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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic with niacin and berry extract | Experimental |
| |
| Probiotic without niacin and berry extract | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic with niacin and berry extract | Dietary Supplement | 1 capsule daily of probiotic with niacin supplementation for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | 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 | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0, Day 28, Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabella Lee | Global Senior Nutritional Scientist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oriflame Cosmetics | Stockholm | 11226 | Sweden |
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| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D009525 | Niacin |
| D005638 | Fruit |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Probiotic without niacin and berry extract | Dietary Supplement | 1 capsule daily of probiotic without niacin supplementation for 8 weeks |
|
| Placebo | Dietary Supplement | 1 capsule daily of placebo supplementation for 8 weeks |
|
| Day 0, Day 56 |
| 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 | 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) | 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 | Day 0, Day 56 |
| D019602 |
| Food and Beverages |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |