ObesitySURNUTNCT00905892
Metabolic Fate Modifications of Saturated Fats After an Overfeeding
A study testing Hyperlipidic overfeeding in people with Obesity and Lipid Metabolism, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe at 1 site in France.
Trial summary
The purpose of this study is to determine the partitioning of exogenous lipids in the postprandial period while a study of overfeeding. The method is based on the incorporation of a stable isotopic tracer (d31_palmitic acid, d31_C16) in lipoprotein triglycerides (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Lipid Metabolism, Inflammation
- What is being tested?
- Hyperlipidic overfeeding
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Mar 2010
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 55 years old
- BMI 18 to 30 kg/m²
- Stable physical activity
- Safety subject during medical consultation
Who cannot join
- Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflammatory diseases)
- Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones)
- Eating disorder
- Intensive sportive activity
- Subjects who Smoke
- Claustrophobic subjects
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de recherche en nutrition humaine Rhone-Alpes
Pierre-Bénite, 69495
About this study
The purpose of this study is to determine the partitioning of exogenous lipids in the postprandial period while a study of overfeeding. The method is based on the incorporation of a stable isotopic tracer (d31_palmitic acid, d31_C16) in lipoprotein triglycerides (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids (FFA).
Read the detailed description
Healthy overweight and lean young men are subjected to an overfeeding during 56 days which corresponds to a supplement of 761 Kcal/day. During two exploration days (before : D0 et after : D56 overfeeding) they have ingested a breakfast with tracer (d31_palmitic acid, d31_C16, 20mg/kg) and blood and urine samples were collected every hour of each exploration day. The enrichment in deuterium was measured by gas chromatography-organic mass spectrometry (GC-OMS) in palmitic acid pool of lipid fractions.
- Conditions
- Obesity, Lipid Metabolism, Inflammation
- Being tested
- Hyperlipidic overfeeding
- Keywords
- overfeeding, stable isotopes, lipoprotein metabolism, lipid oxidation, fat distribution, gene expression, endotoxemia, mass spectrometry/gas chromatography
- Medical subject headings
- Obesity, Inflammation, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperlipidic overfeedingDietary supplement
100g per day of cheese + 40g per day of almonds + 20g per day of butter
What is being measured
The primary outcome is the main question the study is designed to answer.
Post prandial partitioning of exogenous lipids
Measured: Before and after overfeeding
Secondary outcomes (1)
Genes expression in adipose and muscle tissues
Measured: Before and after overfeeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Sponsor type
- University, hospital or other
- Investigators
- Martine Laville, PhD, MD, Study director, Centre de Recherche en Nutrition Humaine Rhone-Alpe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905892
- Sponsor's protocol ID
- CRNHRA-09-002
- Acronym
- SURNUT
- Status last verified
- Jun 2011
- First submitted
- 20 May 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Segrestin B, Moreno-Navarrete JM, Seyssel K, Alligier M, Meugnier E, Nazare JA, Vidal H, Fernandez-Real JM, Laville M. Adipose Tissue Expansion by Overfeeding Healthy Men Alters Iron Gene Expression. J Clin Endocrinol Metab. 2019 Mar 1;104(3):688-696. doi: 10.1210/jc.2018-01169.
PubMed 30260393Seyssel K, Alligier M, Meugnier E, Chanseaume E, Loizon E, Canto C, Disse E, Lambert-Porcheron S, Brozek J, Blond E, Rieusset J, Morio B, Laville M, Vidal H. Regulation of energy metabolism and mitochondrial function in skeletal muscle during lipid overfeeding in healthy men. J Clin Endocrinol Metab. 2014 Jul;99(7):E1254-62. doi: 10.1210/jc.2013-4379. Epub 2014 Mar 31.
PubMed 24684464Alligier M, Meugnier E, Debard C, Lambert-Porcheron S, Chanseaume E, Sothier M, Loizon E, Hssain AA, Brozek J, Scoazec JY, Morio B, Vidal H, Laville M. Subcutaneous adipose tissue remodeling during the initial phase of weight gain induced by overfeeding in humans. J Clin Endocrinol Metab. 2012 Feb;97(2):E183-92. doi: 10.1210/jc.2011-2314. Epub 2011 Dec 7.
