CompletedNCT03369535Updated Dec 12, 2017

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

An interventional study of CARB rich diet and MUFA rich diet in Hypertension, sponsored by University of Kent. Completed. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-12.

Sponsored by University of Kent · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 6 years 2 months after the study started (first participant enrolled Oct 2011, registered Dec 2017).

Phase: Not applicable
Study type: Interventional
Enrollment: 158
Allocation: Randomized
Ages: 30 Years to 80 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Hypertension

Browse trials for

Hypertension 6,114

Keywords

hypertension

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 158 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Kent is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

CVD or diabetes

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 158 participants (actual)

Study arms

Placebo comparator
Baseline
Baseline corresponds to typical American diet
Other: CARB rich diet · Other: MUFA rich diet · Other: PROT rich diet
Active comparator
PROT rich diet
Protein rich diet for 6 weeks
Other: CARB rich diet · Other: MUFA rich diet
Active comparator
MUFA rich diet
MUFA rich diet for 6 weeks
Other: CARB rich diet · Other: PROT rich diet
Active comparator
CARB rich diet
CARB rich diet for 6 weeks
Other: MUFA rich diet · Other: PROT rich diet

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

What researchers measure

Primary outcomes

Systolic blood pressure (SBP)
SBP reduction in mmHg
Time frame: post 6 weeks intervention

Secondary outcomes

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

Study locations

No study locations are listed for this record.

References and documents

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. PubMed 29506183 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2011 to primary completion in Jul 2015, 45 months.

Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 45 months is above that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 6, 2017
First posted: Dec 12, 2017
StartActual: Oct 1, 2011
Primary completionActual: Jul 31, 2015
CompletionActual: Dec 1, 2017
Last update: Dec 12, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03369535
Lead sponsor: University of Kent
Responsible party: Sponsor
First posted: Dec 12, 2017
Start date: Oct 1, 2011
Primary completion: Jul 31, 2015
Completion: Dec 1, 2017
Last update: Dec 12, 2017

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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