| Registry | NCT07862049 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, other |
| Enrollment | 40 (Estimated) |
| Sponsor | Northwell Health (Other) |
| Conditions | Inflammation, C-reactive Protein, Exercise Capacity |
| Interventions | Active Fruit Juice Intervention, Control Fruit Juice Intervention (Other) |
| Dates | start 2026-09-01 (estimated), primary completion 2028-09-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-10-07, last updated 2026-10-07 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Inflammation All trials for C-reactive Protein All trials of Active Fruit Juice Intervention All trials of Control Fruit Juice Intervention
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Active Fruit Juice Intervention | Experimental | Other: Active Fruit Juice Intervention | 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. |
| Control Fruit Juice Intervention | Active comparator | Other: Control Fruit Juice Intervention | 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. |
Sex: All, ages: 18 Years to 65 Years
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.| Facility | City | Country | Status |
|---|---|---|---|
| Nicholas Institute of Sports Medicine & Athletic Trauma (NISMAT) | New York, New York | United States | Recruiting |