Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

NCT ID: NCT05597254

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2022-12-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic with niacin and berry extract

Group Type: EXPERIMENTAL

Probiotic with niacin and berry extract

Intervention Type: DIETARY_SUPPLEMENT

1 capsule daily of probiotic with niacin supplementation for 8 weeks

Probiotic without niacin and berry extract

Group Type: ACTIVE_COMPARATOR

Probiotic without niacin and berry extract

Intervention Type: DIETARY_SUPPLEMENT

1 capsule daily of probiotic without niacin supplementation for 8 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

1 capsule daily of placebo supplementation for 8 weeks

Interventions

Probiotic with niacin and berry extract

1 capsule daily of probiotic with niacin supplementation for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Probiotic without niacin and berry extract

1 capsule daily of probiotic without niacin supplementation for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

1 capsule daily of placebo supplementation for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oriflame Cosmetics AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabella Lee

Role: PRINCIPAL_INVESTIGATOR

Global Senior Nutritional Scientist

Locations

Oriflame Cosmetics

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2022-00672-01

Identifier Type: -

Identifier Source: org_study_id