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
2 other identifiers
interventional
158
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Oct 2011
Longer than P75 for not_applicable hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 6, 2017
CompletedFirst Posted
Study publicly available on registry
December 12, 2017
CompletedDecember 12, 2017
December 1, 2017
3.8 years
December 6, 2017
December 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Systolic blood pressure (SBP)
SBP reduction in mmHg
post 6 weeks intervention
Secondary Outcomes (5)
Diastolic blood pressure (DBP)
post 6 weeks intervention
low density lipoprotein cholesterol (LDL)
post 6 weeks intervention
high density lipoprotein cholesterol (HDL)
post 6 weeks intervention
triglycerides (TG)
post 6 weeks intervention
total cholesterol
post 6 weeks intervention
Study Arms (4)
Baseline
PLACEBO COMPARATORBaseline corresponds to typical American diet
PROT rich diet
ACTIVE COMPARATORProtein rich diet for 6 weeks
MUFA rich diet
ACTIVE COMPARATORMUFA rich diet for 6 weeks
CARB rich diet
ACTIVE COMPARATORCARB rich diet for 6 weeks
Interventions
Consumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
Consumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
Consumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- CVD or diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29506183DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2017
First Posted
December 12, 2017
Study Start
October 1, 2011
Primary Completion
July 31, 2015
Study Completion
December 1, 2017
Last Updated
December 12, 2017
Record last verified: 2017-12