An interventional study of Fruit Bar and Powdered Drink in Bioavailability, sponsored by United States Army Research Institute of Environmental Medicine. Recruiting at 1 site in United States. Open to participants aged 17 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by United States Army Research Institute of Environmental Medicine · Not applicable, Interventional, and Other
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.
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.
Active duty military personnel and civilians will be invited to participate in the study if they:
Exclusion Criteria:
Unable to understand verbal or written instructions or testing materials in English.
The commercially available tart cherry (TC) drink contains 100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK) as a "gold standard". Participants will consume 60 mL of the concentrate diluted with 500 mL of water, which delivers \~120 mg of anthocyanins.
Dietary Supplement: Fruit Bar · Dietary Supplement: Powdered Drink · Dietary Supplement: Placebo beverage
The fruit powder is incorporated into a snack bar, which delivers \~120 mg of anthocyanins.
Dietary Supplement: Powdered Drink · Dietary Supplement: Commercially available 100% tart cherry juice · Dietary Supplement: Placebo beverage
The fruit powder is incorporated into a powdered drink, which delivers \~120 mg of anthocyanins..
Dietary Supplement: Fruit Bar · Dietary Supplement: Commercially available 100% tart cherry juice · Dietary Supplement: Placebo beverage
A control powdered drink will be formulated with similar organoleptic qualities to the TCP-containing powdered drink without containing any polyphenol-rich ingredients.
Dietary Supplement: Fruit Bar · Dietary Supplement: Powdered Drink · Dietary Supplement: Commercially available 100% tart cherry juice
Tart Cherry N185
Also known as: Tart Cherry N185
Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)
Also known as: Vita Cherry Sport N1244
100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)
Also known as: "gold standard" beverage
Placebo beverage
Postprandial concentrations of polyphenols in plasma
The primary objective of this study is to evaluate the postprandial concentrations of: * nmol/L for anthocyanins \& anthocyanidins (cyanidin-3-glucosylrutinoside, cyanidin-3-rutinoside,cyanidin-3-sophoroside, cyanidin-3-glucoside, cyanidin, peonidin-3-glucoside and pelargonidin); * µmol/L for flavonols (Isorhamnetin-3-rutinoside, kaemperol, and que after consuming a TCP-containing, shelf-stable bar and shelf-stable powdered drink (compared to a non-TCP containing control and a TC-containing commercial item).
Time frame: Baseline and postprandially @ 30-minutes, 60-minutes, 120-minutes, 240-minutes, 360-mins, 24 hours
Postprandial concentrations of polyphenols in urine
Secondary objectives are to determine postprandial polyphenol absorption via urine concentrations of anthocyanins, anthocyanidins, flavonols, phenolic acids and their degradation products as well as circulating antioxidant capacity; and to determine associations between these outcomes and gut microbiome composition
Time frame: Baseline and postprandially @ Baseline and postprandially @ 30-minutes, 60-minutes, 120-minutes, 240-minutes, 360-mins, 24 hours
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Plan to share: No — The principal investigator, with the assistance of associate investigators and project coordinator, will continuously evaluate recruitment, the informed consent process, adverse events, and protocol adherence and deviations in order to identify unanticipated problems or risks to the participants associated with the research. The principal investigator will ensure that the number of participants recruited for this study complies with the protocol. The principal investigator will be responsible for continually monitoring that data for each participant is collected and analyzed as specified in this protocol, and for ensuring that study files and IRB documentation are appropriate and up to date. The principal investigator and OMSO staff will discuss "discontinuation criteria" for individual participants as the study progresses, based on their observations of the participant during testing or non-testing periods.
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United States Army Research Institute of Environmental Medicine