MedDataX Logo

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

NCT ID: NCT03369535

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-01

Study Completion Date

2017-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Baseline

Baseline corresponds to typical American diet

Group Type PLACEBO_COMPARATOR

CARB rich diet

Intervention Type OTHER

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

MUFA rich diet

Intervention Type OTHER

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

PROT rich diet

Intervention Type OTHER

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

PROT rich diet

Protein rich diet for 6 weeks

Group Type ACTIVE_COMPARATOR

CARB rich diet

Intervention Type OTHER

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

MUFA rich diet

Intervention Type OTHER

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

MUFA rich diet

MUFA rich diet for 6 weeks

Group Type ACTIVE_COMPARATOR

CARB rich diet

Intervention Type OTHER

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

PROT rich diet

Intervention Type OTHER

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

CARB rich diet

CARB rich diet for 6 weeks

Group Type ACTIVE_COMPARATOR

MUFA rich diet

Intervention Type OTHER

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

PROT rich diet

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CARB rich diet

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

Intervention Type OTHER

MUFA rich diet

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

Intervention Type OTHER

PROT rich diet

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Kent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29506183 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

G1002151

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

11/LO/0773

Identifier Type: -

Identifier Source: org_study_id