Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women

NCT04511052 | Completed Phase 1

• 2 other identifiers: A12-M57-19BIT15250
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotenoid Status; Gut Microbiome; Skin Health

Keywords

Carotenoid; Microbiome; Skin; Color; Plasma

Outcome Measures

Primary Outcomes (1)

• 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

  Week 0, 5, and 10

Secondary Outcomes (23)

• Changes in blood plasma carotenoid status

  Week 0, 5, and 10

• Changes in yellow skin color saturation measured by image analysis

  Week 0, 5, and 10

• Changes in fecal microbial composition

  Week -2, 0, 5, and 10

• Changes in recovery of probiotic strain

  Week -2, 0, 5, and 10

• Changes in skin hydration

  Week 0, 5, and 10

Study Arms (2)

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

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

Other: Placebo; Dietary Supplement: Carotenoid supplement

Interventions

Probiotic DIETARY_SUPPLEMENT

Daily intake of 10 x 10\^9 CFU of a proprietary strain for a total duration of 10 weeks

Carotenoid + Probiotic

Placebo OTHER

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 + Placebo

Carotenoid supplement DIETARY_SUPPLEMENT

1 capsule daily containing \~20 mg of total carotenoids for a total duration of 10 weeks

Carotenoid + Placebo; Carotenoid + Probiotic

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy non-menopausal or non-perimenopausal women,
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• McGill University: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

Mary Emily Clinical Nutrition Research Unit (7 rue maple)

Sainte-Anne-de-Bellevue, Quebec, H9X 2E3, Canada

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 12, 2020
• Study Start: November 1, 2021
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)