NCT00625235

Brief Summary

An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2003

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
Last Updated

February 28, 2008

Status Verified

June 1, 2003

Enrollment Period

2.5 years

First QC Date

February 19, 2008

Last Update Submit

February 19, 2008

Conditions

Obesity

Keywords

ObesityWeight lossWeight maintenanceVLED

Outcome Measures

Primary Outcomes (1)

  • Body weight

    12 months

Secondary Outcomes (1)

  • Cardiovascular risk factors

    12 months

Study Arms (2)

1

OTHER

High Carbohydrate diet

Dietary Supplement: VLED followed by a high protein or high carbohydrate diet

2

OTHER

High Protein diet

Dietary Supplement: VLED followed by a high protein or high carbohydrate diet

Interventions

VLED followed by a high protein or high carbohydrate dietDIETARY_SUPPLEMENT
12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy men and women with a BMI \>27kg/m2 with co-morbities or BMI \>30kg/m2

You may not qualify if:

  • people with Type II diabetes or other endocrine disorders, women who were pregnant or breastfeeding or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Heidelberg Repatriation Hospital

Heidelberg, Victoria, 3081, Australia

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

July 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

February 28, 2008

Record last verified: 2003-06

Locations

AU(1)