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

University of Kent

Status: Completed

Conditions: Hypertension

Treatments: Other: MUFA rich diet; Other: CARB rich diet; Other: PROT rich diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03369535

11/LO/0773

G1002151 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

158 participants in 4 patient groups, including a placebo group

Baseline

Placebo Comparator group

Description:

Baseline corresponds to typical American diet

Treatment:

Other: MUFA rich diet

Other: CARB rich diet

Other: PROT rich diet

PROT rich diet

Active Comparator group

Description:

Protein rich diet for 6 weeks

Treatment:

Other: MUFA rich diet

Other: CARB rich diet

MUFA rich diet

Active Comparator group

Description:

MUFA rich diet for 6 weeks

Treatment:

Other: CARB rich diet

Other: PROT rich diet

CARB rich diet

Active Comparator group

Description:

CARB rich diet for 6 weeks

Treatment:

Other: MUFA rich diet

Other: PROT rich diet