OverweightNCT00421616
Effectiveness of High Protein Diets in Promoting Weight Loss in Overweight and Obese Subjects.
A study testing High protein diet study in people with Overweight, run by University of Wollongong at 1 site in Australia.
Trial summary
Several studies have reported greater weight loss when following high meat-protein diets but limited studies have studied high plant-based protein diets. Thus we aim to investigate the effect of high protein diets in weight management and also to investigate the superior protein source in achieving this effect. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- High protein diet study
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2007to not given
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obese
- Age 18 and above
- Both males and females
- Live in Illawarra Area of Australia
Who cannot join
- Regular medication
- Smoker
- Food allergies
- Presence of disease which may alter metabolic rate
Trial locations and contacts
1 site in 1 country.
Australia1 site
Smart Foods Centre, University of Wollongong
Wollongong, New South Wales, 2522
Marijka Batterham, PhD, +61242215303 ext. 5303, marijka@uow.edu.au
Cassandra Quick, MND, +61242215992 ext. 5992, cassy@uow.edu.au
About this study
Official title: A Diet Higher in Animal-Based Protein is More Effective in Promoting Weight Loss in Overweight and Obese Individuals Than Other Protein Based Diets.
Several studies have reported greater weight loss when following high meat-protein diets but limited studies have studied high plant-based protein diets. Thus we aim to investigate the effect of high protein diets in weight management and also to investigate the superior protein source in achieving this effect. In addition, we aim to develop dietary intervention strategies that are realistic and sustainable.
Read the detailed description
Participants will be randomised to either high-protein diets (30% of energy) from animal or plant sources or standard protein diet (15% of energy) weight loss diet for 3 months.
- Conditions
- Overweight
- Being tested
- High protein diet study
- Keywords
- Calorimetry, Overweight, Weight loss, Appetite
- Medical subject headings
- Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein diet studyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight & anthropometric measurements at 0 and 3 months
Energy expenditure
Substrate oxidation
Compliance to diets
Secondary outcomes (2)
Blood lipids
Appetite
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2007 (estimated)
- Study startFeb 2007
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 OverweightStudies 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
- Masking
- Single blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- University of Wollongong
- Sponsor type
- University, hospital or other
- Collaborators
- National Centre of Excellence in Functional Foods, Australia
- Investigators
- Marijka Batterham, PhD, Principal investigator, Smart Foods Centre, University of WollongongLinda Tapsell, PhD, Principal investigator, National Centre of Excellence in Functional Foods, AustraliaArthur Jenkins, PhD, Principal investigator, School of Health Sciences, University of Wollongong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421616
- Sponsor's protocol ID
- HE06/332
- Status last verified
- Feb 2007
- First submitted
- 11 Jan 2007
- Last updated
- 19 Feb 2007
- Results posted
- No
Publications
Tan SY, Batterham M, Tapsell L. Activity counts from accelerometers do not add value to energy expenditure predictions in sedentary overweight individuals during weight loss interventions. J Phys Act Health. 2011 Jul;8(5):675-81. doi: 10.1123/jpah.8.5.675.
PubMed 21734313
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diet Higher in Animal-Based Protein is More Effective in Promoting Weight Loss in Overweight and Obese Individuals Than Other Protein Based Diets.
- ClinicalTrials.gov ID
- NCT00421616
- Acronym / sponsor ID
- HE06/332
- Conditions
- Overweight
- Keywords
- Calorimetry, Overweight, Weight loss, Appetite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- University of WollongongUniversity, hospital or other
- Collaborators
- National Centre of Excellence in Functional Foods, Australia
- Study start
- Feb 2007
- First posted
- 12 Jan 2007 (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.
Several studies have reported greater weight loss when following high meat-protein diets but limited studies have studied high plant-based protein diets. Thus we aim to investigate the effect of high protein diets in weight management and also to investigate the superior protein source in achieving this effect. In addition, we aim to develop dietary intervention strategies that are realistic and sustainable.
Detailed description
Participants will be randomised to either high-protein diets (30% of energy) from animal or plant sources or standard protein diet (15% of energy) weight loss diet for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overweight or obese
- Age 18 and above
- Both males and females
- Live in Illawarra Area of Australia
Key exclusion criteria (4 listed)
- Regular medication
- Smoker
- Food allergies
- Presence of disease which may alter metabolic rate
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 |
|---|---|---|
| High protein diet study | Behavioural | – |
Primary outcome
Weight & anthropometric measurements at 0 and 3 months
Energy expenditure
Substrate oxidation
Compliance to diets
2 secondary outcomes
Blood lipids
Appetite
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2007.
- Derived from this study: PubMed 21734313Tan SY, Batterham M, Tapsell L. Activity counts from accelerometers do not add value to energy expenditure predictions in sedentary overweight individuals during weight loss interventions. J Phys Act Health. 2011 Jul;8(5):675-81. doi: 10.1123/jpah.8.5.675.
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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.
Marijka Batterham, PhD principal investigator
Smart Foods Centre, University of Wollongong
Linda Tapsell, PhD principal investigator
National Centre of Excellence in Functional Foods, Australia
Arthur Jenkins, PhD principal investigator
School of Health Sciences, University of Wollongong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein diet study in people with Overweight, run by University of Wollongong 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 4 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: status not confirmed, as of the sponsor's last update on 19 Feb 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marijka Batterham, PhD (+61242215303 ext. 5303, marijka@uow.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight & anthropometric measurements at 0 and 3 months. The study lists 4 primary outcomes in all. 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 NCT00421616, 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 19 Feb 2007.