Nutritional InterventionEarly Phase 1NCT01446068

Comparison of Postprandial Inflammation in Lean and Obese Subjects

A Early Phase 1 study testing High-fat meal in people with Nutritional Intervention and Nutritional and Metabolic Diseases, run by Agroscope Liebefeld-Posieux Research Station ALP at 2 sites 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 purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal. Read more about this study

Who is it for?: Ages 25 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Nutritional Intervention, Nutritional and Metabolic Diseases, Obesity
What is being tested?: High-fat meal
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 2 sitesSwitzerland
Study dates: Mar 2011to Jan 2013
Phase: Early Phase 1
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

age 25-50
20<BMI<25
waist circumference <94cm
age-matched to healthy subjects
30<BMI<40
waist circumference >102cm

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

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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

2 sites in 1 country.

Switzerland2 sites

Agroscope Liebefeld-Posieux ALP Research Station
Bern, Canton of Bern, 3003
University Hospital Inselspital, Berne
Bern, Canton of Bern, 3010

Other trials in Switzerland

About this study

The purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.

Conditions: Nutritional Intervention, Nutritional and Metabolic Diseases, Obesity
Being tested: High-fat meal
Medical subject headings: Nutritional and Metabolic Diseases, Obesity

What participants receive

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

High-fat mealDietary supplement
Three caloric doses of high-fat meal (500, 1000, 1500 kcal)

Study groups in NCT01446068
Study group	Role	What they receive
Lean Subjects	Experimental	Not described Receives: Dietary Supplement: High-fat meal
Obese subjects	Experimental	Not described Receives: Dietary Supplement: High-fat meal

What is being measured

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

Interleukin-6 (serum)
A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h
Measured: 4h vs 0h

Secondary outcomes (10)

Glucose (serum)
Measured: 0h, 1h, 2h, 4h, 6h
Triglyceride (serum)
Measured: 0h, 1h, 2h, 4h, 6h
Insulin (serum)
Measured: 0h, 1h, 2h, 4h, 6h
high sensitivity C-Reactive Protein
Measured: 0h, 1h, 2h, 4h, 6h
HDL-cholesterol
Measured: 0h, 1h, 2h, 4h, 6h
Total cholesterol
Measured: 0h, 1h, 2h, 4h, 6h
Total cholesterol / HDL cholesterol
Measured: 0h, 1h, 2h, 4h, 6h
Interleukin-6 (serum)
Measured: 0h, 1h, 2h, 4h, 6h
Glucagon-like-protein-1 (serum)
Measured: 0h, 1h 2h, 4h, 6h
Endotoxin (serum)
Measured: 0h, 1h, 2h, 4h, 6h

Timeline

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

Mar 2011Jan 2013

First posted4 Oct 2011 (estimated)
Study startMar 2011
Primary completionJun 2012
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nutritional InterventionStudies 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: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01446068
Sponsor's protocol ID: NUTRICHIP-1
Status last verified: Jun 2013
First submitted: 29 Sep 2011
Last updated: 20 Jun 2013
Results posted: No
Data monitoring committee: Yes

Publications

Schwander F, Kopf-Bolanz KA, Buri C, Portmann R, Egger L, Chollet M, McTernan PG, Piya MK, Gijs MA, Vionnet N, Pralong F, Laederach K, Vergeres G. A dose-response strategy reveals differences between normal-weight and obese men in their metabolic and inflammatory responses to a high-fat meal. J Nutr. 2014 Oct;144(10):1517-23. doi: 10.3945/jn.114.193565. Epub 2014 May 8.
PubMed 24812072

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Postprandial Inflammation in Lean and Obese Subjects
ClinicalTrials.gov ID: NCT01446068
Acronym / sponsor ID: NUTRICHIP-1
Conditions: Nutritional Intervention, Nutritional and Metabolic Diseases, Obesity
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Agroscope Liebefeld-Posieux Research Station ALPUniversity, hospital or other
Collaborators: Insel Gruppe AG, University Hospital Bern
Study start: Mar 2011
Primary completion: Jun 2012 (actual)
Study completion: Jan 2013 (actual)
First posted: 4 Oct 2011 (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 purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lean Subjects	Experimental	Dietary Supplement: High-fat meal
Obese subjects	Experimental	Dietary Supplement: High-fat meal

Who may qualify

Ages: 25 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

age 25-50
20<BMI<25
waist circumference <94cm
age-matched to healthy subjects
30<BMI<40

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
High-fat mealThree caloric doses of high-fat meal (500, 1000, 1500 kcal)	Dietary supplement	Lean Subjects, Obese subjects

Primary outcome

Interleukin-6 (serum)
Time frame: 4h vs 0h
A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h

10 secondary outcomes

Glucose (serum)
Time frame: 0h, 1h, 2h, 4h, 6h
Triglyceride (serum)
Time frame: 0h, 1h, 2h, 4h, 6h
Insulin (serum)
Time frame: 0h, 1h, 2h, 4h, 6h
high sensitivity C-Reactive Protein
Time frame: 0h, 1h, 2h, 4h, 6h
HDL-cholesterol
Time frame: 0h, 1h, 2h, 4h, 6h
Total cholesterol
Time frame: 0h, 1h, 2h, 4h, 6h
Total cholesterol / HDL cholesterol
Time frame: 0h, 1h, 2h, 4h, 6h
Interleukin-6 (serum)
Time frame: 0h, 1h, 2h, 4h, 6h
Glucagon-like-protein-1 (serum)
Time frame: 0h, 1h 2h, 4h, 6h
Endotoxin (serum)
Time frame: 0h, 1h, 2h, 4h, 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 20 Jun 2013.
Derived from this study: PubMed 24812072Schwander F, Kopf-Bolanz KA, Buri C, Portmann R, Egger L, Chollet M, McTernan PG, Piya MK, Gijs MA, Vionnet N, Pralong F, Laederach K, Vergeres G. A dose-response strategy reveals differences between normal-weight and obese men in their metabolic and inflammatory responses to a high-fat meal. J Nutr. 2014 Oct;144(10):1517-23. doi: 10.3945/jn.114.193565. Epub 2014 May 8.

Related trials for Nutritional Intervention

Not yet recruiting
Nutrition Intervention Optimization to Better Utilize Resources and Support Health
Diabete Type 2, Obesity & Overweight
Recruiting
The Effect of Olive Leaf Extract Supplementation on Training-induced Skeletal Muscle Functional and Molecular Adaptations in Healthy Volunteers
Healthy Adult Participants, Exercise Training
Active, not recruiting
Early Nutritional Intervention in Patients With Cancer
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Active, not recruiting
Effect of the Consumption of Cookies Enriched With Plant Proteins and of a Vitamin D Supplement on the Progression of Sarcopenia in the Elderly
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Recruiting
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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.

Kurt Laederach, MD study director

Inselspital University of Berne

Katrin Bolanz, PhD principal investigator

Agroscope Liebefeld-Posieux ALP Research Station

Flurina Schwander, M.Sc. principal investigator

Agroscope Liebefeld-Posieux ALP Research Station

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Interleukin-6 (serum) (time frame: 4h vs 0h). 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 NCT01446068, which also lists 1 linked publication.

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 20 Jun 2013; AzTrials last refreshed its copy on 7 Nov 2026.