Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

NCT05597254 | Completed

• 1 other identifier: 2022-00672-01
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Skin Manifestations

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (1)

• Questionnaire on general health and wellbeing

  Day 0, Day 28, Day 56

Study Arms (3)

Probiotic with niacin and berry extract

EXPERIMENTAL

Dietary Supplement: Probiotic with niacin and berry extract

Probiotic without niacin and berry extract

ACTIVE COMPARATOR

Dietary Supplement: Probiotic without niacin and berry extract

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic with niacin and berry extract DIETARY_SUPPLEMENT

1 capsule daily of probiotic with niacin supplementation for 8 weeks

Probiotic with niacin and berry extract

Probiotic without niacin and berry extract DIETARY_SUPPLEMENT

1 capsule daily of probiotic without niacin supplementation for 8 weeks

Probiotic without niacin and berry extract

Placebo DIETARY_SUPPLEMENT

1 capsule daily of placebo supplementation for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oriflame Cosmetics AB: lead

Study Sites (1)

Oriflame Cosmetics

Stockholm, 11226, Sweden

Location

MeSH Terms

Conditions

Skin Manifestations

Interventions

Probiotics; Niacin; Fruit

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Isabella Lee

  Global Senior Nutritional Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 28, 2022
• Study Start: September 26, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

SE (1)