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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03369535
Enrollment
158
Registered
2017-12-12
Start date
2011-10-01
Completion date
2017-12-01
Last updated
2017-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension

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.

Interventions

OTHERCARB rich diet

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

OTHERMUFA rich diet

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

OTHERPROT rich diet

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

Sponsors

University of Kent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressure (SBP)post 6 weeks interventionSBP reduction in mmHg

Secondary

MeasureTime frameDescription
Diastolic blood pressure (DBP)post 6 weeks interventionDBP reduction in mmHg
low density lipoprotein cholesterol (LDL)post 6 weeks interventionLDL reduction in mg/dl
high density lipoprotein cholesterol (HDL)post 6 weeks interventionHDL reduction in mg/dl
triglycerides (TG)post 6 weeks interventionTG reduction in mg/dl
total cholesterolpost 6 weeks interventionreduction in mg/dl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026