ObeseNCT01726647
Metabolism Associated With Abdominal Fat Mass Distribution
An observational study of Obese, run by Société des Produits Nestlé (SPN) at 2 sites in Switzerland.
Trial summary
Objectives: The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat). No intervention with a product is planned. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obese
- How many people
- 40 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Sep 2008to Apr 2012
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Obese women
Who may be able to join
- BMI 29-40 kg/m2
- Aged 25-45
Who cannot join
- Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease, metabolic syndrome
- Pregnancy
- Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study.
- Any therapy (contraception apart) within the run-in period of one week before the test day.
- Subject who cannot be expected to comply with treatments and measures.
- Subject who is affected by any specific eating disorder
- Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- Subjects having recently undergone a weight loss of more than 3 kilos during the last 3 months
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Nestlé Clinical Development Unit / Metabolic Unit
Lausanne, 1000
University Hospitals, Service of endocrinology, diabetology, and metabolism
Lausanne, 1011
About this study
Objectives:
The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat).
No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.
- Conditions
- Obese
- Keywords
- obese women, fat mass distribution, Metabolomic profiles
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No product is tested | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic plasma, urine and faeces profiles as a function of fat mass distribution
Metabolic profiles of plasma, urine and feces samples are obtained by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry.
Fat mass distribution is assessed using CT scan and DXA (Dual X-Ray Energy Absorptiometry).
Measured: Changes from baseline in metabolic profiles at one day following fat meal intake
Secondary outcomes (2)
Insulin sensitivity
Insulin sensitivity is measured by oral glucose tolerance test
Measured: Measured on the day before the fat meal intake
Basal Energy Expenditure
Basal Energy Expenditure is measured by indirect calorimetry
Measured: Basal Energy Expenditure is measured on the day preceding the fat meal intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startSep 2008
- Primary completionOct 2009
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Observational
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Vittorio Giusti, MD, PD/MER, Principal investigator, University Hospitals of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726647
- Sponsor's protocol ID
- 08.02.NRC
- Status last verified
- Nov 2012
- First submitted
- 6 Nov 2012
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism Associated With Abdominal Fat Mass Distribution
- ClinicalTrials.gov ID
- NCT01726647
- Acronym / sponsor ID
- 08.02.NRC
- Conditions
- Obese
- Keywords
- obese women, fat mass distribution, Metabolomic profiles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- University of Lausanne Hospitals
- Study start
- Sep 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Nov 2012 (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.
Objectives:
The primary objective of this clinical trial is to characterize metabolic signatures associated with abdominal fat distribution in 40 women with different BMI 29-40 and different abdominal distribution of fat (visceral vs. sub-cutaneous fat).
No intervention with a product is planned. The subjects will be given one high fat meal with commercial products (eggs, milk, cream, bread, fruits, cheese and cheese) on one test day to test the post-prandial metabolic response.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No product is tested | – | –No intervention |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Obese women
Key inclusion criteria (2 listed)
- BMI 29-40 kg/m2
- Aged 25-45
Key exclusion criteria (8 listed)
- Diagnosed metabolic disorder such as Diabetes type 1 and 2, cardiovascular disease, metabolic syndrome
- Pregnancy
- Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study.
- Any therapy (contraception apart) within the run-in period of one week before the test day.
- Subject who cannot be expected to comply with treatments and measures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic plasma, urine and faeces profiles as a function of fat mass distribution
Time frame: Changes from baseline in metabolic profiles at one day following fat meal intake
Metabolic profiles of plasma, urine and feces samples are obtained by Nuclear Magnetic Resonance spectroscopy and Mass Spectrometry. Fat mass distribution is assessed using CT scan and DXA (Dual X-Ray Energy Absorptiometry).
2 secondary outcomes
Insulin sensitivity
Time frame: Measured on the day before the fat meal intake
Basal Energy Expenditure
Time frame: Basal Energy Expenditure is measured on the day preceding the fat meal intake
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 15 Nov 2012.
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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.
Vittorio Giusti, MD, PD/MER principal investigator
University Hospitals of Lausanne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obese, run by Société des Produits Nestlé (SPN) 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 2 inclusion and 8 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 15 Nov 2012. 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?
Metabolic plasma, urine and faeces profiles as a function of fat mass distribution (time frame: Changes from baseline in metabolic profiles at one day following fat meal intake). 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 15 Nov 2012.