BioavailabilityTart CherryNCT07063173
Bioavailability of Ration Items Containing Tart Cherry Extract
A study testing Fruit Bar, Powdered Drink and Commercially available 100% tart cherry juice in people with Bioavailability, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Fruit Bar, Powdered Drink and Commercially available 100% tart cherry juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
- In good health as determined by OMSO (Office of Medical Support and Oversight).
- Supervisor approval for federal civilian employees and non-HRV active-duty military personnel stationed at NSSC
Who cannot join
- • Unable to understand verbal or written instructions or testing materials in English.
- Have a bleeding disorder (e.g., von Willebrand Disease, hemophilia) or are being treated with medication that will impair blood clotting (for example, coumadin)
- Have a history of GI-related conditions that may impact macronutrient absorption (e.g., Crohn's disease, ulcerative colitis, Celiac's disease or gluten sensitivity, bariatric surgery or gastroparesis, short bowel, inflammatory bowel disease, etc…);
- Any use of antibiotics or antifungal, except topical antibiotics/antifungals within 3 months of study participation.
- Colonoscopy within 3 months of study participation.
- Regular (i.e., weekly or more frequent) use of over-the-counter medications (including antacids, laxatives, stool softeners, and antidiarrheals) unless approved by OMSO and study PI.
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- Are habitually taking nonsteroidal anti-inflammatory drugs (e.g., Advil, aspirin), corticosteroids (e.g., prednisone) or immunosuppressants (e.g. Humira);
- Have an allergy or aversion (extreme dislike) to any of the test foods(e.g., cherry flavored beverages or bar). Allergy symptoms may include anaphylaxis, hives or eczema, tingling/itching in the mouth, dizziness or fainting, diarrhea, nausea or vomiting, swelling of the lips, face, tongue and throat).
- Have donated blood within the past 8 weeks of the first test session or plan to donate blood during the study.
- Are not willing to abstain from tobacco products and vigorous exercise for at least 24 hours" before each trial and consume a low-polyphenol diet two days prior to each test session and on the day of the test session.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert Roussel, PhD contact
United States1 site, 1 recruiting
- Recruiting
USARIEM
Natick, Massachusetts, 01760
Tracey J Smith, PhD, 508-206-2390 ext. 2390, treacey.smith10.civ@health.mil
About this study
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.
Read the 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
- Bioavailability
- Being tested
- Fruit Bar, Powdered Drink, Commercially available 100% tart cherry juice, Placebo beverage
- Keywords
- military, tart cherry, muscle recovery, polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit BarDietary supplement
Also called Tart Cherry N185
Tart Cherry N185
Powdered DrinkDietary supplement
Also called Vita Cherry Sport N1244
Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)
Commercially available 100% tart cherry juiceDietary supplement
Also called "gold standard" beverage
100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)
Placebo beverageDietary supplement
Placebo beverage
| Study group | Role | What they receive |
|---|---|---|
| Tart Cherry Juice | Active comparator | 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. Receives: Dietary Supplement: Fruit Bar; Dietary Supplement: Powdered Drink; Dietary Supplement: Placebo beverage |
| Fruit Bar | Active comparator | The fruit powder is incorporated into a snack bar, which delivers ~120 mg of anthocyanins. Receives: Dietary Supplement: Powdered Drink; Dietary Supplement: Commercially available 100% tart cherry juice; Dietary Supplement: Placebo beverage |
| Powdered Drink | Active comparator | The fruit powder is incorporated into a powdered drink, which delivers ~120 mg of anthocyanins.. Receives: Dietary Supplement: Fruit Bar; Dietary Supplement: Commercially available 100% tart cherry juice; Dietary Supplement: Placebo beverage |
| Control Beverage | Placebo comparator | A control powdered drink will be formulated with similar organoleptic qualities to the TCP-containing powdered drink without containing any polyphenol-rich ingredients. Receives: Dietary Supplement: Fruit Bar; Dietary Supplement: Powdered Drink; Dietary Supplement: Commercially available 100% tart cherry juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and postprandially @ 30-minutes, 60-minutes, 120-minutes, 240-minutes, 360-mins, 24 hours
Secondary outcomes (1)
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
Measured: Baseline and postprandially @ Baseline and postprandially @ 30-minutes, 60-minutes, 120-minutes, 240-minutes, 360-mins, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start14 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Tracey Smith, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063173
- Sponsor's protocol ID
- 24-07
- Acronym
- Tart Cherry
- Status last verified
- Dec 2025
- First submitted
- 17 Mar 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Ration Items Containing Tart Cherry Extract
- ClinicalTrials.gov ID
- NCT07063173
- Acronym / sponsor ID
- Tart Cherry / 24-07
- Conditions
- Bioavailability
- Keywords
- military, tart cherry, muscle recovery, polyphenols
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tart Cherry Juice | Active comparator | Dietary Supplement: Fruit Bar, Dietary Supplement: Powdered Drink, Dietary Supplement: Placebo beverageThe 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. |
| Fruit Bar | Active comparator | Dietary Supplement: Powdered Drink, Dietary Supplement: Commercially available 100% tart cherry juice, Dietary Supplement: Placebo beverageThe fruit powder is incorporated into a snack bar, which delivers ~120 mg of anthocyanins. |
| Powdered Drink | Active comparator | Dietary Supplement: Fruit Bar, Dietary Supplement: Commercially available 100% tart cherry juice, Dietary Supplement: Placebo beverageThe fruit powder is incorporated into a powdered drink, which delivers ~120 mg of anthocyanins.. |
| Control Beverage | Placebo comparator | Dietary Supplement: Fruit Bar, Dietary Supplement: Powdered Drink, Dietary Supplement: Commercially available 100% tart cherry juiceA control powdered drink will be formulated with similar organoleptic qualities to the TCP-containing powdered drink without containing any polyphenol-rich ingredients. |
Who may qualify
- Ages
- 17 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Active duty military personnel and civilians will be invited to participate in the study if they:
Key exclusion criteria (10 listed)
- • Unable to understand verbal or written instructions or testing materials in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit BarAlso: Tart Cherry N185Tart Cherry N185 | Dietary supplement | Control Beverage, Powdered Drink, Tart Cherry Juice |
| Powdered DrinkAlso: Vita Cherry Sport N1244Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL) | Dietary supplement | Control Beverage, Fruit Bar, Tart Cherry Juice |
| Commercially available 100% tart cherry juiceAlso: "gold standard" beverage100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK) | Dietary supplement | Control Beverage, Fruit Bar, Powdered Drink |
| Placebo beveragePlacebo beverage | Dietary supplement | Fruit Bar, Powdered Drink, Tart Cherry Juice |
Primary outcome
Postprandial concentrations of polyphenols in plasma
Time frame: Baseline and postprandially @ 30-minutes, 60-minutes, 120-minutes, 240-minutes, 360-mins, 24 hours
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).
1 secondary outcome
Postprandial concentrations of polyphenols in urine
Time frame: Baseline and postprandially @ Baseline and postprandially @ 30-minutes, 60-minutes, 120-minutes, 240-minutes, 360-mins, 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Roussel, PhD contact
Tracey Smith, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit Bar, Powdered Drink and Commercially available 100% tart cherry juice in people with Bioavailability, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracey J Smith, PhD (5082062390 ext. 2390, tracey.smith10.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial concentrations of polyphenols in plasma (time frame: Baseline and postprandially @ 30-minutes, 60-minutes, 120-minutes, 240-minutes, 360-mins, 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.