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InflammationFFFNCT02230345

Effects of a Probiotics on the Health of Normal Young Males

A study testing Probiotic yogurt and Acidified milk in people with Inflammation and Dyslipidemia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The important role played by the GI tract microflora on the metabolic health of an individual are increasingly recognized. In this respect, the initial studies of Metchinkoff that suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora have evolved into the concept of "probiotics". Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Inflammation, Dyslipidemia
What is being tested?
Probiotic yogurt and Acidified milk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteSwitzerland
Study dates
Mar 2014to Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Normal male with normal BMI (18.5-25 kg/m2)
  • non smoker
  • stable physical activity

Who cannot join

  • Food intolerance (ceoliac disease, lactose intolerance, food allergies)
  • Particular regimen (vegetarian...)
  • Chronic disease (any)
  • Elevated blood pressure
  • Regular drug treatment
  • Antibiotics treatement in the preceding six months
  • >4 hrs/week of physical activity

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Clinical research center, Lausanne University hospital

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: Study of the Effects of a Probiotic Yoghourt on the Metabolic Health of Normal Male Volunteers

The important role played by the GI tract microflora on the metabolic health of an individual are increasingly recognized. In this respect, the initial studies of Metchinkoff that suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora have evolved into the concept of "probiotics". Probiotics are living microorganisms that bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001).

Here the investigators will study, in normal young male volunteers, the potential to modulate post-prandial metabolic and inflammatory responses by the administration of a yoghourt containing the probiotic Lactobacillus rhamnosus (LGG).

Read the detailed description

This is a prospective, randomized, double-blind and cross-over study designed to evaluate the potential of a probiotic (Lactobacillus rhamnosus) to modulate the post prandial metabolic and inflammatory response of normale healthy individuals.

After a wash out period during which volunteers will have to follow a diet devoid of all milk or milk-derived products, they will receive, in random order, either a daily dose of the probiotic, or a daily dose of acidified milk (control) for a total of three consecutive weeks. At the end of each of these period, they will be submitted to a day of investigation, during which their metabolic and inflammatory profile will be studied following the ingestion of a standard test meal. The potential for the probiotic to modulate the metabolic and inflammatory parameters will be evaluated.

The test meal will provide 1004Kcal under the form of 45.4g proteins (17%), 69g total fatty acids (62%), and 52.6g glucids (21%) as previously published (Schwander et al, J Nut 2014).

Being tested
Probiotic yogurt, Acidified milk
Keywords
Probiotic, Yoghourt, Inflammation, Metabolomics
Medical subject headings
Inflammation, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic yogurtDietary supplement

    Also called LGG

    Probiotic yogurt (fermented milk with Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus- YoFlex FD-DVS YC-X11 Fr, with the addition of Lactobacillus rhamnosus GG (LGG)- Culture Collection, University of Göteborg, Sweden CCUG 34291).

  • Acidified milkDietary supplement

    Also called Milk

    Milk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk

Study groups in NCT02230345
Study groupRoleWhat they receive
Probiotic yogurtExperimentalDaily administration, during two weeks, of two probiotic yogurts (200 mL each)
Receives: Dietary Supplement: Probiotic yogurt
Acidified milkActive comparatorDaily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk
Receives: Dietary Supplement: Acidified milk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolomic analyses

    Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

Secondary outcomes (14)

  1. Glucose

    Kinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

  2. Insulin

    Kinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

  3. Glucagon like polypeptide-1

    Kinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

  4. Gastric inhibitory polypeptide

    Kinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

  5. Total cholesterol

    Kinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

  6. LDL-cholesterol

    Kinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

  7. HDL-cholesterol

    Kinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

  8. Non esterified fatty acids

    Kinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

  9. Triglycerides

    Kinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo

    Measured: 6 hours

  10. Interleukin-6

    Kinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo

    Measured: 6 hours

  11. Chemokine CCK2

    Kinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo

    Measured: 6 hours

  12. Chemokine CCK5

    Kinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo

    Measured: 6 hours

  13. Tunour necrosis factor alpha

    Kinetics of TNF-a will be measured in blood of volunteers after the administration of yogurt or placebo

    Measured: 6 hours

  14. Lipo-poly-saccharide

    Kinetics of LPS will be measured in blood of volunteers after the administration of yogurt or placebo

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2014
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02230345
Sponsor's protocol ID
392/13
Acronym
FFF
Status last verified
Aug 2015
First submitted
21 Jul 2014
Last updated
21 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Vionnet N, Munger LH, Freiburghaus C, Burton KJ, Pimentel G, Pralong FP, Badertscher R, Vergeres G. Assessment of lactase activity in humans by measurement of galactitol and galactonate in serum and urine after milk intake. Am J Clin Nutr. 2019 Feb 1;109(2):470-477. doi: 10.1093/ajcn/nqy296.

    PubMed 30721917

  • Pimentel G, Burton KJ, von Ah U, Butikofer U, Pralong FP, Vionnet N, Portmann R, Vergeres G. Metabolic Footprinting of Fermented Milk Consumption in Serum of Healthy Men. J Nutr. 2018 Jun 1;148(6):851-860. doi: 10.1093/jn/nxy053.

    PubMed 29788433

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic yogurt and Acidified milk in people with Inflammation and Dyslipidemia, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metabolomic analyses (time frame: 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02230345, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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