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Effect of Glycemic Load on Body Composition

This study has been terminated.
(Higher drop out than expected. Lower Statistical Power.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603655
First Posted: January 29, 2008
Last Update Posted: December 31, 2008
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.
Information provided by:
Universidad Autonoma de Baja California
  Purpose
The aim of this study is to compare the effects of diets with different glycemic load (GL) on body composition and biochemical markers in overweight and obese subjects during a 12-month period.

Condition Intervention Phase
Overweight Obesity Other: Low glycemic load diet Other: High glycemic load diet Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Assessment of Glycemic Load on Body Composition Among Overweight and Obese Adults During 12 Month Period

Further study details as provided by Universidad Autonoma de Baja California:

Primary Outcome Measures:
  • Reduction of body fat percentage [ Time Frame: 3, 6, 9 and 12 months ]

Secondary Outcome Measures:
  • Reduction of homeostasis model assessment (HOMA) [ Time Frame: 3, 6, 9 and 12 months ]

Enrollment: 29
Study Start Date: January 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
This group will receive a low glycemic load
Other: Low glycemic load diet
Low glycemic load diet
Other Name: Low glycemic index
Active Comparator: B
This group will receive a high glycemic load
Other: High glycemic load diet
High glycemic load diet

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Overweight or obese adults

Exclusion Criteria:

  • Subjects who are pregnant or have diabetes, cancer, psychiatric disorders or physical disabilities
  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): NCT00603655


Locations
Mexico
Facultad de Medicina y Psicología
Tijuana, Baja California, Mexico, 22390
Sponsors and Collaborators
Universidad Autonoma de Baja California
Investigators
Principal Investigator: Arturo Jimenez-Cruz, MD Universidad Autonoma de Baja California
  More Information

Responsible Party: Arturo Jiménez-Cruz, Universidad Autónoma de Baja California
ClinicalTrials.gov Identifier: NCT00603655     History of Changes
Other Study ID Numbers: UABC4268
UABC20074268
First Submitted: January 16, 2008
First Posted: January 29, 2008
Last Update Posted: December 31, 2008
Last Verified: December 2008

Keywords provided by Universidad Autonoma de Baja California:
Diet
glycemic load
overweight
obesity
hyperlipidemia

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms