NCT02626325

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

8 months

First QC Date

December 7, 2015

Last Update Submit

July 4, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    3 weeks

  • Mean arterial pressure

    3 weeks

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

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.

Study Officials

  • Vladimir Vuksan, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR
  • Elena Jovanovskie, MSc

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR
  • Any de Castro Ruiz Marques, MSc

    Unity Health Toronto

    STUDY DIRECTOR

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

Locations