Effects of Two Hypocaloric Diets on Weight Loss

NCT ID: NCT01312740

Last Updated: 2011-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-07-31

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.

Detailed 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Interventions

LC-P-LGI diet

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

Intervention Type: OTHER

LC-CONV

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Pierre and Marie Curie University

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Ceprodi S.A. Kot

INDUSTRY

Sponsor Role: lead

Responsible Party

Ceprodi S.A. Kot

Locations

Assistant pubique-hopitaux Paris

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 22170375 (View on PubMed)

Other Identifiers

RCB: 2007-A00329-44

Identifier Type: -

Identifier Source: org_study_id