ObesityNCT01176084
Low Carb Diets & Exercise for Cardiovascular Disease (CVD) Reduction
A study testing low carbohydrate diet and low carbohydrate diet and exercise in people with Obesity, run by University of Surrey at 1 site in United Kingdom.
Trial summary
The purposes of this study are: To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of heart health including blood fats, blood clotting factors, inflammatory markers and levels of body fat. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- low carbohydrate diet and low carbohydrate diet and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2004to Feb 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 21 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- 21-65 years
- body mass index (BMI) 27-40kg/m2
- not currently losing weight
- physically able to exercise at moderate intensity
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Faculty of Health and Medical Sciences, University of Surrey
Guildford, Surrey, GU2 7XH
About this study
Official title: The Efficacy of a Low Carbohydrate Diet, With and Without Exercise, on Cardiovascular Disease Risk in Obese Men
The purposes of this study are:
To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of heart health including blood fats, blood clotting factors, inflammatory markers and levels of body fat.
To investigate the added effect on heart health that regular moderate exercise may have when combined with a low carbohydrate diet in obese men.
- Conditions
- Obesity
- Being tested
- low carbohydrate diet, low carbohydrate diet and exercise
- Keywords
- low carbohydrate diet, obesity, moderate exercise, men
- Medical subject headings
- Obesity, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low carbohydrate dietBehavioural
low carbohydrate diet and exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| low carbohydrate diet | Experimental | Not described Receives: Behavioral: low carbohydrate diet |
| diet & exercise | Experimental | Not described Receives: Behavioral: low carbohydrate diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin levels
Secondary outcomes (3)
body composition
lipid profile
body weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJan 2004
- Primary completionOct 2007
- Study completionFeb 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.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Investigators
- Rebecca Hiscutt, PhD, Principal investigator, University of SurreyHelen D Truby, PhD, Study director, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176084
- Sponsor's protocol ID
- Lowcarbex_v1
- Status last verified
- Jul 2010
- First submitted
- 4 Aug 2010
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Low Carbohydrate Diet, With and Without Exercise, on Cardiovascular Disease Risk in Obese Men
- ClinicalTrials.gov ID
- NCT01176084
- Acronym / sponsor ID
- Lowcarbex_v1
- Conditions
- Obesity
- Keywords
- low carbohydrate diet, obesity, moderate exercise, men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Jan 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Aug 2010 (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 purposes of this study are:
To investigate the effects of a 6 month low carbohydrate diet in obese men on markers of heart health including blood fats, blood clotting factors, inflammatory markers and levels of body fat.
To investigate the added effect on heart health that regular moderate exercise may have when combined with a low carbohydrate diet in obese men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low carbohydrate diet | Experimental | Behavioral: low carbohydrate diet |
| diet & exercise | Experimental | Behavioral: low carbohydrate diet and exercise |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male
- 21-65 years
- body mass index (BMI) 27-40kg/m2
- not currently losing weight
- physically able to exercise at moderate intensity
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| low carbohydrate diet | Behavioural | low carbohydrate diet |
| low carbohydrate diet and exercise | Behavioural | diet & exercise |
Primary outcome
insulin levels
3 secondary outcomes
body composition
lipid profile
body weight
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 20 Aug 2010.
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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.
Rebecca Hiscutt, PhD principal investigator
University of Surrey
Helen D Truby, PhD study director
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low carbohydrate diet and low carbohydrate diet and exercise in people with Obesity, run by University of Surrey at 1 site in United Kingdom.
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 5 inclusion and 0 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 20 Aug 2010. 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 United Kingdom. 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?
insulin levels. 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 20 Aug 2010.