Blood PressureCHO-MUFANCT02626325
Effect of High-carbohydrate or High-monounsaturated Fat on Blood Pressure: Meta-analysis of Randomized Clinical Trials
An observational study of Blood Pressure, run by Unity Health Toronto at 1 site in Canada.
Trial summary
High saturated fat acids diets are associated with elevated blood pressure which is associated with cardiovascular morbidity and mortality. For this reason, a change of diet is recommended to manage blood pressure and prevent cardiovascular complications. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- High-carbohydrate or High-monounsaturated fat diets
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Jul 2016
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy and unhealthy (T2DM, hyperlipidemic, hypertensive)
Who may be able to join
- Randomized controlled trials
- Parallel or Crossover Design
- Duration: at least 3 weeks
- Isocaloric diet
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High-carbohydrate or High-monounsaturated Fatty Acids on Blood Pressure: a Meta-analysis of Randomized Clinical Trials
High saturated fat acids diets are associated with elevated blood pressure which is associated with cardiovascular morbidity and mortality. For this reason, a change of diet is recommended to manage blood pressure and prevent cardiovascular complications. To achieve this nutritional goal, a high-carbohydrate diet or high-monounsaturated fat diet can be advised in the replacement of a saturated fat diet.
Previous meta-analysis of Garg (1998) cited randomized articles with inconsistent blood pressure lowering after consumption of a high-monounsaturated-fat diet compared with a high-carbohydrate diet only in type 2 diabetes patients. Moreover, another meta-analysis of Shah et al. (2007) showed slightly high blood pressure on diets rich in carbohydrates than diets rich in cis-monounsaturated fat after randomized and nonrandomized articles.
For this reason, a new meta-analysis of a randomized clinical trial will be performed to clarify the effects of high-carbohydrate or high-monounsaturated fat diets on blood pressure. Results from this meta-analysis will help health professionals take important decisions on patient diet and minimize cardiovascular morbidity and mortality.
- Conditions
- Blood Pressure
- Being tested
- High-carbohydrate or High-monounsaturated fat diets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-carbohydrate or High-monounsaturated fat dietsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 3 weeks
Mean arterial pressure
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
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 Blood PressureStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Unity Health TorontoElena Jovanovskie, MSc, Principal investigator, Unity Health TorontoAny de Castro Ruiz Marques, MSc, Study director, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626325
- Sponsor's protocol ID
- CHO-MUFA Meta
- Acronym
- CHO-MUFA
- Status last verified
- Jul 2016
- First submitted
- 7 Dec 2015
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jovanovski E, de Castro Ruiz Marques A, Li D, Ho HVT, Blanco Mejia S, Sievenpiper JL, Zurbau A, Komishon A, Duvnjak L, Bazotte RB, Vuksan V. Effect of high-carbohydrate or high-monounsaturated fatty acid diets on blood pressure: a systematic review and meta-analysis of randomized controlled trials. Nutr Rev. 2019 Jan 1;77(1):19-31. doi: 10.1093/nutrit/nuy040.
PubMed 30165599
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-carbohydrate or High-monounsaturated Fatty Acids on Blood Pressure: a Meta-analysis of Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT02626325
- Acronym / sponsor ID
- CHO-MUFA / CHO-MUFA Meta
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 10 Dec 2015 (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.
High saturated fat acids diets are associated with elevated blood pressure which is associated with cardiovascular morbidity and mortality. For this reason, a change of diet is recommended to manage blood pressure and prevent cardiovascular complications. To achieve this nutritional goal, a high-carbohydrate diet or high-monounsaturated fat diet can be advised in the replacement of a saturated fat diet.
Previous meta-analysis of Garg (1998) cited randomized articles with inconsistent blood pressure lowering after consumption of a high-monounsaturated-fat diet compared with a high-carbohydrate diet only in type 2 diabetes patients. Moreover, another meta-analysis of Shah et al. (2007) showed slightly high blood pressure on diets rich in carbohydrates than diets rich in cis-monounsaturated fat after randomized and nonrandomized articles.
For this reason, a new meta-analysis of a randomized clinical trial will be performed to clarify the effects of high-carbohydrate or high-monounsaturated fat diets on blood pressure. Results from this meta-analysis will help health professionals take important decisions on patient diet and minimize cardiovascular morbidity and mortality.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy and unhealthy (T2DM, hyperlipidemic, hypertensive)
Key inclusion criteria (4 listed)
- Randomized controlled trials
- Parallel or Crossover Design
- Duration: at least 3 weeks
- Isocaloric diet
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 |
|---|---|---|
| High-carbohydrate or High-monounsaturated fat diets | Other | – |
Primary outcome
Blood pressure
Time frame: 3 weeks
Mean arterial pressure
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Derived from this study: PubMed 30165599Jovanovski E, de Castro Ruiz Marques A, Li D, Ho HVT, Blanco Mejia S, Sievenpiper JL, Zurbau A, Komishon A, Duvnjak L, Bazotte RB, Vuksan V. Effect of high-carbohydrate or high-monounsaturated fatty acid diets on blood pressure: a systematic review and meta-analysis of randomized controlled trials. Nutr Rev. 2019 Jan 1;77(1):19-31. doi: 10.1093/nutrit/nuy040.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
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.
Vladimir Vuksan, PhD principal investigator
Unity Health Toronto
Elena Jovanovskie, MSc principal investigator
Unity Health Toronto
Any de Castro Ruiz Marques, MSc study director
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Unity Health Toronto at 1 site in Canada.
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 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: status not confirmed, as of the sponsor's last update on 6 Jul 2016. 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 Canada. 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?
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?
Blood pressure (time frame: 3 weeks). The study lists 2 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 NCT02626325, 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 6 Jul 2016.