The Influence of Probiotics in a Drinkable Yogurt on Skin Health

Sponsor

Nestlé (Industry)

Overall Status

Completed

CT.gov ID

NCT00864188

Collaborator

(none)

207

Enrollment

Location

Arms

13.9

Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Skin Health	Dietary Supplement: no bacterial strains Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461 Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus Dietary Supplement: Vit B2, B3, C and E, Beta Carotene and Oil	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

207 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Glucono-Delta-Lactone acidified milk containing no bacterial strains	Dietary Supplement: no bacterial strains Glucono-Delta-Lactone acidified milk containing no bacterial strains
Experimental: 2 Glucono-Delta-Lactone acidified milk containing one probiotic strain called Lactobacillus paracasei NCC2461.	Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461 Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.
Placebo Comparator: 3 Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii subsp.bulgaricus.	Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus Fermented milk containing two standard yogurt bacterial strains.
Experimental: 4 Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii and one probiotic strain called Lactobacillus paracasei NCC2461.	Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461 Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain. Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus Fermented milk containing two standard yogurt bacterial strains.
Experimental: 5 Fermented milk containing two standard bacterial strains for acidification - Streptococcus thermophilus and Lactobacillus delbrueckii, one probiotic strain called Lactobacillus paracasei NCC2461 and Vitamin B2,B3, C and E, Beta Carotene and an Oil.	Dietary Supplement: One probiotic strain - Lactobacillus paracasei NCC2461 Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain. Dietary Supplement: Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus Fermented milk containing two standard yogurt bacterial strains. Dietary Supplement: Vit B2, B3, C and E, Beta Carotene and Oil Fermented milk containing nutritional supplements

Outcome Measures

Primary Outcome Measures

Transepidermal water loss [baseline, 1 month, 2 months, 3 months, 5 months and 6 months]

Secondary Outcome Measures

Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA) [baseline and at 5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.