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.
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
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).
- Conditions
- Inflammation, Dyslipidemia
- 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 group | Role | What they receive |
|---|---|---|
| Probiotic yogurt | Experimental | Daily administration, during two weeks, of two probiotic yogurts (200 mL each) Receives: Dietary Supplement: Probiotic yogurt |
| Acidified milk | Active comparator | Daily 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.
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)
Glucose
Kinetics of glucose during the 6 hours after meal ingestion, in presence of yogurt or placebo
Measured: 6 hours
Insulin
Kinetics of insulin during the 6 hours after meal ingestion, in presence of yogurt or placebo
Measured: 6 hours
Glucagon like polypeptide-1
Kinetics of GLP-1 during the 6 hours after meal ingestion, in presence of yogurt or placebo
Measured: 6 hours
Gastric inhibitory polypeptide
Kinetics of GIP during the 6 hours after meal ingestion, in presence of yogurt or placebo
Measured: 6 hours
Total cholesterol
Kinetics of total cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
Measured: 6 hours
LDL-cholesterol
Kinetics of LDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
Measured: 6 hours
HDL-cholesterol
Kinetics of HDL-cholesterol during the 6 hours after meal ingestion, in presence of yogurt or placebo
Measured: 6 hours
Non esterified fatty acids
Kinetics of NEFAs during the 6 hours after meal ingestion, in presence of yogurt or placebo
Measured: 6 hours
Triglycerides
Kinetics of triglycerides during the 6 hours after meal ingestion, in presence of yogurt or placebo
Measured: 6 hours
Interleukin-6
Kinetics of IL-6 will be measured in blood of volunteers after the administration of yogurt or placebo
Measured: 6 hours
Chemokine CCK2
Kinetics of CCK2 will be measured in blood of volunteers after the administration of yogurt or placebo
Measured: 6 hours
Chemokine CCK5
Kinetics of CCK5 will be measured in blood of volunteers after the administration of yogurt or placebo
Measured: 6 hours
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
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.
- First posted3 Sep 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Agroscope Liebefeld-Posieux Research Station ALP
- Responsible party
- Principal investigator, Francois Pralong, Centre Hospitalier Universitaire Vaudois
- Investigators
- Francois P Pralong, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
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 30721917Pimentel 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of a Probiotic Yoghourt on the Metabolic Health of Normal Male Volunteers
- ClinicalTrials.gov ID
- NCT02230345
- Acronym / sponsor ID
- FFF / 392/13
- Conditions
- Inflammation, Dyslipidemia
- Keywords
- Probiotic, Yoghourt, Inflammation, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Agroscope Liebefeld-Posieux Research Station ALP
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic yogurt | Experimental | Dietary Supplement: Probiotic yogurtDaily administration, during two weeks, of two probiotic yogurts (200 mL each) |
| Acidified milk | Active comparator | Dietary Supplement: Acidified milkDaily administration, over two consecutive weeks, of an isocaloric dose (compared to probiotics) of unfermented acidified milk |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal male with normal BMI (18.5-25 kg/m2)
- non smoker
- stable physical activity
Key exclusion criteria (7 listed)
- Food intolerance (ceoliac disease, lactose intolerance, food allergies)
- Particular regimen (vegetarian...)
- Chronic disease (any)
- Elevated blood pressure
- Regular drug treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic yogurtAlso: LGGProbiotic 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). | Dietary supplement | Probiotic yogurt |
| Acidified milkAlso: MilkMilk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk | Dietary supplement | Acidified milk |
Primary outcome
Metabolomic analyses
Time frame: 6 hours
Kinetics of metabolomic changes in blood during the 6 hours after meal ingestion, in presence of yogurt or placebo
14 secondary outcomes
Glucose
Time frame: 6 hours
Insulin
Time frame: 6 hours
Glucagon like polypeptide-1
Time frame: 6 hours
Gastric inhibitory polypeptide
Time frame: 6 hours
Total cholesterol
Time frame: 6 hours
LDL-cholesterol
Time frame: 6 hours
HDL-cholesterol
Time frame: 6 hours
Non esterified fatty acids
Time frame: 6 hours
Triglycerides
Time frame: 6 hours
Interleukin-6
Time frame: 6 hours
Chemokine CCK2
Time frame: 6 hours
Chemokine CCK5
Time frame: 6 hours
Tunour necrosis factor alpha
Time frame: 6 hours
Lipo-poly-saccharide
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Derived from this study: PubMed 30721917Vionnet 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.
- Derived from this study: PubMed 29788433Pimentel 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.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois P Pralong, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
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.