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Mediterranean diet, Metabolites, and Cardiovascular Disease

Award Number: R01HL118264
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/15/2013
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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Mediterranean diet, Metabolites, and Cardiovascular Disease - ABSTRACT Metabolomics technique holds promise for better understanding the role of diet in cardiovascular disease (CVD) epidemiology and prevention. In particular, a multi-fluid multi-metabolite approach combining urinary and plasma metabolomics will likely enhance the accuracy and precision of nutritional biomarkers, with strong potential to develop novel tools for dietary assessment in precision nutrition research. This competing renewal is aimed to examine the effects of the randomized Mediterranean diet (MedDiet) interventions on urinary metabolite levels and to assess dietary biomarkers' predictive ability for future CVD risk in the landmark PREDIMED trial. We will assess urinary metabolomics in relation to CVD through a case-cohort design, including a representative subcohort randomly sampled from all PREDIMED participants (10%, n=779), and incident CVD cases (including myocardial infarction (MI), stroke, heart failure, and cardiovascular deaths) through December 2017 (n=529). The proposed Specific Aims are: (1) To identify specific urinary metabolites and multi-metabolite signatures of the MedDiet pattern and its main food components; (2) To examine the effects of the randomized dietary interventions on changes in the urinary multi-metabolite signatures of the MedDiet pattern and its major food components from baseline to year 1 (post intervention); (3) To investigate whether baseline and 1-year changes in urinary multi-metabolite signatures of the MedDiet pattern and of individual foods are associated with subsequent risk of CVD; and (4) To develop a multi-fluid (urine and plasma) multi-metabolite signature that robustly predicts risk of CVD and assess whether 1-year changes in the signature mediate the effects of the dietary interventions on the composite CVD outcome. As a sub-aim, we will compare the predictive roles of plasma and urinary metabolites of the MedDiet pattern on CVD risk. This ongoing grant started in 2013 and was renewed in 2017. To date, 36 papers have been published or submitted (including 20 papers in the current grant cycle). The PREDIMED metabolomics data have been used as a resource for replicating metabolomics analyses of CVD outcomes in several US cohorts. This competing renewal application will extend our long-standing research on MedDiet and CVD to multi-fluid multi- metabolite profiling in a large randomized intervention trial. This project leverages numerous strengths of the PREDIMED trial, a multi-disciplinary and highly productive team, cutting-edge metabolomics technologies, and high-dimensional data analytics. The identified dietary biomarkers will enhance the quality and rigor of nutrition research and strengthen the evidence base for developing dietary recommendations and nutrition policies. The proposed work will facilitate the precision nutrition research agenda outlined in the 2020-2030 Strategic Plan for NIH Nutrition Research.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Cardiovascular Diseases Research	000	12	1/13/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $468,441 )
2025	2025	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Cardiovascular Diseases Research	002	12	9/19/2025	SUPPLEMENT FOR EXPANSION	$88,812
2025	2025	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	12	3/4/2025	NON-COMPETING CONTINUATION	$468,441
2025	2025	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Cardiovascular Diseases Research	003	12	9/19/2025	SUPPLEMENT FOR EXPANSION	$70,526
2025	2025	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	1033 MASSACHUSETTS AVE STE 3	CAMBRIDGE	MA	02138	MIDDLESEX	USA	Cardiovascular Diseases Research	001	12	9/19/2025	NON-COMPETING CONTINUATION	-$159,338
														Subtotal = $468,441

Issue Date FY: 2024 ( Subtotal = $521,672 )
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	11	2/26/2024	NON-COMPETING CONTINUATION	$479,088
2024	2024	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	001	11	6/21/2024	NON-COMPETING CONTINUATION	$42,584
														Subtotal = $521,672

Issue Date FY: 2023 ( Subtotal = $533,776 )
2023	2023	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	10	4/7/2023	NON-COMPETING CONTINUATION	$533,776
														Subtotal = $533,776

Issue Date FY: 2022 ( Subtotal = $572,249 )
2022	2022	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	001	9	1/15/2022	COMPETING CONTINUATION	$572,249
2022	2022	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	003	9	8/11/2022	COMPETING CONTINUATION	$20,636
2022	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	8	1/7/2022	NON-COMPETING CONTINUATION	$0
2022	2020	HARVARD COLLEGE PRESIDENT & FELLOWS OF	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	002	8	8/11/2022	NON-COMPETING CONTINUATION	-$20,636
														Subtotal = $572,249

Issue Date FY: 2020 ( Subtotal = $552,958 )
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	8	6/24/2020	NON-COMPETING CONTINUATION	$552,958
														Subtotal = $552,958

Issue Date FY: 2019 ( Subtotal = $571,826 )
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	7	6/23/2019	NON-COMPETING CONTINUATION	$555,876
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Minority Health and Health Disparities Research	001	7	7/3/2019	SUPPLEMENT FOR EXPANSION	$15,950
														Subtotal = $571,826

Issue Date FY: 2018 ( Subtotal = $560,097 )
2018	2018	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	004	6	7/13/2018	NON-COMPETING CONTINUATION	$560,097
2018	2017	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	003	5	1/19/2018	COMPETING CONTINUATION	$357,364
2018	2016	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	002	4	1/19/2018	EXTENSION WITH OR WITHOUT FUNDS	-$357,364
2018	2016	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	001	4	1/19/2018	EXTENSION WITH OR WITHOUT FUNDS	$11,062
2018	2015	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	3	1/19/2018	NON-COMPETING CONTINUATION	-$11,062
														Subtotal = $560,097

Issue Date FY: 2017 ( Subtotal = $592,401 )
2017	2017	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	003	5	8/17/2017	COMPETING CONTINUATION	$592,401
2017	2016	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	001	4	11/2/2016	EXTENSION WITH OR WITHOUT FUNDS	$326,955
2017	2016	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	002	4	8/17/2017	EXTENSION WITH OR WITHOUT FUNDS	$0
2017	2015	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	677 HUNTINGTON AVE	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	3	11/2/2016	NON-COMPETING CONTINUATION	-$326,955
														Subtotal = $592,401

Issue Date FY: 2016 ( Subtotal = $595,706 )
2016	2016	HARVARD UNIVERSITY, SCHOOL OF PUBLIC HEALTH	55 SHATTUCK STREET	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	4	6/22/2016	EXTENSION WITH OR WITHOUT FUNDS	$595,706
														Subtotal = $595,706

Issue Date FY: 2015 ( Subtotal = $616,064 )
2015	2015	HARVARD UNIVERSITY, SCHOOL OF PUBLIC HEALTH	55 SHATTUCK STREET	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	3	6/15/2015	NON-COMPETING CONTINUATION	$616,064
														Subtotal = $616,064

Issue Date FY: 2014 ( Subtotal = $611,127 )
2014	2014	HARVARD UNIVERSITY, SCHOOL OF PUBLIC HEALTH	55 SHATTUCK STREET	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	2	6/13/2014	NON-COMPETING CONTINUATION	$611,127
														Subtotal = $611,127

Issue Date FY: 2013 ( Subtotal = $645,995 )
2013	2013	HARVARD UNIVERSITY, SCHOOL OF PUBLIC HEALTH	55 SHATTUCK STREET	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	1	7/11/2013	NEW	$645,995
														Subtotal = $645,995

Grand Total All Awards = $6,842,312

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Mediterranean diet, Metabolites, and Cardiovascular Disease

Award Number: R01HL118264

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/15/2013

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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