NCT04511052

Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women

Probiotics for Enhanced Tissue Carotenoid Status: a Double-blind, Randomized, Controlled Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: McGill University · Academic / Other
• Sex: Female
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Daily intake of 10 x 10\^9 CFU of a proprietary strain for a total duration of 10 weeks
OTHER	Placebo	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
DIETARY_SUPPLEMENT	Carotenoid supplement	1 capsule daily containing \~20 mg of total carotenoids for a total duration of 10 weeks

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2020-08-12
• Last updated: 2025-05-11

Locations

1 site across 1 country: Canada