Status:
COMPLETED
Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women
Lead Sponsor:
McGill University
Collaborating Sponsors:
Lallemand Health Solutions
Conditions:
Carotenoid Status
Gut Microbiome
Eligibility:
FEMALE
30-50 years
Phase:
PHASE1
PHASE2
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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,
- 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.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04511052
Start Date
November 1 2021
End Date
September 13 2022
Last Update
May 11 2025
Active Locations (1)
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1
Mary Emily Clinical Nutrition Research Unit (7 rue maple)
Sainte-Anne-de-Bellevue, Quebec, Canada, H9X 2E3