What is the Effect of Increased Consumption of Fruit Juice on Exercise Capacity and Inflammatory Biomarkers?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNorthwell Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Active Fruit Juice Intervention
Other interventionCommercially 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 Intervention
Other interventionCommercially 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active Fruit Juice InterventionExperimental treatment 1 intervention
Group B: Control Fruit Juice InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)Secondary outcomes
1
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.
Time frame
Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)2
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.
Time frame
Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)3
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).
Time frame
Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)4
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.
Time frame
Baseline to post-intervention assessment (approx. 2-3 weeks after enrollment)Sponsors and contacts
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Source ClinicalTrials.gov