ObesityNCT00625235
A High Protein Diet and Weight Maintenance
A study testing VLED followed by a high protein or high carbohydrate diet in people with Obesity, run by University of Melbourne at 1 site in Australia.
Trial summary
An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- VLED followed by a high protein or high carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2003to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- healthy men and women with a BMI >27kg/m2 with co-morbities or BMI >30kg/m2
Who cannot join
- people with Type II diabetes or other endocrine disorders, women who were pregnant or breastfeeding or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
Australia1 site
Department of Medicine, Heidelberg Repatriation Hospital
Heidelberg, Victoria, 3081
About this study
Official title: The Use of a High Protein Diet in Achieving Long-Term Weight Loss and Improved Cardiovascular Risk Factors
An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.
- Conditions
- Obesity
- Being tested
- VLED followed by a high protein or high carbohydrate diet
- Keywords
- Obesity, Weight loss, Weight maintenance, VLED
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLED followed by a high protein or high carbohydrate dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | High Carbohydrate diet Receives: Dietary Supplement: VLED followed by a high protein or high carbohydrate diet |
| 2 | Other | High Protein diet Receives: Dietary Supplement: VLED followed by a high protein or high carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: 12 months
Secondary outcomes (1)
Cardiovascular risk factors
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startJul 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Meat and Livestock Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625235
- Sponsor's protocol ID
- HREC 2003.046
- Status last verified
- Jun 2003
- First submitted
- 19 Feb 2008
- Last updated
- 28 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a High Protein Diet in Achieving Long-Term Weight Loss and Improved Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT00625235
- Acronym / sponsor ID
- HREC 2003.046
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, Weight maintenance, VLED
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Meat and Livestock Australia
- Study start
- Jul 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Dietary Supplement: VLED followed by a high protein or high carbohydrate dietHigh Carbohydrate diet |
| 2 | Other | Dietary Supplement: VLED followed by a high protein or high carbohydrate dietHigh Protein diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy men and women with a BMI >27kg/m2 with co-morbities or BMI >30kg/m2
Key exclusion criteria (1 listed)
- people with Type II diabetes or other endocrine disorders, women who were pregnant or breastfeeding or planning to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLED followed by a high protein or high carbohydrate diet | Dietary supplement | 1, 2 |
Primary outcome
Body weight
Time frame: 12 months
1 secondary outcome
Cardiovascular risk factors
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VLED followed by a high protein or high carbohydrate diet in people with Obesity, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2008.