PubMed 22162470
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Fate Modifications of Saturated Fats After an Overfeeding
- ClinicalTrials.gov ID
- NCT00905892
- Acronym / sponsor ID
- SURNUT / CRNHRA-09-002
- Conditions
- Obesity, Lipid Metabolism, Inflammation
- Keywords
- overfeeding, stable isotopes, lipoprotein metabolism, lipid oxidation, fat distribution, gene expression, endotoxemia, mass spectrometry/gas chromatography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-AlpeUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 May 2009 (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 determine the partitioning of exogenous lipids in the postprandial period while a study of overfeeding. The method is based on the incorporation of a stable isotopic tracer (d31_palmitic acid, d31_C16) in lipoprotein triglycerides (TG-CHYLOMICRON and TG-VLDL) and in free fatty acids (FFA).
Detailed description
Healthy overweight and lean young men are subjected to an overfeeding during 56 days which corresponds to a supplement of 761 Kcal/day. During two exploration days (before : D0 et after : D56 overfeeding) they have ingested a breakfast with tracer (d31_palmitic acid, d31_C16, 20mg/kg) and blood and urine samples were collected every hour of each exploration day. The enrichment in deuterium was measured by gas chromatography-organic mass spectrometry (GC-OMS) in palmitic acid pool of lipid fractions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 55 years old
- BMI 18 to 30 kg/m²
- Stable physical activity
- Safety subject during medical consultation
Key exclusion criteria (6 listed)
- Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflammatory diseases)
- Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones)
- Eating disorder
- Intensive sportive activity
- Subjects who Smoke
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 |
|---|---|---|
| Hyperlipidic overfeeding100g per day of cheese + 40g per day of almonds + 20g per day of butter | Dietary supplement | – |
Primary outcome
Post prandial partitioning of exogenous lipids
Time frame: Before and after overfeeding
1 secondary outcome
Genes expression in adipose and muscle tissues
Time frame: Before and after overfeeding
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 23 Jun 2011.
- Derived from this study: PubMed 30260393Segrestin B, Moreno-Navarrete JM, Seyssel K, Alligier M, Meugnier E, Nazare JA, Vidal H, Fernandez-Real JM, Laville M. Adipose Tissue Expansion by Overfeeding Healthy Men Alters Iron Gene Expression. J Clin Endocrinol Metab. 2019 Mar 1;104(3):688-696. doi: 10.1210/jc.2018-01169.
- Derived from this study: PubMed 24684464Seyssel K, Alligier M, Meugnier E, Chanseaume E, Loizon E, Canto C, Disse E, Lambert-Porcheron S, Brozek J, Blond E, Rieusset J, Morio B, Laville M, Vidal H. Regulation of energy metabolism and mitochondrial function in skeletal muscle during lipid overfeeding in healthy men. J Clin Endocrinol Metab. 2014 Jul;99(7):E1254-62. doi: 10.1210/jc.2013-4379. Epub 2014 Mar 31.
- Derived from this study: PubMed 22162470Alligier M, Meugnier E, Debard C, Lambert-Porcheron S, Chanseaume E, Sothier M, Loizon E, Hssain AA, Brozek J, Scoazec JY, Morio B, Vidal H, Laville M. Subcutaneous adipose tissue remodeling during the initial phase of weight gain induced by overfeeding in humans. J Clin Endocrinol Metab. 2012 Feb;97(2):E183-92. doi: 10.1210/jc.2011-2314. Epub 2011 Dec 7.
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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.
Martine Laville, PhD, MD study director
Centre de Recherche en Nutrition Humaine Rhone-Alpe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperlipidic overfeeding in people with Obesity and Lipid Metabolism, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe at 1 site in France.
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 6 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 23 Jun 2011. 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 France. 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?
Post prandial partitioning of exogenous lipids (time frame: Before and after overfeeding). 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 NCT00905892, which also lists 3 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 23 Jun 2011.