InflammationNCT07862049
What is the Effect of Increased Consumption of Fruit Juice on Exercise Capacity and Inflammatory Biomarkers?
A study testing Active Fruit Juice Intervention in people with Inflammation and C-reactive Protein, run by Northwell Health at 1 site in United States.
Trial summary
Dietary patterns and physical inactivity common in Western societies have been associated with chronic low-grade inflammation and an increased risk of non-communicable health conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammation, C-reactive Protein, Exercise Capacity
- What is being tested?
- Active Fruit Juice Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants ages 18-65 years old
- Physically and cognitively able to provide informed consent.
- Asymptomatic.
- Prior confirmed high normal or mild elevation of CRP (1.5- 9.9 mg/L)
- Able to perform a 30-second sit-to-stand test, a 6-minute walk test and a test of grip strength.
- Amenable to finger stick blood collection to determine CRP.
- Willing to consume 2- 8 oz juice beverages per day, containing 25 grams of sugar each, for 2 weeks.
Who cannot join
- Diagnosis of:
- Obstructive coronary artery disease (CAD).
- Currently or recently having exertional chest pain or pressure with high-risk history of CAD.
- History of heart failure.
- Obstructive or restrictive lung disease.
- Rheumatoid disorders that may increase CRP (lupus, RA or other rheumatic disorder).
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- Thromboembolic disease requiring anticoagulation.
- Type 1 and insulin-dependent diabetes.
- Irritable bowel syndrome or Crohn's disease.
- Uncontrolled or untreated Type 2 Diabetes
- Participant is required to be on a stable dose of their maintenance medications for at least 1 month prior to participation in the study.
- Requiring oxygen supplementation during awake hours.
- Pregnancy or planning pregnancy during the duration of the study.
- Breastfeeding women.
- Score of 4 on any question in the DePaul Symptom Questionnaire - Post Exertional Malaise (DSQ-PEM).
- Participant, who in the medical opinion of the investigator team, is unsuitable to participate.
- Known allergy to apples or cherries.
- Current use of non-steroidal anti-inflammatory drugs (NSAIDs) listed below but not limited to:
- Aspirin
- Ibuprofen (Advil, Motrin)
- Naproxen (Aleve, Naprosyn)
- Ketoprofen (Orudis)
- Meclofenamate (Ponstel)
- The following steroids are excluded, but not limited to:
- Prednisolone
- Methylprednisolone
- Hydrocortisone
- Dexamethasme.
- Triamnicolone acetonide
- Budesonide
- Participants who have Limited English Proficiency (LEP) are excluded because study team members are not fluent in languages other than English, and the protocol relies heavily on direct verbal communication with participants throughout the study period. The protocol also involves detailed instructions, questionnaires and symptom reporting that require clear comprehension to ensure valid data collection and participant safety. Without certified translations, interpreter services and validated non-English study instruments, there is a risk that participants may not fully understand study procedures, potential risks or their rights as research participants. This could compromise informed consent, increase the likelihood of protocol deviations and place participants at undue risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nicholas Institute of Sports Medicine & Athletic Trauma (NISMAT)
New York, New York, 10065
Ashley Giannita, BS, CCRC, 212-434-2744, agiannita@northwell.edu
About this study
Dietary patterns and physical inactivity common in Western societies have been associated with chronic low-grade inflammation and an increased risk of non-communicable health conditions. Fruits and vegetables contain polyphenols and other bioactive compounds that may have antioxidant and anti-inflammatory properties and may influence inflammatory biomarkers.
This study will evaluate the effects of increased consumption of a fruit juice on inflammatory biomarkers and exercise capacity in adults with mildly elevated inflammation. Approximately 40 participants will be randomly assigned to consume one of two fruit juice interventions daily for approximately 2 weeks. Changes in C-reactive protein (CRP) and exercise capacity, assessed using a 6-minute walk test, will be evaluated before and after the intervention and compared between the two groups.
Read the detailed description
Industrialization and changes in dietary and physical activity patterns have contributed to differences in the health conditions experienced by populations in Western societies. Chronic, non-communicable conditions, many of which are associated with low-grade inflammation, are now major contributors to morbidity and mortality. Dietary patterns characterized by high consumption of refined carbohydrates, sugars, salt, and animal fats and relatively low consumption of fruits, vegetables, fiber, and plant-derived phytochemicals may contribute to an inflammatory state. Similarly, low levels of physical activity have been associated with increased inflammation and elevated inflammatory biomarkers such as C-reactive protein (CRP).
Fruits and vegetables provide fiber, vitamins, minerals, and bioactive compounds including polyphenols. Polyphenols are plant-derived compounds with antioxidant and anti-inflammatory properties that may influence inflammatory processes and other physiological pathways. Increasing consumption of minimally processed plant foods and fruit-derived products may therefore represent a potential approach for increasing intake of these bioactive compounds and examining their relationship with markers of inflammation and physical performance.
