OverweightPhase 1NCT00254215
Glycemic Load, Weight Loss and Cardiovascular Disease Risk
A Phase 1 study testing high protein & low glycemic index diets in people with Overweight and Obesity, run by University of Sydney at 1 site in Australia.
Trial summary
To investigate the hypothesis that reducing the glycemic load of the diet will improve changes in body composition and cardio-vascular risk factors. The study compares a conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load: changing the carbohydrates to low-GI choices, replacing some… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- high protein & low glycemic index diets
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2002to Oct 2004
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years of age BMI >=25 stable weight for 3 months non-vegetarian good understanding of English
Who cannot join
- medications other than the contraceptive pill weight >150kg (weight limit of DEXA machine) vegetarian (diets included red meat) specific diets diabetes or impaired glucose tolerance pregnancy
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 4 Diets Varying in Glycemic Index, Glycemic Load, Carbohydrate and Protein, on Weight, Body Composition and Cardio-Vascular Risk Factors
To investigate the hypothesis that reducing the glycemic load of the diet will improve changes in body composition and cardio-vascular risk factors. The study compares a conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load: changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with protein, or combining both effects to produce the lowest glycemic load.
Read the detailed description
Conventional low fat diets produce modest wegiht loss at best and the results are not well maintained. More recently there has been interest in low glycemic index and high protien diets wiht some evidence that these produce better fat loss and improvement in cardiovascular risk factors. This trial aims to evaluate these different approaches and compare the outcomes over 12 weeks. Major outcomes are weigth loss, body composition change, blood lipids change, measures of glucose homeostasis, insulin resistance, leptin and CRP.
- Conditions
- Overweight, Obesity
- Being tested
- high protein & low glycemic index diets
- Keywords
- overweight, obesity, glycemic index, glycemic load, high protein diet, blood cholesterol
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high protein & low glycemic index dietsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss at 12 weeks
Fat loss at 12 weeks
Lean mass change at 12 weeks
Secondary outcomes (5)
Total cholesterol, LDL and HDL cholesterol change at 12 weeks
glucose, insulin & measures of insulin sensitivity change at 12 weeks
TG change at 12 weeks
Leptin change at 12 weeks
CRP change at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startMar 2002
- Study completionOct 2004
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Meat & Livestock Australia, National Heart Foundation, Australia
- Investigators
- Jennie C Brand-Miller, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254215
- Sponsor's protocol ID
- NHF G02S 0768 - Brand-Miller
- Status last verified
- Jul 2005
- First submitted
- 13 Nov 2005
- Last updated
- 28 Nov 2006
- Results posted
- No
Publications
McMillan-Price J, Petocz P, Atkinson F, O'neill K, Samman S, Steinbeck K, Caterson I, Brand-Miller J. Comparison of 4 diets of varying glycemic load on weight loss and cardiovascular risk reduction in overweight and obese young adults: a randomized controlled trial. Arch Intern Med. 2006 Jul 24;166(14):1466-75. doi: 10.1001/archinte.166.14.1466.
PubMed 16864756
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 4 Diets Varying in Glycemic Index, Glycemic Load, Carbohydrate and Protein, on Weight, Body Composition and Cardio-Vascular Risk Factors
- ClinicalTrials.gov ID
- NCT00254215
- Acronym / sponsor ID
- NHF G02S 0768 - Brand-Miller
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity, glycemic index, glycemic load, high protein diet, blood cholesterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Meat & Livestock Australia, National Heart Foundation, Australia
- Study start
- Mar 2002
- Study completion
- Oct 2004
- First posted
- 15 Nov 2005 (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.
To investigate the hypothesis that reducing the glycemic load of the diet will improve changes in body composition and cardio-vascular risk factors. The study compares a conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load: changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with protein, or combining both effects to produce the lowest glycemic load.
Detailed description
Conventional low fat diets produce modest wegiht loss at best and the results are not well maintained. More recently there has been interest in low glycemic index and high protien diets wiht some evidence that these produce better fat loss and improvement in cardiovascular risk factors. This trial aims to evaluate these different approaches and compare the outcomes over 12 weeks. Major outcomes are weigth loss, body composition change, blood lipids change, measures of glucose homeostasis, insulin resistance, leptin and CRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-40 years of age BMI >=25 stable weight for 3 months non-vegetarian good understanding of English
Key exclusion criteria (2 listed)
- medications other than the contraceptive pill weight >150kg (weight limit of DEXA machine) vegetarian (diets included red meat) specific diets diabetes or impaired glucose tolerance pregnancy
- -
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 & low glycemic index diets | Behavioural | – |
Primary outcome
weight loss at 12 weeks
Fat loss at 12 weeks
Lean mass change at 12 weeks
5 secondary outcomes
Total cholesterol, LDL and HDL cholesterol change at 12 weeks
glucose, insulin & measures of insulin sensitivity change at 12 weeks
TG change at 12 weeks
Leptin change at 12 weeks
CRP change at 12 weeks
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 Nov 2006.
- Results publication: PubMed 16864756McMillan-Price J, Petocz P, Atkinson F, O'neill K, Samman S, Steinbeck K, Caterson I, Brand-Miller J. Comparison of 4 diets of varying glycemic load on weight loss and cardiovascular risk reduction in overweight and obese young adults: a randomized controlled trial. Arch Intern Med. 2006 Jul 24;166(14):1466-75. doi: 10.1001/archinte.166.14.1466.
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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.
Jennie C Brand-Miller, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing high protein & low glycemic index diets in people with Overweight and Obesity, run by University of Sydney 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 2 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 Nov 2006. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
weight loss at 12 weeks. The study lists 3 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 NCT00254215, 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 28 Nov 2006.