Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07063173

Bioavailability of Ration Items Containing Tart Cherry Extract

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
United States Army Research Institute of Environmental Medicine · Federal
Sex
All
Age
17 Years – 39 Years
Healthy volunteers
Accepted

Summary

To determine how consuming food items containing shelf-stored tart cherry impacts your body's ability to absorb and use the compounds within tart cherry.

Detailed description

Consumption of tart cherry (TC) products may have beneficial effects on military performance. For example, in-vitro and in-vivo evidence indicates the benefits of TC products on muscle. This includes reduced muscle damage, muscle soreness and strength decrements after resistance exercise; and increased antioxidant capacity, reduced inflammation and reduced lipid peroxidation following endurance exercise. Prior to assessing potential performance benefits, DEVCOM-Soldier Center's Combat Feeding Division (CFD) is seeking to determine the effect of shelf-stable tart cherry powder (TCP)-containing food items on the bioavailability and absorption of polyphenols in humans. The primary objective of his study is to evaluate the postprandial concentrations of anthocyanins, anthocyanidins, flavonols, phenolic acids, and their degradation products in response to a TCP-containing, shelf-stable bar and shelf-stable powdered drink, compared to a non-TCP containing control item and a TC-containing commercial item. Secondary objectives are to determine postprandial polyphenol absorption via urine concentrations of anthocyanins, anthocyanidins, flavonols, phenolic acids and their degradation products; and circulating antioxidant capacity. Active-duty military personnel and civilians will be invited to participate in the study if they are between the ages of 18 (or 17 for military personnel) and 39, are willing to participate in all study procedures and comply with all study instruction and pass a general medical clearance. In this randomized, crossover study, participants will consume three different food products containing TC component and a control (food item without TC) over four different sessions. Each session will be followed by a five-day washout period. On the day of each experimental session, and after verification of compliance with study procedures (e.g., overnight fast and low polyphenol diet day prior…), an IV catheter will be inserted, and an initial blood sample will be collected. Immediately following, volunteers will consume either: 1) commercially available TC juice ("gold standard"), 2) CFD-formulated snack bar containing TCP, 3) CFD-formulated powdered drink containing TCP, or 4) CFD-formulated beverage containing no polyphenols (Figure 1). TC containing treatments will be matched by total anthocyanin content (\~120 mg total). Blood samples will be collected on the day of each session and the day after for measurement of circulating phenolic compounds (by CFD using LC-MS). Biomarkers of oxidation and anti-oxidation will also be measured, along with associations between study outcomes and gut microbiome composition. Complete data will be collected for up to 15 participants.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTFruit BarTart Cherry N185
DIETARY_SUPPLEMENTPowdered DrinkVita Cherry Sport N1244 (FutureCeuticals, Momence, IL)
DIETARY_SUPPLEMENTCommercially available 100% tart cherry juice100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)
DIETARY_SUPPLEMENTPlacebo beveragePlacebo beverage

Timeline

Start date
2024-06-14
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2025-07-14
Last updated
2025-12-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07063173. Inclusion in this directory is not an endorsement.