💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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