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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Other: CARB rich diet
* Other: MUFA rich diet
* Other: PROT rich diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension