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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: CARB rich diet; Other: MUFA rich diet; Other: PROT rich diet

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 Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Baseline; Baseline corresponds to typical American diet	Other: CARB rich diet; Consumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention; Other: MUFA rich diet; Consumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention; Other: PROT rich diet; Consumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
Active Comparator: PROT rich diet; Protein rich diet for 6 weeks	Other: CARB rich diet; Consumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention; Other: MUFA rich diet; Consumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
Active Comparator: MUFA rich diet; MUFA rich diet for 6 weeks	Other: CARB rich diet; Consumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention; Other: PROT rich diet; Consumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
Active Comparator: CARB rich diet; CARB rich diet for 6 weeks	Other: MUFA rich diet; Consumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention; Other: PROT rich diet; Consumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure (SBP)	SBP reduction in mmHg	post 6 weeks intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Kent

Publications and helpful links

General Publications

• Loo RL, Zou X, Appel LJ, Nicholson JK, Holmes E. Characterization of metabolic responses to healthy diets and association with blood pressure: application to the Optimal Macronutrient Intake Trial for Heart Health (OmniHeart), a randomized controlled study. Am J Clin Nutr. 2018 Mar 1;107(3):323-334. doi: 10.1093/ajcn/nqx072.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): July 31, 2015
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 11/LO/0773; G1002151 (Other Grant/Funding Number: MRC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No