ObesityNCT01995110
Postprandial Blood Cell Transcriptome of Normal Weight and Obese Subjects to 3 Caloric Doses of a High-fat Meal
A study testing high-fat meal A, high-fat meal B and high-fat meal C in people with Obesity and Nutritional Intervention, run by Agroscope Liebefeld-Posieux Research Station ALP at 2 sites in Switzerland.
Trial summary
The study will quantitatively evaluate the metabolic response of normal weight and obese subjects to three high-fat meals differing in caloric dose by analysing the postprandial blood transcriptome. 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
- Obesity, Nutritional Intervention
- What is being tested?
- high-fat meal A, high-fat meal B and high-fat meal C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Mar 2011to 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 25-50
- 20<BMI>25
- waist circumference <94cm
- age 25-50
- 30<BMI>40
- waist circumference >102cm
Who cannot join
- physiological or psychological diseases
- allergies to food or intolerance to high-fat meal
- vegetarians, vegans
- chronic intake of drugs
- smokers
- diabetes mellitus type I and II
Show all 10Show fewer
- debiliating kidney disease
- debiliating liver disease
- 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
Bern, Canton of Bern, CH-3003
University Hospital Inselspital Berne
Bern, Canton of Bern, CH-3010
About this study
Official title: Identification of Nutritional Health Biomarkers for Metabolic Flexibility in Blood - a Randomized, Postprandial, Caloric Dose-response Strategy
The study will quantitatively evaluate the metabolic response of normal weight and obese subjects to three high-fat meals differing in caloric dose by analysing the postprandial blood transcriptome.
- Conditions
- Obesity, Nutritional Intervention
- Being tested
- high-fat meal A, high-fat meal B, high-fat meal C
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-fat meal AOther
Also called high-fat meal consisting of 500 kcal
high-fat meal BOther
Also called high-fat meal B consisting of 1000 kcal
high-fat meal COther
Also called high-fat meal C consisting of 1500 kcal
| Study group | Role | What they receive |
|---|---|---|
| normal weight subjects | Experimental | Not described Receives: Other: high-fat meal A; Other: high-fat meal B; Other: high-fat meal C |
| obese subjects | Experimental | Not described Receives: Other: high-fat meal A; Other: high-fat meal B; Other: high-fat meal C |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood cell transkriptome/ gene-expression
- differently expressed genes between normal weight and obese subjects at baseline
- changes in gene-expression 2, 4 and 6h after consumption
Measured: 0h, 2h, 4h, 6h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agroscope Liebefeld-Posieux Research Station ALP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy Vergeres, PhD, Principal investigator, Agroscope Liebefeld-Posieux Research Station ALPDoreen Gille, M.Sc., Study director, Agroscope Liebefeld-Posieux Research Station ALPKurt Laederach, MD, Study director, Inselspital University of Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995110
- Sponsor's protocol ID
- NUTRICHIP-1-transcriptome
- Status last verified
- Apr 2014
- First submitted
- 21 Nov 2013
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Nutritional Health Biomarkers for Metabolic Flexibility in Blood - a Randomized, Postprandial, Caloric Dose-response Strategy
- ClinicalTrials.gov ID
- NCT01995110
- Acronym / sponsor ID
- NUTRICHIP-1-transcriptome
- Conditions
- Obesity, Nutritional Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Agroscope Liebefeld-Posieux Research Station ALPUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Nov 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 metabolic response of normal weight and obese subjects to three high-fat meals differing in caloric dose by analysing the postprandial blood transcriptome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal weight subjects | Experimental | Other: high-fat meal A, Other: high-fat meal B, Other: high-fat meal C |
| obese subjects | Experimental | Other: high-fat meal A, Other: high-fat meal B, Other: high-fat meal C |
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 25-50
- 30<BMI>40
Key exclusion criteria (10 listed)
- physiological or psychological diseases
- allergies to food or intolerance to high-fat meal
- vegetarians, vegans
- 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 meal AAlso: high-fat meal consisting of 500 kcal | Other | normal weight subjects, obese subjects |
| high-fat meal BAlso: high-fat meal B consisting of 1000 kcal | Other | normal weight subjects, obese subjects |
| high-fat meal CAlso: high-fat meal C consisting of 1500 kcal | Other | normal weight subjects, obese subjects |
Primary outcome
blood cell transkriptome/ gene-expression
Time frame: 0h, 2h, 4h, 6h
* differently expressed genes between normal weight and obese subjects at baseline * changes in gene-expression 2, 4 and 6h after consumption
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 24 Apr 2014.
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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.
Guy Vergeres, PhD principal investigator
Agroscope Liebefeld-Posieux Research Station ALP
Doreen Gille, M.Sc. study director
Agroscope Liebefeld-Posieux Research Station ALP
Kurt Laederach, MD study director
Inselspital University of Berne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-fat meal A, high-fat meal B and high-fat meal C in people with Obesity and Nutritional Intervention, run by Agroscope Liebefeld-Posieux Research Station ALP at 2 sites 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 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 24 Apr 2014. 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.
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?
blood cell transkriptome/ gene-expression (time frame: 0h, 2h, 4h, 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 24 Apr 2014.