NCT04511052已完成1 期
Probiotics for Enhanced Tissue Carotenoid Status: a Double-blind, Randomized, Controlled Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Changes in skin yellow color saturation measured by a spectrophotometer
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in skin yellow color saturation measured by a spectrophotometer
时间窗: Week 0, 5, and 10
Average b\* value (yellow coloration designated by the CIELab color space) measured from the palm and forehead by spectrophotometry
次要结局
- Changes in recovery of probiotic strain(Week -2, 0, 5, and 10)
- Changes in skin hydration(Week 0, 5, and 10)
- Changes in plasma cholesterol levels(Week 0, 5, and 10)
- Changes in yellow skin color saturation measured by image analysis(Week 0, 5, and 10)
- Changes in blood plasma carotenoid status(Week 0, 5, and 10)
- Changes in fecal microbial composition(Week -2, 0, 5, and 10)
- Changes in skin elasticity(Week 0, 5, and 10)
- Changes in skin trans-epidermal water loss(Week 0, 5, and 10)
- Changes in facial skin wrinkling(Week 0, 5, and 10)
- Changes in plasma interleukin 1β (IL-1β) levels(Week 0, 5, and 10)
- Changes in plasma interleukin-6 (IL-6) levels(Week 0, 5, and 10)
- Changes in plasma progesterone levels(Week 0, 5, and 10)
- Changes in plasma interleukin-8 (IL-8) levels(Week 0, 5, and 10)
- Changes in plasma tumor necrosis factor- α (TNF-α) levels(Week 0, 5, and 10)
- Changes in plasma 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels(Week 0, 5, and 10)
- Changes in plasma F-2 isoprostane levels(Week 0, 5, and 10)
- Changes in plasma estradiol levels(Week 0, 5, and 10)
- Changes in plasma testosterone levels(Week 0, 5, and 10)
- Changes in plasma cortisol levels(Week 0, 5, and 10)
- Changes in Vitamin A status(Week 0, 5, and 10)
- Changes in perceived health and attractiveness(Week 0, 5, and 10)
- Changes in quality of life assessed by SF-36 questionnaire(Week 0, 5, and 10)
- Changes in plasma antioxidant capacity(Week 0, 5, and 10)
研究者
Stan Kubow
Associate Professor
McGill University
研究点 (2)
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