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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:
Information provided by:
Universidad Autonoma de Baja California
ClinicalTrials.gov Identifier:
NCT00603655
First received: January 16, 2008
Last updated: December 30, 2008
Last verified: December 2008
  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
Phase 0

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of homeostasis model assessment (HOMA) [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Arturo Jiménez-Cruz, Universidad Autónoma de Baja California
ClinicalTrials.gov Identifier: NCT00603655     History of Changes
Other Study ID Numbers: UABC4268, UABC20074268
Study First Received: January 16, 2008
Last Updated: December 30, 2008
Health Authority: Mexico: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 24, 2014