Effects of Two Hypocaloric Diets on Weight Loss

Obesity Clinical Trial

Official title:

Effects of Two Hypocaloric Diets on Weight Loss and Inflammatory Markers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312740
• Other study ID #: RCB: 2007-A00329-44
• Status: Completed
• Phase: N/A
• First received: March 9, 2011
• Last updated: March 10, 2011
• Start date: May 2007
• Est. completion date: July 2008

Study information

• Verified date: March 2011
• Source: Ceprodi S.A. Kot
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

The subjects (9 men and 5 post-menopausal women) were randomly allocated, in a cross-over design, to two periods of 4 weeks of an energy restricted diet of 1200 kcal as either a conventional diet (LC- CONV) or a special energy restricted diet compensated by proteins (LC-P-LGI). The two nutritional periods were separated by a wash-out interval of 8 weeks. Before the start of the study, all subjects were instructed to maintain their usual lifestyle during the experimental period.Anthropometric parameters, glucose and lipid homeostasis and inflammatory markers were evaluated before and after each dietary period.Body fat and fat-free mass distributions were measured by a dual-energy X-ray absorptiometry (DXA, GE Lunar Prodigy Corporation, Madison, WI, USA) before and after each dietary period at the fasting state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI 26 to 35 Kg/m2

• 25 to 60 years old

• non diabetic subjects

Exclusion Criteria:

• SGOT and SGPT >2.5x the normal

• plasma glucose more than 1.26 g/l

• hepatic or renal or cardiac failure

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• LC-P-LGI diet
a hypocaloric diet low in lipids (25%) which is compensated by proteins (35%) with no change in carbohydrate content.
• LC-CONV
4-week CONV period consisted in the subjects' consumption of 1200 Kcal/ day (25% protein, 31% lipids, 44% carbohydrates).

Locations

Country	Name	City	State
France	Assistant pubique-hopitaux Paris	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Ceprodi S.A. Kot	Assistance Publique - Hôpitaux de Paris, Institut National de la Santé Et de la Recherche Médicale, France, Pierre and Marie Curie University

Country where clinical trial is conducted

France,