NCT01312740

Brief Summary

The investigators evaluated whether an energy-restricted protein diet with low glycaemic index carbohydrates and soluble fibers (LC-P-LGI) would be more effective than a conventional diet (LC-CONV) on weight-loss and related metabolic variables.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2007

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

May 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
Last Updated

March 11, 2011

Status Verified

March 1, 2011

Enrollment Period

7 months

First QC Date

March 9, 2011

Last Update Submit

March 10, 2011

Conditions

Obesity

Keywords

obesitydietary treatmenthigh protein dietLow glycaemic indexadipocytesfat masssystemic inflammatory markersimprovement of complicationseffect on weight loss

Interventions

LC-P-LGI dietOTHER

a hypocaloric diet low in lipids (25%) which is compensated by proteins (35%) with no change in carbohydrate content.

LC-CONVOTHER

4-week CONV period consisted in the subjects' consumption of 1200 Kcal/ day (25% protein, 31% lipids, 44% carbohydrates).

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 26 to 35 Kg/m2
  • to 60 years old
  • non diabetic subjects

You may not qualify if:

  • SGOT and SGPT \>2.5x the normal
  • plasma glucose more than 1.26 g/l
  • hepatic or renal or cardiac failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistant pubique-hopitaux Paris

Paris, 75004, France

Location

Related Publications (1)

  • Rizkalla SW, Prifti E, Cotillard A, Pelloux V, Rouault C, Allouche R, Laromiguiere M, Kong L, Darakhshan F, Massiera F, Clement K. Differential effects of macronutrient content in 2 energy-restricted diets on cardiovascular risk factors and adipose tissue cell size in moderately obese individuals: a randomized controlled trial. Am J Clin Nutr. 2012 Jan;95(1):49-63. doi: 10.3945/ajcn.111.017277. Epub 2011 Dec 14.

    PMID: 22170375DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 11, 2011

Study Start

May 1, 2007

Primary Completion

December 1, 2007

Study Completion

July 1, 2008

Last Updated

March 11, 2011

Record last verified: 2011-03

Locations

FR(1)