NCT01314690

Brief Summary

The objectives of this study are: 1-To qualify the relationship between the gut microbiota and the host nutritional and metabolic status during dietary transition.2-To define the impact of nutritional transition on the intestinal microbiota and identify metagenomics signatures of nutritional transition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2008

Typical duration 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, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
Last Updated

March 14, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

March 9, 2011

Last Update Submit

March 11, 2011

Conditions

Obesity

Keywords

obesitylow calorie dietintestinal microbiotainflammation (systemic and in adipose tissue)fat massImpact of nutritional transition on intestinal microbiotarelation between food intake, clinical parameters and intestinal microbiota

Outcome Measures

Primary Outcomes (4)

  • weight loss

  • intestinal microbiota genes

    identify new intestinal microbiota at basal levels and follow their evolution during the dietary program by using a sequence based method (SOLiD™ System: a massively sequencing platform).

  • Body fat mass

    using dual-energy X-ray absorptiometry performed with a total body scanner (Hologic QDR 2500 densitometer)

  • Food intake

    using 7 day dietary records at each time point

Secondary Outcomes (2)

  • plasma glucose

  • adipose tissue genes

Interventions

Caloric transitionOTHER

6 week low calorie diet followed by 6 week stabilization period

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 27 to 38 kg/m2
  • age: 25 to 65 years.
  • non diabetic subjects
  • fasting glycemia \< 1,26 g/l

You may not qualify if:

  • SGOT ou SGPT \> 2.5x normale
  • Glycemia \> 1,26 g/l
  • any other health problem or chronic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance publique-hopitaux de Paris

Paris, France

Location

Related Publications (4)

  • Dao MC, Sokolovska N, Brazeilles R, Affeldt S, Pelloux V, Prifti E, Chilloux J, Verger EO, Kayser BD, Aron-Wisnewsky J, Ichou F, Pujos-Guillot E, Hoyles L, Juste C, Dore J, Dumas ME, Rizkalla SW, Holmes BA, Zucker JD, Clement K; MICRO-Obes Consortium. A Data Integration Multi-Omics Approach to Study Calorie Restriction-Induced Changes in Insulin Sensitivity. Front Physiol. 2019 Feb 5;9:1958. doi: 10.3389/fphys.2018.01958. eCollection 2018.

    PMID: 30804813DERIVED

  • Dao MC, Everard A, Aron-Wisnewsky J, Sokolovska N, Prifti E, Verger EO, Kayser BD, Levenez F, Chilloux J, Hoyles L; MICRO-Obes Consortium; Dumas ME, Rizkalla SW, Dore J, Cani PD, Clement K. Akkermansia muciniphila and improved metabolic health during a dietary intervention in obesity: relationship with gut microbiome richness and ecology. Gut. 2016 Mar;65(3):426-36. doi: 10.1136/gutjnl-2014-308778. Epub 2015 Jun 22.

    PMID: 26100928DERIVED

  • Kong LC, Holmes BA, Cotillard A, Habi-Rachedi F, Brazeilles R, Gougis S, Gausseres N, Cani PD, Fellahi S, Bastard JP, Kennedy SP, Dore J, Ehrlich SD, Zucker JD, Rizkalla SW, Clement K. Dietary patterns differently associate with inflammation and gut microbiota in overweight and obese subjects. PLoS One. 2014 Oct 20;9(10):e109434. doi: 10.1371/journal.pone.0109434. eCollection 2014.

    PMID: 25330000DERIVED

  • Kong LC, Wuillemin PH, Bastard JP, Sokolovska N, Gougis S, Fellahi S, Darakhshan F, Bonnefont-Rousselot D, Bittar R, Dore J, Zucker JD, Clement K, Rizkalla S. Insulin resistance and inflammation predict kinetic body weight changes in response to dietary weight loss and maintenance in overweight and obese subjects by using a Bayesian network approach. Am J Clin Nutr. 2013 Dec;98(6):1385-94. doi: 10.3945/ajcn.113.058099. Epub 2013 Oct 30.

    PMID: 24172304DERIVED

MeSH Terms

Conditions

ObesityInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Karine Clement, MD, PhD, Prof

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 14, 2011

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

March 1, 2011

Last Updated

March 14, 2011

Record last verified: 2011-03

Locations

FR(1)