Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Change from Baseline Antioxidant Level at 8 weeks
研究概览
简要总结
The goal of this double-blind randomized clinical trial is to investigate the effects on the skin from oral intake of probiotic supplements in healthy adult men and women. The main questions it aims to answer are: • Will probiotic supplementation result in beneficial changes to different skin parameters? • Will probiotic supplementation result in alterations in the skin microbiome? Participants will consume the study product daily for 8 weeks and come in for skin measurements at baseline and after 8 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Fully informed with the study specifications.
- •Signed consent form prior to commencing the study.
- •Motivated for participation in the study, and available over the full test period.
- •Healthy skin on the face (i.e., absence of psoriasis, eczemas, erythema, oedema, scars, wounds, lesions, or any other type of inflammatory or autoimmune skin condition).
- •Healthy gut (i.e., absence of irritable bowel diseases (IBD), irritable bowel syndrome (IBS), or any other type of inflammatory or autoimmune gut condition).
- •No supplementation with probiotic, prebiotic or synbiotic products 2 weeks prior and/or during the whole study period.
- •No supplementation with niacin (vitamin B3) 2 weeks prior and/or during the whole study period.
- •No significant change in skin care routine (such as injectable cosmetics, skin tanning, etc.) throughout the whole study period.
- •No significant change in the diet throughout the whole study period.
排除标准
- •Not fulfilling the inclusion criteria.
- •Pregnant or lactating 3 months prior to study commencement or during the study.
- •Women post menopause.
- •Use of antibiotics at least 4 weeks prior and/or during the whole study period.
- •Sun-tanned facial skin.
- •Participating in another clinical study that could interfere with the present research.
- •Presented health problems or specific medications that could adversely affect the study outcome.
- •Presented any cutaneous hypersensitivity or allergy to cosmetic products.
- •Major surgery on the face one year prior to study commencement.
- •Applied any cleansing, topical or moisturizing product (including all make-up products) to the measurement area the morning of assessments at Oriflame Cosmetic AB.
- •Exposure to artificial UV light and/or to the sun during the study.
- •Special diets (vegan, low carbohydrate, weight loss diet, etc.).
- •Significant change in weight one month before or during the study period.
结局指标
主要结局
Change from Baseline Antioxidant Level at 8 weeks
时间窗: Day 0, Day 56
Skin feature: Antioxidant level Site: Temple/Cheek area Procedure: BioZoom Unit: Arbitrary unit (AU)
Change from Baseline Skin Features (pores, wrinkles, colour, pigmentation and redness) at 8 weeks
时间窗: Day 0, Day 56
Skin features: Pores, wrinkles, colour, pigmentation and redness Site: Cheek, Temple and Forehead - 3 measurement per area. Thus 9 in total. Procedure: As per WI091 Standard use of the Miravex Antera 3D Camera V1 and TM089 Skin features measurements Using the Antera 3D V1 Unit: Pores: volume (mm3), index, count, volume/count Wrinkles: overall size, depth (mm), width (mm), Texture: Average Roughness (Ra) Colour variation: DeltaE Pigmentation/redness: average level (concentration per unit area), color variation.
Change from Baseline Skin Features (shininess) at 8 weeks
时间窗: Day 0, Day 56
Skin features: Shininess Site: Entire face Procedure: As per WI044 Standard use of the VISIA-CR2.2 V3 and TM066 Determination Of Skin Brightness Using The Image Pro Plus Shine Macro Test V2 Unit: Arbitrary unit (AU)
Change from Baseline Skin Features (spot size and color) at 8 weeks
时间窗: Day 0, Day 56
Skin features: Spot size and color Site: Entire face Procedure: As per WI044 Standard use of the VISIA-CR2.2 V3 and TM038 Clinical Determination of Spot Size and Colour Unit: Color = L\*a\*b\*, Delta E Spot size: volume, count
Change from Baseline Superficial Hydration at 8 weeks
时间窗: Day 0, Day 56
Skin feature: Superficial hydration Site: Upper cheek - triplicate measurements Procedure: As per WI003 Standard use of the Corneometer CM 825 to measure skin moisture V4. Unit: Arbitrary unit (AU)
Change from Baseline Skin Barrier Integrity at 8 weeks
时间窗: Day 0, Day 56
Skin feature: Skin barrier integrity Site: Upper cheek - single measurement Procedure: As per WI094 Standard Use of the Delfin Vapometer for Skin Barrier Measurements V1. Unit: g/m2h
Change from Baseline Microbial Level at 8 weeks
时间窗: Day 0, Day 56
Skin feature: Microbial Level Site: Forehead Procedure: Damp cotton swab Unit: Microbial count by sequencing
Change from Baseline Sebum Level at 8 weeks
时间窗: Day 0, Day 56
Skin feature: Sebum level Site: Forehead - triplicate measurements Procedure: As per WI005 Standard use of the Sebumeter SM 815 \& MPA 5 to Measure Skin Sebum Levels V2. Unit: µg/cm2
次要结局
- Questionnaire on general health and wellbeing(Day 0, Day 28, Day 56)