NCT00905892

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

4.3 years

First QC Date

May 20, 2009

Last Update Submit

June 22, 2011

Conditions

Keywords

overfeedingstable isotopeslipoprotein metabolismlipid oxidationfat distributiongene expressionendotoxemiamass spectrometry/gas chromatography

Outcome Measures

Primary Outcomes (1)

  • Post prandial partitioning of exogenous lipids

    Before and after overfeeding

Secondary Outcomes (1)

  • Genes expression in adipose and muscle tissues

    Before and after overfeeding

Interventions

Hyperlipidic overfeedingDIETARY_SUPPLEMENT

100g per day of cheese + 40g per day of almonds + 20g per day of butter

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche en nutrition humaine Rhone-Alpes

Pierre-Bénite, 69495, France

Location

Related Publications (3)

  • 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.

  • 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.

  • Alligier 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.

MeSH Terms

Conditions

ObesityInflammationEndotoxemia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesBacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response Syndrome

Study Officials

  • Martine Laville, PhD, MD

    Centre de Recherche en Nutrition Humaine Rhône-Alpes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

September 1, 2005

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations