Effect of High-carbohydrate or High-monounsaturated Fat on Blood Pressure: Meta-analysis of Randomized Clinical Trials
CHO-MUFA
1 other identifier
observational
1,000
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 6, 2016
July 1, 2016
8 months
December 7, 2015
July 4, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Blood pressure
3 weeks
Mean arterial pressure
3 weeks
Interventions
Eligibility Criteria
Healthy and unhealthy (T2DM, hyperlipidemic, hypertensive)
You may qualify if:
- Randomized controlled trials
- Parallel or Crossover Design
- Duration: at least 3 weeks
- Isocaloric diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vladimir Vuksan
Toronto, Ontario, M5C2T2, Canada
Related Publications (1)
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.
PMID: 30165599DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Vladimir Vuksan, PhD
Unity Health Toronto
- PRINCIPAL INVESTIGATOR
Elena Jovanovskie, MSc
Unity Health Toronto
- STUDY DIRECTOR
Any de Castro Ruiz Marques, MSc
Unity Health Toronto
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2015
First Posted
December 10, 2015
Study Start
November 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
July 6, 2016
Record last verified: 2016-07