NCT00603655

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 31, 2008

Status Verified

December 1, 2008

Enrollment Period

1.9 years

First QC Date

January 16, 2008

Last Update Submit

December 30, 2008

Conditions

OverweightObesity

Keywords

Dietglycemic loadoverweightobesityhyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Reduction of body fat percentage

    3, 6, 9 and 12 months

Secondary Outcomes (1)

  • Reduction of homeostasis model assessment (HOMA)

    3, 6, 9 and 12 months

Study Arms (2)

A

EXPERIMENTAL

This group will receive a low glycemic load

Other: Low glycemic load diet

B

ACTIVE COMPARATOR

This group will receive a high glycemic load

Other: High glycemic load diet

Interventions

Low glycemic load dietOTHER

Low glycemic load diet

Also known as: Low glycemic index
A
High glycemic load dietOTHER

High glycemic load diet

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight or obese adults

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Medicina y Psicología

Tijuana, Estado de Baja California, 22390, Mexico

Location

MeSH Terms

Conditions

OverweightObesityHyperlipidemias

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Study Officials

  • Arturo Jimenez-Cruz, MD

    Universidad Autonoma de Baja California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 31, 2008

Record last verified: 2008-12

Locations

ME(1)