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Effects of Two Hypocaloric Diets on Weight Loss

This study has been completed.
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Pierre and Marie Curie University
Assistance Publique - Hôpitaux de Paris
Information provided by:
Ceprodi S.A. Kot
ClinicalTrials.gov Identifier:
NCT01312740
First received: March 9, 2011
Last updated: March 10, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Other: LC-P-LGI diet
Other: LC-CONV

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effects of Two Hypocaloric Diets on Weight Loss and Inflammatory Markers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ceprodi S.A. Kot:

Enrollment: 13
Study Start Date: May 2007
Study Completion Date: July 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: LC-P-LGI diet
    a hypocaloric diet low in lipids (25%) which is compensated by proteins (35%) with no change in carbohydrate content.
    Other: LC-CONV
    4-week CONV period consisted in the subjects' consumption of 1200 Kcal/ day (25% protein, 31% lipids, 44% carbohydrates).
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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312740

Locations
France
Assistant pubique-hopitaux Paris
Paris, France, 75004
Sponsors and Collaborators
Ceprodi S.A. Kot
Institut National de la Santé Et de la Recherche Médicale, France
Pierre and Marie Curie University
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Ceprodi S.A. Kot

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Florence Massiera, Ceprodi S.A. Kot
ClinicalTrials.gov Identifier: NCT01312740     History of Changes
Other Study ID Numbers: RCB: 2007-A00329-44
Study First Received: March 9, 2011
Last Updated: March 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Ceprodi S.A. Kot:
obesity
dietary treatment
high protein diet
Low glycaemic index
adipocytes
 fat mass
systemic inflammatory markers
improvement of complications
effect on weight loss

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 17, 2013