Bioavailability of Ration Items Containing Tart Cherry Extract

NCT ID: NCT07063173

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-14

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Bioavailability

Keywords

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military tart cherry muscle recovery polyphenols

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

One of four test food items will be consumed on the morning of each test trial (randomly assigned).

Study Groups

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Tart Cherry Juice

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.

Group Type ACTIVE_COMPARATOR

Fruit Bar

Intervention Type DIETARY_SUPPLEMENT

Tart Cherry N185

Powdered Drink

Intervention Type DIETARY_SUPPLEMENT

Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)

Placebo beverage

Intervention Type DIETARY_SUPPLEMENT

Placebo beverage

Fruit Bar

The fruit powder is incorporated into a snack bar, which delivers \~120 mg of anthocyanins.

Group Type ACTIVE_COMPARATOR

Powdered Drink

Intervention Type DIETARY_SUPPLEMENT

Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)

Commercially available 100% tart cherry juice

Intervention Type DIETARY_SUPPLEMENT

100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)

Placebo beverage

Intervention Type DIETARY_SUPPLEMENT

Placebo beverage

Powdered Drink

The fruit powder is incorporated into a powdered drink, which delivers \~120 mg of anthocyanins..

Group Type ACTIVE_COMPARATOR

Fruit Bar

Intervention Type DIETARY_SUPPLEMENT

Tart Cherry N185

Commercially available 100% tart cherry juice

Intervention Type DIETARY_SUPPLEMENT

100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)

Placebo beverage

Intervention Type DIETARY_SUPPLEMENT

Placebo beverage

Control Beverage

A control powdered drink will be formulated with similar organoleptic qualities to the TCP-containing powdered drink without containing any polyphenol-rich ingredients.

Group Type PLACEBO_COMPARATOR

Fruit Bar

Intervention Type DIETARY_SUPPLEMENT

Tart Cherry N185

Powdered Drink

Intervention Type DIETARY_SUPPLEMENT

Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)

Commercially available 100% tart cherry juice

Intervention Type DIETARY_SUPPLEMENT

100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)

Interventions

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Fruit Bar

Tart Cherry N185

Intervention Type DIETARY_SUPPLEMENT

Powdered Drink

Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)

Intervention Type DIETARY_SUPPLEMENT

Commercially available 100% tart cherry juice

100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)

Intervention Type DIETARY_SUPPLEMENT

Placebo beverage

Placebo beverage

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Tart Cherry N185 Vita Cherry Sport N1244 "gold standard" beverage

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* • 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.
* 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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Army Research Institute of Environmental Medicine

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracey Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

United States Army Research Institute of Environmental Medicine

Locations

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USARIEM

Natick, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tracey J Smith, PhD

Role: CONTACT

Phone: 5082062390

Email: [email protected]

Robert Roussel, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Tracey J Smith, PhD

Role: primary

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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24-07

Identifier Type: -

Identifier Source: org_study_id