Clinical trial NCT04511052: Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women
Official title: Probiotics for Enhanced Tissue Carotenoid Status: a Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carotenoid Status
Gut Microbiome
Skin Health
Keywords: Carotenoid
Microbiome
Skin
Color
Plasma
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Lallemand Health Solutions
First posted: 2020-08-12
Enrollment: 37
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in skin yellow color saturation measured by a spectrophotometer
timeFrame: Week 0, 5, and 10
Secondary outcomes:
measure: Changes in blood plasma carotenoid status
timeFrame: Week 0, 5, and 10
measure: Changes in yellow skin color saturation measured by image analysis
timeFrame: Week 0, 5, and 10
measure: Changes in fecal microbial composition
timeFrame: Week -2, 0, 5, and 10
measure: Changes in recovery of probiotic strain
timeFrame: Week -2, 0, 5, and 10
measure: Changes in skin hydration
timeFrame: Week 0, 5, and 10
measure: Changes in skin elasticity
timeFrame: Week 0, 5, and 10
measure: Changes in skin trans-epidermal water loss
timeFrame: Week 0, 5, and 10
measure: Changes in facial skin wrinkling
timeFrame: Week 0, 5, and 10
measure: Changes in plasma interleukin 1β (IL-1β) levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma interleukin-6 (IL-6) levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma interleukin-8 (IL-8) levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma tumor necrosis factor- α (TNF-α) levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma F-2 isoprostane levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma progesterone levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma estradiol levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma testosterone levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma cortisol levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma cholesterol levels
timeFrame: Week 0, 5, and 10
measure: Changes in plasma antioxidant capacity
timeFrame: Week 0, 5, and 10
measure: Changes in Vitamin A status
timeFrame: Week 0, 5, and 10
measure: Changes in perceived health and attractiveness
timeFrame: Week 0, 5, and 10
measure: Changes in quality of life assessed by SF-36 questionnaire
timeFrame: Week 0, 5, and 10
Other outcomes:
Locations:
city: Sainte-Anne-de-Bellevue
country: Canada
facility: Mary Emily Clinical Nutrition Research Unit (7 rue maple)
state: Quebec
Study officials:
References: