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Completed

NCT Number: NCT00864188

The Influence of Probiotics in a Drinkable Yogurt on Skin Health

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

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Key information

Conditions

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

Düsseldorf, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

no bacterial strains

Dietary Supplement

Glucono-Delta-Lactone acidified milk containing no bacterial strains

One probiotic strain - Lactobacillus paracasei NCC2461

Dietary Supplement

Glucono-Delta-Lactone acidified or fermented milk containing one probiotic strain.

Two standard yogurt fermenting bacterial strains - Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus

Dietary Supplement

Fermented milk containing two standard yogurt bacterial strains.

Vit B2, B3, C and E, Beta Carotene and Oil

Dietary Supplement

Fermented milk containing nutritional supplements

Primary outcomes

  1. Transepidermal water loss

    Time frame: baseline, 1 month, 2 months, 3 months, 5 months and 6 months

Secondary outcomes

  1. Biopsy markers: transglutaminase, filagrin, involucrin, loricrin (mRNA)

    Time frame: baseline and at 5 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 18, 2009
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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