HypertensionNCT03369535
Metabonomics to Investigate Effects of Healthy Diets on Blood Pressure: the OmniHeart Study
A study testing CARB rich diet, MUFA rich diet and PROT rich diet in people with Hypertension, run by University of Kent.
Trial 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 more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CARB rich diet, MUFA rich diet and PROT rich diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2011to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- CVD or diabetes
About this study
Official title: 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.
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
- Hypertension
- Being tested
- CARB rich diet, MUFA rich diet, PROT rich diet
- Keywords
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARB rich dietOther
Consumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
MUFA rich dietOther
Consumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
PROT rich dietOther
Consumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
| Study group | Role | What they receive |
|---|---|---|
| Baseline | Placebo comparator | Baseline corresponds to typical American diet Receives: Other: CARB rich diet; Other: MUFA rich diet; Other: PROT rich diet |
| PROT rich diet | Active comparator | Protein rich diet for 6 weeks Receives: Other: CARB rich diet; Other: MUFA rich diet |
| MUFA rich diet | Active comparator | MUFA rich diet for 6 weeks Receives: Other: CARB rich diet; Other: PROT rich diet |
| CARB rich diet | Active comparator | CARB rich diet for 6 weeks Receives: Other: MUFA rich diet; Other: PROT rich diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (SBP)
SBP reduction in mmHg
Measured: post 6 weeks intervention
Secondary outcomes (5)
Diastolic blood pressure (DBP)
DBP reduction in mmHg
Measured: post 6 weeks intervention
low density lipoprotein cholesterol (LDL)
LDL reduction in mg/dl
Measured: post 6 weeks intervention
high density lipoprotein cholesterol (HDL)
HDL reduction in mg/dl
Measured: post 6 weeks intervention
triglycerides (TG)
TG reduction in mg/dl
Measured: post 6 weeks intervention
total cholesterol
reduction in mg/dl
Measured: post 6 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Oct 2011
- Primary completion31 Jul 2015
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369535
- Sponsor's protocol ID
- 11/LO/0773
- Other IDs
- G1002151
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Metabolic Phenotyping of Diet-cardiovascular Disease Risk Associations: the OmniHeart Feeding Trial
- ClinicalTrials.gov ID
- NCT03369535
- Acronym / sponsor ID
- 11/LO/0773
- Conditions
- Hypertension
- Keywords
- hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of KentUniversity, hospital or other
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline | Placebo comparator | Other: CARB rich diet, Other: MUFA rich diet, Other: PROT rich dietBaseline corresponds to typical American diet |
| PROT rich diet | Active comparator | Other: CARB rich diet, Other: MUFA rich dietProtein rich diet for 6 weeks |
| MUFA rich diet | Active comparator | Other: CARB rich diet, Other: PROT rich dietMUFA rich diet for 6 weeks |
| CARB rich diet | Active comparator | Other: MUFA rich diet, Other: PROT rich dietCARB rich diet for 6 weeks |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- CVD or diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARB rich dietConsumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention | Other | Baseline, MUFA rich diet, PROT rich diet |
| MUFA rich dietConsumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention | Other | Baseline, CARB rich diet, PROT rich diet |
| PROT rich dietConsumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention | Other | Baseline, CARB rich diet, MUFA rich diet |
Primary outcome
Systolic blood pressure (SBP)
Time frame: post 6 weeks intervention
SBP reduction in mmHg
5 secondary outcomes
Diastolic blood pressure (DBP)
Time frame: post 6 weeks intervention
low density lipoprotein cholesterol (LDL)
Time frame: post 6 weeks intervention
high density lipoprotein cholesterol (HDL)
Time frame: post 6 weeks intervention
triglycerides (TG)
Time frame: post 6 weeks intervention
total cholesterol
Time frame: post 6 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Derived from this study: PubMed 29506183Loo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CARB rich diet, MUFA rich diet and PROT rich diet in people with Hypertension, run by University of Kent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (SBP) (time frame: post 6 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.