This randomized, parallel-group interventional study will evaluate the effects of two fruit juice interventions on inflammatory biomarkers and exercise capacity in adults with mildly elevated inflammation. Approximately 40 adult participants will be enrolled and randomly assigned to one of two intervention groups. Participants will consume their assigned fruit juice daily for approximately 2 weeks.
At baseline, participants will undergo study assessments including measurement of inflammatory status using a finger-stick blood sample for C-reactive protein (CRP) and assessment of exercise capacity using a standardized 6-minute walk test. Participants will then consume their assigned intervention daily during the study period. Follow-up assessments will be performed after the intervention period to evaluate changes in CRP and exercise capacity.
The primary objective of the study is to evaluate whether daily consumption of a fruit juice intervention is associated with changes in inflammatory biomarkers and exercise capacity in adults with mildly elevated inflammation. Changes in CRP and performance on the 6-minute walk test will be assessed before and after the intervention and compared between the two intervention groups.
The study is investigator-initiated and involves commercially available fruit juice products. The study is not conducted under an Investigational New Drug (IND) application or Investigational Device Exemption (IDE). The study has been reviewed and approved by the Northwell Institutional Review Board.
- Conditions
- Inflammation, C-reactive Protein, Exercise Capacity
- Being tested
- Active Fruit Juice Intervention, Control Fruit Juice Intervention
- Keywords
- Inflammation, C-reactive protein, Inflammatory Biomarkers, Dietary Intervention, Exercise capacity, Fruit Juice Consumption
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Fruit Juice InterventionOther
Commercially available fruit juice administered as the dietary intervention. Participants will consume the assigned juice daily for approximately 2 weeks according to the study protocol. The specific product identity is not disclosed to participants as part of the study design.
Control Fruit Juice InterventionOther
Commercially available fruit juice administered as the investigational dietary intervention. Participants will consume the assigned juice daily for approximately 2 weeks according to the study protocol. The specific product identity is not disclosed to participants as part of the study design.
| Study group | Role | What they receive |
|---|---|---|
| Active Fruit Juice Intervention | Experimental | Participants assigned to this arm will consume the fruit juice intervention daily for approximately 2 weeks. The intervention is a commercially available fruit juice that can be purchased by consumers through retail and other commercial sources. The intervention is not an investigational drug or medical device. Receives: Other: Active Fruit Juice Intervention |
| Control Fruit Juice Intervention | Active comparator | Participants assigned to this arm will consume the control fruit juice intervention daily for approximately 2 weeks. The intervention is a commercially available fruit juice that can be purchased by consumers through retail and other commercial sources. The intervention is not an investigational drug or medical device. Receives: Other: Control Fruit Juice Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the biomarker C-reactive protein (CRP) level
Change in C-reactive protein (CRP) level, measured in mg/L, from baseline to the post-intervention assessment following approximately 2 weeks of daily fruit juice consumption
Measured: Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)
Secondary outcomes (4)
Change in 6-Minute Walk Test Distance
Change in distance (m) walked during the 6-minute walk test from baseline to the post-intervention assessment following approximately 2 weeks of daily fruit juice consumption.
Measured: Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)
Change in Hand Grip Strength
Change in hand grip strength (kg) from baseline to the post-intervention assessment following approximately 2 weeks of daily fruit juice consumption. Hand grip strength is measured using a hand dynamometer.
Measured: Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)
Change in Grip Endurance
Change in grip endurance from baseline to the post-intervention assessment following approximately 2 weeks of daily fruit juice consumption. Grip endurance will be assessed at 50% of the mean maximal contraction force (min).
Measured: Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)
Change in Sit-to-Stand Test Performance
Change in number of repetitions from baseline to the post-intervention assessment following approximately 2 weeks of daily fruit juice consumption.
Measured: Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Tanayan, Northwell Health
- Investigators
- Christopher Tanayan, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862049
- Sponsor's protocol ID
- 25-1136
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because there are no current plans to make the study data available for secondary research.
Publications
Wang DD, Li Y, Bhupathiraju SN, Rosner BA, Sun Q, Giovannucci EL, Rimm EB, Manson JE, Willett WC, Stampfer MJ, Hu FB. Fruit and Vegetable Intake and Mortality: Results From 2 Prospective Cohort Studies of US Men and Women and a Meta-Analysis of 26 Cohort Studies. Circulation. 2021 Apr 27;143(17):1642-1654. doi: 10.1161/CIRCULATIONAHA.120.048996. Epub 2021 Mar 1.
PubMed 3364134325. Ataie-Jafari A, Hosseini S, Karimi F, Pajouhi M. Effects of sour cherry juice on blood glucose and some cardiovascular risk factors improvements in diabetic women: A pilot study. Nutr Food Sci. 2008;38(4):355-360. doi:10.1108/00346650810891414
He YH, Xiao C, Wang YS, Zhao LH, Zhao HY, Tong Y, Zhou J, Jia HW, Lu C, Li XM, Lu AP. [Antioxidant and anti-inflammatory effects of cyanidin from cherries on rat adjuvant-induced arthritis]. Zhongguo Zhong Yao Za Zhi. 2005 Oct;30(20):1602-5. Chinese.
PubMed 1642254323. Soong K. USWNT soccer players recover with tart cherry juice. Does it work? The Washington Post. https://www.washingtonpost.com/wellness/2023/08/04/cherry-juice-athletic-performance-sleep-science/. August 4, 2023. Accessed August 15, 2025.
Bell PG, McHugh MP, Stevenson E, Howatson G. The role of cherries in exercise and health. Scand J Med Sci Sports. 2014 Jun;24(3):477-90. doi: 10.1111/sms.12085. Epub 2013 May 27.
PubMed 23710994Howatson G, McHugh MP, Hill JA, Brouner J, Jewell AP, van Someren KA, Shave RE, Howatson SA. Influence of tart cherry juice on indices of recovery following marathon running. Scand J Med Sci Sports. 2010 Dec;20(6):843-52. doi: 10.1111/j.1600-0838.2009.01005.x.
PubMed 19883392Schumacher HR, Pullman-Mooar S, Gupta SR, Dinnella JE, Kim R, McHugh MP. Randomized double-blind crossover study of the efficacy of a tart cherry juice blend in treatment of osteoarthritis (OA) of the knee. Osteoarthritis Cartilage. 2013 Aug;21(8):1035-41. doi: 10.1016/j.joca.2013.05.009. Epub 2013 May 31.
PubMed 23727631Kelley DS, Adkins Y, Reddy A, Woodhouse LR, Mackey BE, Erickson KL. Sweet bing cherries lower circulating concentrations of markers for chronic inflammatory diseases in healthy humans. J Nutr. 2013 Mar;143(3):340-4. doi: 10.3945/jn.112.171371. Epub 2013 Jan 23.
PubMed 23343675Chai SC, Davis K, Zhang Z, Zha L, Kirschner KF. Effects of Tart Cherry Juice on Biomarkers of Inflammation and Oxidative Stress in Older Adults. Nutrients. 2019 Jan 22;11(2):228. doi: 10.3390/nu11020228.
PubMed 30678193Gholami A, Amirkalali B, Baradaran HR, Hariri M. The beneficial effect of tart cherry on plasma levels of inflammatory mediators (not recovery after exercise): A systematic review and meta-analysis on randomized clinical trials. Complement Ther Med. 2022 Sep;68:102842. doi: 10.1016/j.ctim.2022.102842. Epub 2022 May 30.
PubMed 3565396616. Bhagwat S, Haytowitz DB. USDA Database for the Flavonoid Content of Selected Foods, Release 3.3 (March 2018). USDA Database for the Flavonoid Content of Selected Foods, Release 3.3 (March 2018). Accessed July 18, 2024. https://agdatacommons.nal.usda.gov/articles/dataset/USDA_Database_for_the_Flavonoid_Content_of_Selected_Foods_Release_3_1_May_2014_/24659802
Furman D, Campisi J, Verdin E, Carrera-Bastos P, Targ S, Franceschi C, Ferrucci L, Gilroy DW, Fasano A, Miller GW, Miller AH, Mantovani A, Weyand CM, Barzilai N, Goronzy JJ, Rando TA, Effros RB, Lucia A, Kleinstreuer N, Slavich GM. Chronic inflammation in the etiology of disease across the life span. Nat Med. 2019 Dec;25(12):1822-1832. doi: 10.1038/s41591-019-0675-0. Epub 2019 Dec 5.
PubMed 31806905Booth FW, Roberts CK, Laye MJ. Lack of exercise is a major cause of chronic diseases. Compr Physiol. 2012 Apr;2(2):1143-211. doi: 10.1002/cphy.c110025.
PubMed 23798298Silveira EA, Mendonca CR, Delpino FM, Elias Souza GV, Pereira de Souza Rosa L, de Oliveira C, Noll M. Sedentary behavior, physical inactivity, abdominal obesity and obesity in adults and older adults: A systematic review and meta-analysis. Clin Nutr ESPEN. 2022 Aug;50:63-73. doi: 10.1016/j.clnesp.2022.06.001. Epub 2022 Jun 14.
PubMed 35871953Fiuza-Luces C, Santos-Lozano A, Joyner M, Carrera-Bastos P, Picazo O, Zugaza JL, Izquierdo M, Ruilope LM, Lucia A. Exercise benefits in cardiovascular disease: beyond attenuation of traditional risk factors. Nat Rev Cardiol. 2018 Dec;15(12):731-743. doi: 10.1038/s41569-018-0065-1.
PubMed 30115967