Bioavailability of Ration Items Containing Tart Cherry Extract
NCT ID: NCT07063173
Last Updated: 2025-12-29
Study Results
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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RECRUITING
NA
15 participants
INTERVENTIONAL
2024-06-14
2025-12-31
Brief Summary
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Detailed Description
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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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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
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.
Fruit Bar
Tart Cherry N185
Powdered Drink
Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)
Placebo beverage
Placebo beverage
Fruit Bar
The fruit powder is incorporated into a snack bar, which delivers \~120 mg of anthocyanins.
Powdered Drink
Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)
Commercially available 100% tart cherry juice
100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)
Placebo beverage
Placebo beverage
Powdered Drink
The fruit powder is incorporated into a powdered drink, which delivers \~120 mg of anthocyanins..
Fruit Bar
Tart Cherry N185
Commercially available 100% tart cherry juice
100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)
Placebo beverage
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.
Fruit Bar
Tart Cherry N185
Powdered Drink
Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)
Commercially available 100% tart cherry juice
100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)
Interventions
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Fruit Bar
Tart Cherry N185
Powdered Drink
Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)
Commercially available 100% tart cherry juice
100% concentrated Montmorency cherry juice (CherryActive, Sunbury, UK)
Placebo beverage
Placebo beverage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
17 Years
39 Years
ALL
Yes
Sponsors
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United States Army Research Institute of Environmental Medicine
FED
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Tracey J Smith, PhD
Role: primary
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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24-07
Identifier Type: -
Identifier Source: org_study_id