Metabonomics to Investigate Effects of Healthy Diets on Blood Pressure: the OmniHeart Study

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT03369535
• Lead Sponsor: University of Kent

Brief Summary

To compare the urinary metabolomes on individuals undergone three different healthy diets--a carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.

Detailed Description

BACKGROUND:

This study based on the OmniHeart dietary intervention study, a randomized, three period cross-over feeding study that compared the effects on blood pressure and plasma lipids of three DASH-like diets: a carbohydrate-rich (CARB) diet pattern, a rich in protein (PROT) and a rich in unsaturated (MUFA) fat, predominantly monounsaturated fat diet (see full details of OmniHeart dietary intervention https://clinicaltrials.gov/ct2/show/record/NCT00051350).

This metabonomic study aims to evaluate the feasibility of identifying individuals showing variation in clinical response to three different healthy diets, with the purpose of reducing cardiovascular disease (CVD) risk, using proton nuclear magnetic resonance (NMR) based metabolic phenotyping approach.

Study Timeline

• Study Start: 2011-10-01
• Primary Completion: 2015-07-31
• Status Verified: 2017-12
• Study Completion: 2017-12-01
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-06
• Last Update Submitted: 2017-12-06
• Study First Posted: 2017-12-12
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• with pre-hypertension (systolic BP of 120 to 139 mmHg and/or diastolic BP of 80 to 89 mmHg) or stage 1 hypertension (systolic BP of 140 to 159 mm Hg and/or diastolic BP of 90 to 99 mm Hg) and without diabetes or prior CVD

Exclusion Criteria

• CVD or diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure (SBP)	post 6 weeks intervention	SBP reduction in mmHg

Secondary Outcome Measures

Name	Time	Method
high density lipoprotein cholesterol (HDL)	post 6 weeks intervention	HDL reduction in mg/dl
triglycerides (TG)	post 6 weeks intervention	TG reduction in mg/dl
total cholesterol	post 6 weeks intervention	reduction in mg/dl
Diastolic blood pressure (DBP)	post 6 weeks intervention	DBP reduction in mmHg
low density lipoprotein cholesterol (LDL)	post 6 weeks intervention	LDL reduction in mg/dl