NCT07862049 · Northwell Health
What is the Effect of Increased Consumption of Fruit Juice on Exercise Capacity and Inflammatory Biomarkers?
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Active Fruit Juice Intervention
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.
OTHER
Control Fruit Juice Intervention
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.
Primary outcome measures
Changes in the biomarker C-reactive protein (CRP) level
Time frame: Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
- 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:
- 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
- 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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2026 · Source of record for eligibility and locations