NCT04841694Unknown不适用
Prospective Randomized Double-Blind Placebo Controlled Study of Oral Probiotics on the Shift of Gut Microbiome and Skin Carotenoid Levels
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Carotenoid Levels
研究概览
简要总结
The purpose of this study is to determine how probiotics affects circulating carotenoid levels.
详细描述
Certain probiotic strains are rich in the production of carotenoids. This study will evaluate if probiotic supplementation with a carotenoid rich strain will augment circulating carotenoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 40+
- •Must be willing to comply with all protocol requirements
- •Must be willing to have flash photo facial images taken with the imaging systems
- •Fitzpatrick skin type II, III, or IV
排除标准
- •Any systemic or antibiotics (injected or oral) within 6 months of starting study
- •Any topical antibiotic or Vitamin A within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or vitamin A ingredient.
- •Any oral probiotic or prebiotic supplementation within past 1 month at the discretion of the investigator.
- •Limit total fruit and vegetable intake to 2.5 servings (1 serving=1 cup) per day of high carotenoid foods. High carotenoid foods include spinach, summer squash, carrots, citrus fruits, celery, kale, tomatoes, and cantaloupe
- •Subjects must have no history of malignancy or cancer (excluding skin cancer unless there is a history of metastasis) or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis)
- •Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results
- •Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating.
- •Is participating in a concurrent intervention based clinical research study
- •Those with BMI higher than 35 kg/m²
- •Commencement of a new diet (such as the ketogenic diet) or supplements within the 1 month prior to initiating participation, at the discretion of the investigator.
- •Is participating in or has participated in a intervention based facial study at this or any other facility in the past 2 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
- •Has a skin disease on face that will interfere with image collection and assessment in the opinion of the investigator
- •Refusal to shave or remove facial hair that may interfere with image collection and assessment.
- •Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, sun tanning, or artificial tanning.
- •Known allergy or irritation to the supplement utilized in the study
- •Persons unwilling to avoid sun exposure to the inner forearm
- •Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
- •Cutaneous photosensitivity at wavelengths of 400-450 nm
- •Porphyria or known allergies to porphyrins
- •Prisoners
- •Adults unable to consent
结局指标
主要结局
Carotenoid Levels
时间窗: 5 weeks
Change in skin carotenoid level and blood carotenoid level with supplementation
次要结局
- Assessment of GI related gas and constipation(Week 6)
- Shift in facial redness- image based(Week 6)
- Gut Microbiome Changes(Week 5)
- Shift in facial pigmentation - image based(Week 6)
- Carotenoid Levels(5 weeks)
- Protection against blue light exposure induced change in skin color(Weeks 6)
研究者
Raja Sivamani
Principal Investigator
Integrative Skin Science and Research
研究点 (2)
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