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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
109
1 capsule daily of probiotic with niacin supplementation for 8 weeks
1 capsule daily of probiotic without niacin supplementation for 8 weeks
1 capsule daily of placebo supplementation for 8 weeks
Oriflame Cosmetics
Stockholm, Sweden
Change from Baseline Skin Features (pores, wrinkles, colour, pigmentation and redness) at 8 weeks
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.
Time frame: Day 0, Day 56
Change from Baseline Skin Features (shininess) at 8 weeks
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)
Time frame: Day 0, Day 56
Change from Baseline Skin Features (spot size and color) at 8 weeks
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
Time frame: Day 0, Day 56
Change from Baseline Superficial Hydration at 8 weeks
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)
Time frame: Day 0, Day 56
Change from Baseline Skin Barrier Integrity at 8 weeks
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
Time frame: Day 0, Day 56
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Change from Baseline Sebum Level at 8 weeks
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
Time frame: Day 0, Day 56
Change from Baseline Antioxidant Level at 8 weeks
Skin feature: Antioxidant level Site: Temple/Cheek area Procedure: BioZoom Unit: Arbitrary unit (AU)
Time frame: Day 0, Day 56
Change from Baseline Microbial Level at 8 weeks
Skin feature: Microbial Level Site: Forehead Procedure: Damp cotton swab Unit: Microbial count by sequencing
Time frame: Day 0, Day 56
Questionnaire on general health and wellbeing
Subjective measurements of self-rated health aspects using a 9-point hedonic scale (extremely good to extremely bad) at baseline, mid and end of study to access intervention effects
Time frame: Day 0, Day 28, Day 56