Week 0, 5, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Nov 2021
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotenoid StatusStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Principal investigator, Stan Kubow, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511052
- Sponsor's protocol ID
- A12-M57-19B
- Other IDs
- IT15250
- Acronym
- ProCar
- Status last verified
- May 2025
- First submitted
- 29 Jul 2020
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roldos LG, Iskandar MM, Oula ML, Piano A, Auger J, Tompkins TA, Khouri L, Binda S, Kubow S. Probiotics for Enhanced Tissue Carotenoid Status: A Double-Blind, Randomized Controlled Trial. J Nutr. 2026 Jul 10;156(9):101716. doi: 10.1016/j.tjnut.2026.101716. Online ahead of print.
PubMed 42431406
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Enhanced Tissue Carotenoid Status: a Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04511052
- Acronym / sponsor ID
- ProCar / A12-M57-19B
- Conditions
- Carotenoid Status, Gut Microbiome, Skin Health
- Keywords
- Carotenoid, Microbiome, Skin, Color, Plasma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 12 Aug 2020 (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.
Carotenoids are yellow-orange fat soluble plant pigments primarily obtained from the diet that serve as an accurate biomarker for fruit and vegetable intake. Carotenoids have demonstrated antioxidant, anti-inflammatory, and anti-obesogenic properties among others. Excess carotenoids are deposited in the skin for storage where they protect against UV skin damage and contribute to improvements in skin health (i.e., decrease the appearance of wrinkles). However, carotenoid status is linked to bioavailability and absorption, which has a high inter-individual variability. It has been hypothesized that inter-individual variations are related to the diversity of gut microbiota.
The aim of the present study is to determine whether probiotic supplementation can enhance carotenoid status and responsiveness to carotenoid-mediated changes in blood and skin from intake of a supplement containing mixed forms of carotenoids in pre-menopausal women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotenoid + Probiotic | Experimental | Dietary Supplement: Probiotic, Dietary Supplement: Carotenoid supplementCarotenoid: 1 capsule daily of a mixed carotenoid (~ 20 mg total carotenoids) supplement Probiotic: 1 capsule daily containing 10 x 10^9 CFU of a proprietary strain Total duration: 10 weeks |
| Carotenoid + Placebo | Placebo comparator | Other: Placebo, Dietary Supplement: Carotenoid supplementCarotenoid: 1 capsule daily of a mixed carotenoid (~ 20 mg total carotenoids) supplement Placebo: 1 capsule daily containing the same carrier material of the probiotic, that is also similar in size, shape, and taste. Total duration: 10 weeks |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy non-menopausal or non-perimenopausal women,
- 30-50 years of age,
- BMI of 18.5 - 29.9 kg/m2,
- Access to a smartphone that has a camera and iOS 11.0 or Android 4.2 and up,
- Visible fine to moderate wrinkles on the face (e.g. forehead, crow's feet area, etc.),
Key exclusion criteria (27 listed)
- Known immunodeficiency (immuno-compromised and immuno-suppressed participant; e.g. AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participant),
- Known chronic or acute illness (e.g. hepatitis, diabetes, high blood pressure, jaundice, etc.), unless under control via medication,
- History of illness or use of any type of drug that may interfere with the investigational product or intervention (e.g. antibiotics) within 1 month of screening (may be eligible to participate after a 2-week washout period),
- Known chronic or acute skin condition on the face (e.g. eczema, psoriasis, severe acne, rosacea, etc.),
- Facial surgery (e.g. lifting, facial rejuvenation) or chemical treatment (e.g. Botox injection) within 5 years before study start,
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 |
|---|---|---|
| ProbioticDaily intake of 10 x 10^9 CFU of a proprietary strain for a total duration of 10 weeks | Dietary supplement | Carotenoid + Probiotic |
| Placebo1 capsule daily containing the same carrier material that is similar in size, shape and taste to the probiotic, for a duration of 10 weeks | Other | Carotenoid + Placebo |
| Carotenoid supplement1 capsule daily containing ~20 mg of total carotenoids for a total duration of 10 weeks | Dietary supplement | Carotenoid + Placebo, Carotenoid + Probiotic |
Primary outcome
Changes in skin yellow color saturation measured by a spectrophotometer
Time frame: Week 0, 5, and 10
Average b* value (yellow coloration designated by the CIELab color space) measured from the palm and forehead by spectrophotometry
23 secondary outcomes
Changes in blood plasma carotenoid status
Time frame: Week 0, 5, and 10
Changes in yellow skin color saturation measured by image analysis
Time frame: Week 0, 5, and 10
Changes in fecal microbial composition
Time frame: Week -2, 0, 5, and 10
Changes in recovery of probiotic strain
Time frame: Week -2, 0, 5, and 10
Changes in skin hydration
Time frame: Week 0, 5, and 10
Changes in skin elasticity
Time frame: Week 0, 5, and 10
Changes in skin trans-epidermal water loss
Time frame: Week 0, 5, and 10
Changes in facial skin wrinkling
Time frame: Week 0, 5, and 10
Changes in plasma interleukin 1β (IL-1β) levels
Time frame: Week 0, 5, and 10
Changes in plasma interleukin-6 (IL-6) levels
Time frame: Week 0, 5, and 10
Changes in plasma interleukin-8 (IL-8) levels
Time frame: Week 0, 5, and 10
Changes in plasma tumor necrosis factor- α (TNF-α) levels
Time frame: Week 0, 5, and 10
Changes in plasma 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels
Time frame: Week 0, 5, and 10
Changes in plasma F-2 isoprostane levels
Time frame: Week 0, 5, and 10
Changes in plasma progesterone levels
Time frame: Week 0, 5, and 10
Changes in plasma estradiol levels
Time frame: Week 0, 5, and 10
Changes in plasma testosterone levels
Time frame: Week 0, 5, and 10
Changes in plasma cortisol levels
Time frame: Week 0, 5, and 10
Changes in plasma cholesterol levels
Time frame: Week 0, 5, and 10
Changes in plasma antioxidant capacity
Time frame: Week 0, 5, and 10
Changes in Vitamin A status
Time frame: Week 0, 5, and 10
Changes in perceived health and attractiveness
Time frame: Week 0, 5, and 10
Changes in quality of life assessed by SF-36 questionnaire
Time frame: Week 0, 5, and 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 42431406Roldos LG, Iskandar MM, Oula ML, Piano A, Auger J, Tompkins TA, Khouri L, Binda S, Kubow S. Probiotics for Enhanced Tissue Carotenoid Status: A Double-Blind, Randomized Controlled Trial. J Nutr. 2026 Jul 10;156(9):101716. doi: 10.1016/j.tjnut.2026.101716. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Probiotic and Carotenoid supplement in people with Carotenoid Status and Gut Microbiome, run by McGill University at 1 site in Canada.
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 14 inclusion and 27 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: finished, as of the sponsor's last update on 11 May 2025. 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 Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in skin yellow color saturation measured by a spectrophotometer (time frame: Week 0, 5, and 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04511052, which also lists 1 linked publication.
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 11 May 2025.