Mary Emily Clinical Nutrition Research Unit (7 rue maple)
Sainte-Anne-de-Bellevue, Quebec, H9X 2E3, Canada
NCT Number: NCT04511052
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.
Looking for future studies?
Notify Me30 year–50 year
Female
Interventional
Phase 1 / Phase 2
Sainte-Anne-de-Bellevue, Quebec, H9X 2E3, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily intake of 10 x 10^9 CFU of a proprietary strain for a total duration of 10 weeks
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
1 capsule daily containing ~20 mg of total carotenoids for a total duration of 10 weeks
Time frame: Week 0, 5, and 10
Average b* value (yellow coloration designated by the CIELab color space) measured from the palm and forehead by spectrophotometry
Time frame: Week 0, 5, and 10
Blood plasma HPLC or LC-MS analysis
Time frame: Week 0, 5, and 10
Average b* value (yellow coloration designated by the CIELab color space) measured by image analysis of the palm and forehead
Time frame: Week -2, 0, 5, and 10
16s rRNA sequencing
Time frame: Week -2, 0, 5, and 10
16s rRNA qPCR
Time frame: Week 0, 5, and 10
Measured using a Courage + Khazaka probe system
Time frame: Week 0, 5, and 10
Measured using the Tewameter probe from Courage + Khazaka probe system
Time frame: Week 0, 5, and 10
Measured using a Courage + Khazaka probe system
Time frame: Week 0, 5, and 10
Images of participants will be individually rated by two trained specialists based on the skin aging atlas 1 - Caucasian type book at four different regions: forehead, crow's feet, nasolabial fold, and upper lip
Time frame: Week 0, 5, and 10
Assessed with MILLIPLEX MAP Human High Sensitivity T Cell Panel - Immunology Multiplex Assay.
Time frame: Week 0, 5, and 10
Assessed with MILLIPLEX MAP Human High Sensitivity T Cell Panel - Immunology Multiplex Assay.
Time frame: Week 0, 5, and 10
Assessed with MILLIPLEX MAP Human High Sensitivity T Cell Panel - Immunology Multiplex Assay
Time frame: Week 0, 5, and 10
Assessed with MILLIPLEX MAP Human High Sensitivity T Cell Panel - Immunology Multiplex Assay.
Time frame: Week 0, 5, and 10
Assessed via LC-MS
Time frame: Week 0, 5, and 10
Assessed via LC-MS
Time frame: Week 0, 5, and 10
Analysis using MILLIPLEX MAP Multi-Species Hormone Magnetic Bead Panel
Time frame: Week 0, 5, and 10
Analysis using MILLIPLEX MAP Multi-Species Hormone Magnetic Bead Panel
Time frame: Week 0, 5, and 10
Analysis using MILLIPLEX MAP Multi-Species Hormone Magnetic Bead Panel
Time frame: Week 0, 5, and 10
Analysis using MILLIPLEX MAP Multi-Species Hormone Magnetic Bead Panel
Time frame: Week 0, 5, and 10
Using a colorimetric assay
Time frame: Week 0, 5, and 10
Measured using the 2,2'-azino-bis-3-ethylbenzthiazoline-6-sulfonic acid (ABTS) assay
Time frame: Week 0, 5, and 10
Plasma HPLC analysis
Time frame: Week 0, 5, and 10
A perception trial is a validated method used to determine the attractiveness preferences of participants (Lefevre & Perrett, 2015). Images of participants from the intervention trial will be sent to the Department of Psychology at McGill University, where the laboratory coordinator will set up an electronic survey that will display randomized sets of images from the same intervention participant at all timepoints (week 0, 5, and 10) of the intervention, in randomized order of presentation (left and right). A separate group of 60 participants will be recruited to participate in the perception trial and assess the images of the intervention participants. These participants will be trained using a few sample photos and then will be instructed to choose the most attractive and healthy looking face in a forced-choice paradigm for each comparison presented in the electronic survey.
Time frame: Week 0, 5, and 10
The short form 36-Item Health Survey 1.0 Questionnaire is a validated questionnaire that will be used to assess QoL as a recent study (Valler-Colomer et al., 2019) demonstrated a consistent association between higher QoL indicators and particular gut microbiota profiles (butyrate-producing Faecalibacterium and Coprococcus bacteria). This survey consists of 36 items that average together to indicate eight scale scores for various health indicators (e.g., emotional well-being, general health, etc.). Scores range from 0-100, with higher scores representing better health. Carotenoid supplementation has also demonstrated improvements in sub-optimal symptoms of physical and emotional health measured via various self-reported questionnaires (Stringham et al., 2018).
McGill University
Other
Probiotics for Enhanced Tissue Carotenoid Status: a Double-blind, Randomized, Controlled Trial
Acronym: ProCar
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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