ObesityNCT00383253
Methods Study to Characterize Early Indicators of Weight Loss in People
A study testing caloric restriction - 10%, caloric restriction - 25% and caloric restriction - 50% in people with Obesity, run by Pfizer at 2 sites in Australia.
Trial summary
Methods study to characterize early indicators of weight loss in people. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- caloric restriction - 10%, caloric restriction - 25% and caloric restriction - 50%
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 2 sitesAustralia
- Study dates
- Oct 2006to Mar 2008
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects >=18 years of age with BMI >= 30 and < 40 kg/m2
Who cannot join
- Females, those with illnesses expected to cause weight loss, those without stable body weight within 3 months of screening.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
North Adelaide, South Australia, 5006
About this study
Official title: A Randomized, Open-Label, Parallel Group, Fixed Energy Deficit Methodology Trial to Characterize Early Efficacy Biomarkers During Treatment of Obesity in Adult, Obese, Male Subjects.
Methods study to characterize early indicators of weight loss in people.
- Conditions
- Obesity
- Being tested
- caloric restriction - 10%, caloric restriction - 25%, caloric restriction - 50%, caloric restriction - Control
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caloric restriction - 10%Behavioural
Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)
caloric restriction - 25%Behavioural
Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)
caloric restriction - 50%Behavioural
Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)
caloric restriction - ControlBehavioural
Subjects maintained on their baseline caloric intake (caloric restriction = none)
| Study group | Role | What they receive |
|---|---|---|
| 10% | Experimental | Not described Receives: Behavioral: caloric restriction - 10% |
| 25% | Experimental | Not described Receives: Behavioral: caloric restriction - 25% |
| 50% | Experimental | Not described Receives: Behavioral: caloric restriction - 50% |
| Control | Placebo comparator | Not described Receives: Behavioral: caloric restriction - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers
Measured: Throughout trial
Secondary outcomes (1)
To evaluate the time course, magnitude and biomarkers of metabolic compensation as well as assessment of well being (via questionnaires) following varying degrees of controlled, 1-month, caloric restriction
Measured: Throughout trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startOct 2006
- Study completionMar 2008
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Adelaide, Royal Adelaide Hospital
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383253
- Sponsor's protocol ID
- A9001342
- Status last verified
- Mar 2009
- First submitted
- 29 Sep 2006
- Last updated
- 23 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel Group, Fixed Energy Deficit Methodology Trial to Characterize Early Efficacy Biomarkers During Treatment of Obesity in Adult, Obese, Male Subjects.
- ClinicalTrials.gov ID
- NCT00383253
- Acronym / sponsor ID
- A9001342
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- University of Adelaide, Royal Adelaide Hospital
- Study start
- Oct 2006
- Study completion
- Mar 2008 (actual)
- First posted
- 3 Oct 2006 (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.
Methods study to characterize early indicators of weight loss in people.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10% | Experimental | Behavioral: caloric restriction - 10% |
| 25% | Experimental | Behavioral: caloric restriction - 25% |
| 50% | Experimental | Behavioral: caloric restriction - 50% |
| Control | Placebo comparator | Behavioral: caloric restriction - Control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects >=18 years of age with BMI >= 30 and < 40 kg/m2
Key exclusion criteria (1 listed)
- Females, those with illnesses expected to cause weight loss, those without stable body weight within 3 months of screening.
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 |
|---|---|---|
| caloric restriction - 10%Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline) | Behavioural | 10% |
| caloric restriction - 25%Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline) | Behavioural | 25% |
| caloric restriction - 50%Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline) | Behavioural | 50% |
| caloric restriction - ControlSubjects maintained on their baseline caloric intake (caloric restriction = none) | Behavioural | Control |
Primary outcome
To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers
Time frame: Throughout trial
1 secondary outcome
To evaluate the time course, magnitude and biomarkers of metabolic compensation as well as assessment of well being (via questionnaires) following varying degrees of controlled, 1-month, caloric restriction
Time frame: Throughout trial
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 23 Mar 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caloric restriction - 10%, caloric restriction - 25% and caloric restriction - 50% in people with Obesity, run by Pfizer at 2 sites 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 23 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
To evaluate the effect of varying degrees of controlled, 1-month, caloric restriction on weight loss, and response of known circulating, candidate biomarkers (time frame: Throughout trial). 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 23 Mar 2009.