Body Mass Index Quantitative Trait Locus 8 DisorderPhase 3NCT01763528
High Protein Weight Loss Diet, High Sensitivity C-Reactive Protein and Cardiovascular Risks Among Obese Women
A Phase 3 study testing nutrition intervention in people with Body Mass Index Quantitative Trait Locus 8 Disorder and Tangier Disease, run by Isfahan University of Medical Sciences.
Trial summary
The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Mass Index Quantitative Trait Locus 8 Disorder, Tangier Disease
- What is being tested?
- nutrition intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Aug 2012
- Phase
- Phase 3
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women aged between 20-65 years
- BMI > 25 kg/m2
- were no smoker
- no history of renal, liver, metabolic diseases or type 1 or 2 diabetes
Who cannot join
- had gastrointestinal, respiratory, cardiovascular, metabolic, liver and renal -diseases
- had macroalbuminuria
- were pregnancy or lactating
About this study
Official title: High Protein Diet , CRP and CVD Risk Factors
The investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.
Read the detailed description
Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results.
Objective: In present study, we aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.
Design: In this randomized controlled trial, we recruited 60 overweight and obese women, aged 20-65 years into HP or control energy restricted diets for three months (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, hs-CRP, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.
- Being tested
- nutrition intervention
- Keywords
- body weight, Low-density-lipoprotein-type
- Medical subject headings
- Tangier Disease, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition interventionOther
high protein diet
| Study group | Role | What they receive |
|---|---|---|
| nutrition intervention | Active comparator | high protein diet Receives: Other: nutrition intervention |
| control group | No intervention | control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of weight reduction in two dietary groups
weight reduction (kg)
Measured: 3 months
Secondary outcomes (6)
LDL-C (mg/dl
measurement of LDL-C (mg/dl), HDL-C (mg/dl), total cholesterol (mg/dl), fasting blood glucose (mg/dl), systolic and diastolic blood pressure (mmHg), c reactive protein by the measurement of blood samples.
Measured: 3 months
HDL-C (mg/dl)
Measured: 3 months
total cholesterol (mg/dl)
Measured: 3 months
fasting blood glucose(mg/dl)
Measured: 3 months
blood pressure (mmHg)
Measured: 3 months
C-reactive protein (mc/dl)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionAug 2012
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 Body Mass Index Quantitative Trait Locus 8 DisorderStudies 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Azadbakht, Isfahan University of Medical Sciences
- Investigators
- Leila Azadbakht, PhD, Principal investigator, Isfan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763528
- Sponsor's protocol ID
- high protein in women
- Status last verified
- Jan 2013
- First submitted
- 18 Dec 2012
- Last updated
- 9 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Azadbakht L, Izadi V, Surkan PJ, Esmaillzadeh A. Effect of a High Protein Weight Loss Diet on Weight, High-Sensitivity C-Reactive Protein, and Cardiovascular Risk among Overweight and Obese Women: A Parallel Clinical Trial. Int J Endocrinol. 2013;2013:971724. doi: 10.1155/2013/971724. Epub 2013 Aug 6.
PubMed 23986778
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Protein Diet , CRP and CVD Risk Factors
- ClinicalTrials.gov ID
- NCT01763528
- Acronym / sponsor ID
- high protein in women
- Keywords
- body weight, Low-density-lipoprotein-type
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Jan 2013 (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 investigators aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.
Detailed description
Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results.
Objective: In present study, we aimed to determine the effects of HP diet on CVD risk factors and hs-CRP among overweight and obese women.
Design: In this randomized controlled trial, we recruited 60 overweight and obese women, aged 20-65 years into HP or control energy restricted diets for three months (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, hs-CRP, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutrition intervention | Active comparator | Other: nutrition interventionhigh protein diet |
| control group | No intervention | –control diet |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women aged between 20-65 years
- BMI > 25 kg/m2
- were no smoker
- no history of renal, liver, metabolic diseases or type 1 or 2 diabetes
Key exclusion criteria (3 listed)
- had gastrointestinal, respiratory, cardiovascular, metabolic, liver and renal -diseases
- had macroalbuminuria
- were pregnancy or lactating
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 |
|---|---|---|
| nutrition interventionhigh protein diet | Other | nutrition intervention |
Primary outcome
the amount of weight reduction in two dietary groups
Time frame: 3 months
weight reduction (kg)
6 secondary outcomes
LDL-C (mg/dl
Time frame: 3 months
HDL-C (mg/dl)
Time frame: 3 months
total cholesterol (mg/dl)
Time frame: 3 months
fasting blood glucose(mg/dl)
Time frame: 3 months
blood pressure (mmHg)
Time frame: 3 months
C-reactive protein (mc/dl)
Time frame: 3 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 9 Jan 2013.
- Derived from this study: PubMed 23986778Azadbakht L, Izadi V, Surkan PJ, Esmaillzadeh A. Effect of a High Protein Weight Loss Diet on Weight, High-Sensitivity C-Reactive Protein, and Cardiovascular Risk among Overweight and Obese Women: A Parallel Clinical Trial. Int J Endocrinol. 2013;2013:971724. doi: 10.1155/2013/971724. Epub 2013 Aug 6.
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.
Leila Azadbakht, PhD principal investigator
Isfan University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nutrition intervention in people with Body Mass Index Quantitative Trait Locus 8 Disorder and Tangier Disease, run by Isfahan University of Medical Sciences.
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 9 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the amount of weight reduction in two dietary groups (time frame: 3 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 NCT01763528, 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 9 Jan 2013.