The Influence of Probiotics in a Drinkable Yogurt on Skin Health

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00864188
First received: March 13, 2009
Last updated: May 15, 2013
Last verified: September 2009
  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:


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
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

No publications provided

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

ClinicalTrials.gov processed this record on August 01, 2014