InflammationNCT01885416
Impact of Dairy Products on Postprandial Inflammation
A study testing consumption of test meal based on dairy products, consumption of high fat test meal without dairy products and consumption of high fat test meal with dairy products in people with Inflammation and Obesity, run by Agroscope Liebefeld-Posieux Research Station ALP at 1 site in Switzerland.
Trial summary
The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic response to the ingestion of three different meals in obese subjects. The administered meals will differ in the proportion of dairy products. Postprandial response will be monitored during 6 hours after meal consumption. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Obesity, Nutritional Intervention
- What is being tested?
- consumption of test meal based on dairy products, consumption of high fat test meal without dairy products and consumption of high fat test meal with dairy products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to Nov 2013
- 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 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- BMI ≥ 20 kg/m2
- age 25-55 y
- informed consent
Who cannot join
- Physiological or psychological diseases
- Allergies to food or intolerance to high-fat meal
- Vegetarians
- Chronic intake of drugs
- Smokers
- Diabetes mellitus Type I and II
Show all 10Show fewer
- Debilitating kidney diseases
- Debilitating liver diseases
- Clinically established coronary heart diseases
- Ingestion of vitamins or dietary supplements during the course of the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital, Inselspital Berne
Bern, Canton of Bern, 3010
About this study
Official title: The Impact of Dairy Products on Postprandial Inflammation in Obese Males
The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic response to the ingestion of three different meals in obese subjects. The administered meals will differ in the proportion of dairy products. Postprandial response will be monitored during 6 hours after meal consumption.
- Conditions
- Inflammation, Obesity, Nutritional Intervention
- Being tested
- consumption of test meal based on dairy products, consumption of high fat test meal without dairy products, consumption of high fat test meal with dairy products
- Medical subject headings
- Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consumption of test meal based on dairy productsOther
consumption of high fat test meal without dairy productsOther
consumption of high fat test meal with dairy productsOther
| Study group | Role | What they receive |
|---|---|---|
| high fat meal without dairy products | Active comparator | high fat meal without dairy products Receives: Other: consumption of high fat test meal without dairy products |
| high fat meal with additional milk | Experimental | high fat meal with additional milk Receives: Other: consumption of high fat test meal with dairy products |
| dairy product meal | Experimental | dairy product meal Receives: Other: consumption of test meal based on dairy products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation markers in blood plasma (IL-6, TNF-alpha)
Measured: 0,6h
Secondary outcomes (2)
Biomarkers in blood (serum insulin, plasma glucose, GLP-1, lipids)
Measured: 0,1,2,4,6h
Endotoxin in blood serum
Measured: 0,6h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agroscope Liebefeld-Posieux Research Station ALP
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Principal investigator, Guy Vergeres, Agroscope Liebefeld-Posieux Research Station ALP
- Investigators
- Kur Laederach, MD, Principal investigator, Insel Gruppe AG, University Hospital BernAlexandra Schmid, Study director, Agroscope Liebefeld-Posieux ALPCaroline Buri, MD, PhD, Study director, Insel Gruppe AG, University Hospital BernGuy Vergères, PhD, Study director, Agroscope Liebefeld-Posieux ALP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885416
- Sponsor's protocol ID
- NUTRICHIP-2
- Status last verified
- Nov 2013
- First submitted
- 19 Jun 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dairy Products on Postprandial Inflammation in Obese Males
- ClinicalTrials.gov ID
- NCT01885416
- Acronym / sponsor ID
- NUTRICHIP-2
- Conditions
- Inflammation, Obesity, Nutritional Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Agroscope Liebefeld-Posieux Research Station ALPUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Jun 2013 (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 study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic response to the ingestion of three different meals in obese subjects. The administered meals will differ in the proportion of dairy products. Postprandial response will be monitored during 6 hours after meal consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high fat meal without dairy products | Active comparator | Other: consumption of high fat test meal without dairy productshigh fat meal without dairy products |
| high fat meal with additional milk | Experimental | Other: consumption of high fat test meal with dairy productshigh fat meal with additional milk |
| dairy product meal | Experimental | Other: consumption of test meal based on dairy productsdairy product meal |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male
- BMI ≥ 20 kg/m2
- age 25-55 y
- informed consent
Key exclusion criteria (10 listed)
- Physiological or psychological diseases
- Allergies to food or intolerance to high-fat meal
- Vegetarians
- Chronic intake of drugs
- Smokers
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 |
|---|---|---|
| consumption of test meal based on dairy products | Other | dairy product meal |
| consumption of high fat test meal without dairy products | Other | high fat meal without dairy products |
| consumption of high fat test meal with dairy products | Other | high fat meal with additional milk |
Primary outcome
Inflammation markers in blood plasma (IL-6, TNF-alpha)
Time frame: 0,6h
2 secondary outcomes
Biomarkers in blood (serum insulin, plasma glucose, GLP-1, lipids)
Time frame: 0,1,2,4,6h
Endotoxin in blood serum
Time frame: 0,6h
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 19 Nov 2013.
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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.
Kur Laederach, MD principal investigator
Insel Gruppe AG, University Hospital Bern
Alexandra Schmid study director
Agroscope Liebefeld-Posieux ALP
Caroline Buri, MD, PhD study director
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing consumption of test meal based on dairy products, consumption of high fat test meal without dairy products and consumption of high fat test meal with dairy products in people with Inflammation and Obesity, run by Agroscope Liebefeld-Posieux Research Station ALP 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 4 inclusion and 10 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 19 Nov 2013. 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?
Inflammation markers in blood plasma (IL-6, TNF-alpha) (time frame: 0,6h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2013.