ObesityNCT00870259
Investigating Physiological Adaptations to Weight Loss
A study testing Optifast VLCD in people with Obesity, run by University of Melbourne at 1 site in Australia.
Trial summary
The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Optifast VLCD
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2008to Dec 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males and post-menopausal females
- aged over 18 years
- BMI 27-40kg/m2
- weight-stable
Who cannot join
- major comorbid medial condition (including diabetes)
- taking medications known to affect weight
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss
The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.
- Conditions
- Obesity
- Being tested
- Optifast VLCD
- Keywords
- Weight loss, Weight maintenance
- 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.
Optifast VLCDDietary supplement
Meal replacement, three times daily for 8 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline
Measured: 2, 6 and 12 months
Secondary outcomes (3)
Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state
Measured: week 8 vs week 10
Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety
Measured: 0, 2, 6 and 12 months
Association of psychosocial factors with successful weight maintenance
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 posted27 Mar 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priya Sumithran, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870259
- Sponsor's protocol ID
- HP 508920
- Status last verified
- Dec 2014
- First submitted
- 26 Mar 2009
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
PubMed 22029981
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss
- ClinicalTrials.gov ID
- NCT00870259
- Acronym / sponsor ID
- HP 508920
- Conditions
- Obesity
- Keywords
- Weight loss, Weight maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Mar 2009 (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.
The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- males and post-menopausal females
- aged over 18 years
- BMI 27-40kg/m2
- weight-stable
Key exclusion criteria (3 listed)
- major comorbid medial condition (including diabetes)
- taking medications known to affect weight
- smoking
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 |
|---|---|---|
| Optifast VLCDMeal replacement, three times daily for 8 weeks | Dietary supplement | – |
Primary outcome
Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline
Time frame: 2, 6 and 12 months
3 secondary outcomes
Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state
Time frame: week 8 vs week 10
Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety
Time frame: 0, 2, 6 and 12 months
Association of psychosocial factors with successful weight maintenance
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 5 Dec 2014.
- Derived from this study: PubMed 22029981Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604. doi: 10.1056/NEJMoa1105816.
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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 Optifast VLCD 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 4 inclusion and 3 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 5 Dec 2014. 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?
Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline (time frame: 2, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870259, which also lists 1 linked publication.
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 5 Dec 2014.