The Influence of Probiotics in a Drinkable Yogurt on Skin Health - Full Text View

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Phase 1 The Influence of Probiotics in a Drinkable Yogurt on Skin Health

Resource links provided by NLM:

Drug Information available for: Beta carotene Lactobacillus

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:

Transepidermal water loss [ Time Frame: baseline, 1 month, 2 months, 3 months, 5 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA) [ Time Frame: baseline and at 5 months ] [ Designated as safety issue: No ]


Enrollment:	207
Study Start Date:	February 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	25 Years to 55 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864188

Locations


Germany
Institut für umweltmedizinische Forschung (IUF) an der Heinrich-Heine-Universität Düsseldorf gGmbH
Düsseldorf, Germany, 40225

Sponsors and Collaborators

Nestlé

More Information


Responsible Party:	Nestlé
ClinicalTrials.gov Identifier:	NCT00864188 History of Changes
Other Study ID Numbers:	08.29.NRC
Study First Received:	March 13, 2009
Last Updated:	May 15, 2013
Health Authority:	Germany: Ethics Commission

Keywords provided by Nestlé:


skin health probiotics dairy oral

Additional relevant MeSH terms:


Beta Carotene Carotenoids Vitamins Micronutrients Growth Substances	Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents

ClinicalTrials.gov processed this record on September 26, 2016