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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02626325
Other study ID # CHO-MUFA Meta
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 7, 2015
Last updated July 4, 2016
Start date November 2015
Est. completion date July 2016

Study information

Verified date July 2016
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Randomized controlled trials

- Parallel or Crossover Design

- Duration: at least 3 weeks

- Isocaloric diet

Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
High-carbohydrate or High-monounsaturated fat diets


Locations

Country Name City State
Canada Vladimir Vuksan Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure 3 weeks No
Primary Mean arterial pressure 3 weeks No
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