Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women (ProCar)

McGill University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Gut Microbiome; Carotenoid Status; Skin Health

Treatments: Other: Placebo; Dietary Supplement: Carotenoid supplement; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04511052

IT15250 (Other Grant/Funding Number)

A12-M57-19B

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy non-menopausal or non-perimenopausal women,
2. 30-50 years of age,
3. BMI of 18.5 - 29.9 kg/m2,
4. Access to a smartphone that has a camera and iOS 11.0 or Android 4.2 and up,
5. Visible fine to moderate wrinkles on the face (e.g. forehead, crow's feet area, etc.),
6. Fitzpatrick scale of types I, II, & III
7. Urine pregnancy test of negative
8. Willing to maintain current physical activity and dietary habits
9. Willing to refrain from taking natural health products containing carotenoids (beta-carotene, lutein, lycopene, etc.)
10. 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,
11. Willing to apply the moisturizer provided on every day throughout the study upon admission to the study (about -2 weeks),
12. 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),
13. Able to understand and comply with requirements of the study (e.g. complete all clinical visits, questionnaires, records, and diaries),
14. Able to provide a written informed consent.

Exclusion criteria

1. Known immunodeficiency (immuno-compromised and immuno-suppressed participant; e.g. AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participant),

2. Known chronic or acute illness (e.g. hepatitis, diabetes, high blood pressure, jaundice, etc.), unless under control via medication,

3. 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),

4. Known chronic or acute skin condition on the face (e.g. eczema, psoriasis, severe acne, rosacea, etc.),

5. Facial surgery (e.g. lifting, facial rejuvenation) or chemical treatment (e.g. Botox injection) within 5 years before study start,

6. Frequent tanning salons, use tanning products, or foresee high exposure to the sun during the study,

7. Tattoos on the face or palms of the hands,

8. Milk, soy or yeast allergy,

9. Routine use of dietary supplements that may interfere with outcomes measured (e.g. anti-oxidant, anti-inflammatory, herbal),

10. Use of probiotic products in the past 2 weeks (may be eligible to participate after a 2-week washout period),

11. Allergy to any of the ingredients contained in the moisturizer provided,

12. 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),

13. Current smoker (tobacco or cannabis),

14. Excessive alcohol consumption (>1 drink/day),

15. Drug abuse or addiction,

16. Bleeding/blood disorder

17. Psychological disorder

18. Currently enrolled in another trial

19. 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),

20. 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

21. Participation in a similar study within 3 months of the screening visit.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups, including a placebo group

Carotenoid + Probiotic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Dietary Supplement: Carotenoid supplement

Carotenoid + Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Carotenoid supplement

Other: Placebo