Metabolic Fate Modifications of Saturated Fats After an O... | NCT00905892

Studies
Metabolic Fate Modifications of Saturated Fats After an Overfeeding

NCT00905892

Sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Obesity
Lipid Metabolism
Inflammation

Interventions

Hyperlipidic overfeeding

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

May 20, 2009

First Submission Date that Met QC Criteria

May 20, 2009

First Posted Date

May 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centre de Recherche en Nutrition Humaine Rhone-AlpeOTHER

Collaborators

Name	Class
Institut National de la Santé Et de la Recherche Médicale, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 (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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperlipidic overfeeding	Dietary Supplement	100g per day of cheese + 40g per day of almonds + 20g per day of butter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post prandial partitioning of exogenous lipids		Before and after overfeeding

Secondary Outcomes

Measure	Description	Time Frame
Genes expression in adipose and muscle tissues		Before and after overfeeding

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 55 years old
BMI 18 to 30 kg/m²
Stable physical activity
Safety subject during medical consultation

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martine Laville, PhD, MD	Centre de Recherche en Nutrition Humaine Rhone-Alpe	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de recherche en nutrition humaine Rhone-Alpes		Pierre-Bénite		69495	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30260393	Derived	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.
24684464	Derived	Seyssel 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.

ID	Term
D009765	Obesity
D007249	Inflammation
D019446	Endotoxemia

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases