Increased fruit juice for better exercise ability and lower inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, parallel-group study, adults with mildly elevated inflammation will be assigned to two fruit juice interventions to see how they affect C-reactive protein levels and exercise capacity. About 40 participants will be randomized to either the active juice or a control juice and will consume 2 x 8 oz servings daily for roughly two weeks. Inflammatory biomarkers and physical performance will be measured before and after the intervention to compare groups. The trial aims to understand if increased fruit juice intake can modulate inflammation and functional performance in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants ages 18-65 years old
2. Physically and cognitively able to provide informed consent.
3. Asymptomatic.
4. Prior confirmed high normal or mild elevation of CRP (1.5- 9.9 mg/L)
5. Able to perform a 30-second sit-to-stand test, a 6-minute walk test and a test of grip strength.
6. Amenable to finger stick blood collection to determine CRP.
7. Willing to consume 2- 8 oz juice beverages per day, containing 25 grams of sugar each, for 2 weeks.

Exclusion Criteria:

1. Diagnosis of:

   1. Obstructive coronary artery disease (CAD).
   2. Currently or recently having exertional chest pain or pressure with high-risk history of CAD.
   3. History of heart failure.
   4. Obstructive or restrictive lung disease.
   5. Rheumatoid disorders that may increase CRP (lupus, RA or other rheumatic disorder).
   6. Thromboembolic disease requiring anticoagulation.
   7. Type 1 and insulin-dependent diabetes.
   8. Irritable bowel syndrome or Crohn's disease.
   9. Uncontrolled or untreated Type 2 Diabetes
2. Participant is required to be on a stable dose of their maintenance medications for at least 1 month prior to participation in the study.
3. Requiring oxygen supplementation during awake hours.
4. Pregnancy or planning pregnancy during the duration of the study.
5. Breastfeeding women.
6. Score of 4 on any question in the DePaul Symptom Questionnaire - Post Exertional Malaise (DSQ-PEM).
7. Participant, who in the medical opinion of the investigator team, is unsuitable to participate.
8. Known allergy to apples or cherries.
9. Current use of non-steroidal anti-inflammatory drugs (NSAIDs) listed below but not limited to:

   1. Aspirin
   2. Ibuprofen (Advil, Motrin)
   3. Naproxen (Aleve, Naprosyn)
   4. Ketoprofen (Orudis)
   5. Meclofenamate (Ponstel)
10. The following steroids are excluded, but not limited to:

    1. Prednisolone
    2. Methylprednisolone
    3. Hydrocortisone
    4. Dexamethasme.
    5. Triamnicolone acetonide
    6. Budesonide
11. 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.

Where it's running

• Nicholas Institute of Sports Medicine & Athletic Trauma (NISMAT)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Christopher Tanayan, MD — Northwell Health
• Study coordinator: Beth Glace, MS
• Email: bglace@northwell.edu
• Phone: (212) 434-2717

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.