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Completed

NCT Number: NCT03369535

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARB rich diet

Other

Consumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention

MUFA rich diet

Other

Consumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention

PROT rich diet

Other

Consumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention

Primary outcomes

  1. Systolic blood pressure (SBP)

    Time frame: post 6 weeks intervention

    SBP reduction in mmHg

Secondary outcomes

  1. Diastolic blood pressure (DBP)

    Time frame: post 6 weeks intervention

    DBP reduction in mmHg

  2. low density lipoprotein cholesterol (LDL)

    Time frame: post 6 weeks intervention

    LDL reduction in mg/dl

  3. high density lipoprotein cholesterol (HDL)

    Time frame: post 6 weeks intervention

    HDL reduction in mg/dl

  4. triglycerides (TG)

    Time frame: post 6 weeks intervention

    TG reduction in mg/dl

  5. total cholesterol

    Time frame: post 6 weeks intervention

    reduction in mg/dl

Sponsors and collaborators

Lead sponsor

University of Kent

Other

Registry information

Official study title

Urinary Metabolic Phenotyping of Diet-cardiovascular Disease Risk Associations: the OmniHeart Feeding Trial

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Dec 12, 2017
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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