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Effects of Two Hypocaloric Diets on Weight Loss

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312740
First Posted: March 11, 2011
Last Update Posted: March 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 9, 2011
First Posted: March 11, 2011
Last Update Posted: March 11, 2011
Last Verified: March 2011

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:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms