BEET root juice to reverse functional impairment in PAD: The BEET PAD Trial
甜菜根汁逆转 PAD 功能损伤:甜菜 PAD 试验
基本信息
- 批准号:10440812
- 负责人:
- 金额:$ 73.98万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-07-01 至 2027-06-30
- 项目状态:未结题
- 来源:
- 关键词:AcuteArteriesBiogenesisBiologicalBiopsyBlood capillariesCell NucleusCharacteristicsChronicClinical TrialsConsumptionDisabled PersonsDoseDouble-Blind MethodElderlyEnvironmentFiberGastrocnemius MuscleHealthHourHypoxiaImpairmentIngestionIschemiaJuiceLower ExtremityMagnetic Resonance ImagingMeasuresMediatingMedicalMetabolicMitochondriaMuscleMuscle MitochondriaNOS3 geneNatural regenerationNitratesNitric OxideNitritesOralOutcomeOxidative StressOxygen ConsumptionParticipantPathway interactionsPerformancePerfusionPeripheral arterial diseasePersonsPhysical PerformancePhysical activityPlacebosPlant RootsPlasmaQuality of lifeQuestionnairesRandomizedRandomized Clinical TrialsReperfusion InjuryResearch PersonnelSkeletal MuscleSourceWalkingWorkactigraphyangiogenesisarterial spin labelingbrachial arteryconsumption measuresdensitydisabilityfollow-upfunctional declinefunctional disabilityimprovedinter-individual variationischemic injurymitochondrial dysfunctionpreclinical studypreventprimary outcomerandomized trialrepairedsatellite cell
项目摘要
BEETroot juice to reverse functional impairment in PAD: The BEET PAD Trial
Our work and that of others demonstrate that people with lower extremity peripheral artery disease (PAD)
have greater functional impairment, more rapid functional decline, and faster mobility loss than those without
PAD. In PAD, lower extremity ischemia during walking activity increases gastrocnemius (calf) muscle oxidative
stress, damages myofibers, and induces calf muscle mitochondrial dysfunction. Yet few medical therapies
improve functional impairment or prevent mobility loss in PAD.
Inorganic nitrate, abundant in beetroot juice, is a major source of nitric oxide (NO). In preclinical studies,
NO increases angiogenesis and perfusion, protects against ischemic injury, enhances mitochondrial activity,
and activates satellite cells, which restore and repair skeletal muscle. In three small pilot clinical trials,
including two by our co-investigator Dr. Jason Allen, oral nitrate or beetroot juice meaningfully improved
walking ability in people with PAD, compared to placebo. We propose a definitive multi-centered double-blind
randomized trial of beetroot juice vs. placebo in 210 people with PAD. We hypothesize that by increasing
lower extremity perfusion, calf muscle mitochondrial activity, and myofiber health and regeneration, beetroot
juice will improve walking performance in PAD. Our primary aim will determine whether, compared to placebo,
beetroot juice significantly improves six-minute walk at 4-month follow-up. In secondary aims, we will
distinguish acute from chronic effects of beetroot juice on six-minute walk and measure the effects of beetroot
juice on calf muscle perfusion, brachial artery flow-mediated dilation, physical activity (ActiGraph), the Walking
Impairment Questionnaire, and the short physical performance battery (SPPB).
Nitrate in beetroot juice is metabolized to nitrite and subsequently to NO, attaining peak nitrite levels 2.5
hours after ingestion. Inter-individual variability exists in the extent of metabolic conversion of nitrate to nitrite.
Therefore, in a secondary aim, among PAD participants randomized to beetroot juice, we will determine
whether those who attain a higher peak or a greater increase in plasma nitrite 2.5 hours after beetroot juice
consumption have greater increases in six-minute walk at 4-month follow-up, compared to those who attain a
lower peak or a smaller increase in plasma nitrite. We will also measure the durability of beetroot juice effects,
by repeating six-minute walk distance 7 and 14 days after the final dose of beetroot juice or placebo. We will
perform calf muscle biopsy at baseline and follow-up to study the effects of beetroot juice on muscle
mitochondrial biogenesis and activity, mitophagy, capillary characteristics, and myofiber health.
If beetroot juice improves functional performance and prevents functional decline in PAD, this widely
available and well tolerated therapy will have a major impact on preventing mobility loss and improving
quality of life in the large and growing number of people disabled by PAD.
甜菜根汁可以逆转PAD患者的功能损伤:甜菜PAD试验
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Mary McGrae McDermott其他文献
159 3D Submillimeter isotropic resolution superficial femoral artery wall MRI using SPACE at 3.0 T
- DOI:
10.1186/1532-429x-10-s1-a60 - 发表时间:
2008-10-22 - 期刊:
- 影响因子:
- 作者:
Zhuoli Zhang;Zhaoyang Fan;YiuCho Chung;Peter Weale;Timothy Carroll;Ioannis Koktzoglou;Renate Jerecic;James Carr;Mary McGrae McDermott;Debiao Li - 通讯作者:
Debiao Li
Changes in study design, gender issues, and other characteristics of clinical research published in three major medical journals from 1971 to 1991
- DOI:
10.1007/bf02599570 - 发表时间:
1995-01-01 - 期刊:
- 影响因子:4.200
- 作者:
Mary McGrae McDermott;Frank Lefevre;Joe Feinglass;Douglas Reifler;Nancy Dolan;Steven Potts;Kathleen Senger - 通讯作者:
Kathleen Senger
Building a research career in general internal medicine
- DOI:
10.1046/j.1525-1497.1998.00028.x - 发表时间:
1998-02-01 - 期刊:
- 影响因子:4.200
- 作者:
Marshall H. Chin;Kenneth E. Covinsky;Mary McGrae McDermott;Eric J. Thomas - 通讯作者:
Eric J. Thomas
Mary McGrae McDermott的其他文献
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{{ truncateString('Mary McGrae McDermott', 18)}}的其他基金
Far Red Light to Improve Functioning in PAD: the LIGHT PAD Trial
远红光改善 PAD 功能:LIGHT PAD 试验
- 批准号:
10572758 - 财政年份:2023
- 资助金额:
$ 73.98万 - 项目类别:
Response to Exercise and Nitric Oxide in PAD: the RESIST PAD Trial
PAD 对运动和一氧化氮的反应:RESIST PAD 试验
- 批准号:
10656845 - 财政年份:2023
- 资助金额:
$ 73.98万 - 项目类别:
ENhancing exercise with LIGHT to improve functioning in PAD: the ENLIGHTEN PAD Trial
利用 LIGHT 加强锻炼以改善 PAD 功能:ENLIGHTEN PAD 试验
- 批准号:
10645929 - 财政年份:2023
- 资助金额:
$ 73.98万 - 项目类别:
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD
PAD 运动的序贯多重评估随机试验:PAD 的 SMART 运动
- 批准号:
10708097 - 财政年份:2022
- 资助金额:
$ 73.98万 - 项目类别:
BEET root juice to reverse functional impairment in PAD: The BEET PAD Trial
甜菜根汁逆转 PAD 功能损伤:甜菜 PAD 试验
- 批准号:
10649671 - 财政年份:2022
- 资助金额:
$ 73.98万 - 项目类别:
FIsetin to Reduce Senescence and mobility impairmenT in PAD: the FIRST Pilot Randomized Trial
非瑟酮可减少 PAD 中的衰老和活动障碍:第一个试点随机试验
- 批准号:
10526851 - 财政年份:2022
- 资助金额:
$ 73.98万 - 项目类别:
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD
PAD 运动的序贯多重评估随机试验:PAD 的 SMART 运动
- 批准号:
10584209 - 财政年份:2022
- 资助金额:
$ 73.98万 - 项目类别:
COCOA flavanols to improve walking performance in PAD: the COCOA-PAD II Trial
可可黄烷醇可改善 PAD 的步行表现:COCOA-PAD II 试验
- 批准号:
10430199 - 财政年份:2021
- 资助金额:
$ 73.98万 - 项目类别:
COCOA flavanols to improve walking performance in PAD: the COCOA-PAD II Trial
可可黄烷醇可改善 PAD 的步行表现:COCOA-PAD II 试验
- 批准号:
10685352 - 财政年份:2021
- 资助金额:
$ 73.98万 - 项目类别:
COCOA flavanols to improve walking performance in PAD: the COCOA-PAD II Trial
可可黄烷醇可改善 PAD 的步行表现:COCOA-PAD II 试验
- 批准号:
10209585 - 财政年份:2021
- 资助金额:
$ 73.98万 - 项目类别:
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