The Influence of Probiotics in a Drinkable Yogurt on Skin Health

Skin Health Clinical Trial

Official title:

Phase 1 The Influence of Probiotics in a Drinkable Yogurt on Skin Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864188
• Other study ID #: 08.29.NRC
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2009
• Last updated: May 15, 2013
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: September 2009
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test if probiotics administered to healthy female subjects in a dairy format have any skin health benefits.

Description:

This is a placebo-controlled, double blind, randomized, single center, human clinical trial aimed at assessing the influence of probiotics on skin health in healthy female subjects, when administered in a food matrix over a period of 5 months.

It will consist of five groups(40 subjects/group). The first group (1) of subjects will receive acidified milk that does not contain bacterial strains. The second group (2) will receive acidified milk that contains one specific probiotic strain. The third group (3) will receive fermented milk that contains a standard mix of yogurt bacterial strains. The fourth group (4) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 plus the same specific probiotic strain as in group 2. Finally, the fifth group (5) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 and 4 plus the same specific probiotic strain as in group 2 and 4 plus a mix of antioxidants.

This study will address whether:

A.The bioefficacy of a specific probiotic strain is influenced by a milk matrix.

B.Whether other bacterial strains impact the bioefficacy of this specific probiotic strain, and validate whether or not the bioefficacy is related entirely to the activity of this specific probiotic strain.

C.Whether nutritional supplements impact the bioefficacy of a specific probiotic strain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy women as assessed by medical history and standard medical examination

• Caucasian

• Age: 25-55 y (inclusive)

• Normal BMI = 30

• Skin type 1-111

• Regular Hormonal Cycle

• Having given his/her written informed consent

• Willing to avoid the consumption of fermented dairy products

• Minimum consumption of dark chocolate during the period of the study

Exclusion Criteria:

• Smoker

• Pregnant or lactating women

• Post menopausal women

• Heavy alcohol intake (usually consuming more than 3 standard drinks/day)

• Intake of chronic medications except oral contraceptive

• Vitamin and/or mineral and/or antioxidant supplementation over the 3 months preceding the initiation of the study and throughout the study.

• Having skin cancer or genetic disposition to skin cancer

• Regular exposure to artificial UVR

• Daily exposure to sun more than one week over the 2 months preceding the initiation of the study

• Planned vacation to sun during the period of the study.

• Excessive tea drinkers (more than 2 cups a day of green or black tea).

• Excessive consumer of fermented dairy products (more than 150g per day).

• Excessive consumer of dark chocolate (> 25g per day).

• Regular high exercise such as a marathon

• Subject who regularly takes saunas (dry or wet) or swims daily.

• Subject who cannot be expected to comply with treatment

• Currently participating or having participated in another interventional clinical trial during the last 3 months prior to the beginning of this study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Skin Health

Intervention

Dietary Supplement:
• no bacterial strains
Glucono-Delta-Lactone acidified milk containing no bacterial strains
• One probiotic strain - Lactobacillus paracasei NCC2461
Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.
• Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus
Fermented milk containing two standard yogurt bacterial strains.
• Vit B2, B3, C and E, Beta Carotene and Oil
Fermented milk containing nutritional supplements

Locations

Country	Name	City	State
Germany	Institut für umweltmedizinische Forschung (IUF) an der Heinrich-Heine-Universität Düsseldorf gGmbH	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transepidermal water loss		baseline, 1 month, 2 months, 3 months, 5 months and 6 months	No
Secondary	Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA)		baseline and at 5 months	No