Bioavailability of Ration Items Containing Tart Cherry Extract

NCT07063173 | Recruiting

• 1 other identifier: 24-07
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioavailability

Keywords

military; tart cherry; muscle recovery; polyphenols

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and postprandially @ 30-minutes, 60-minutes, 120-minutes, 240-minutes, 360-mins, 24 hours

Secondary Outcomes (1)

• Postprandial concentrations of polyphenols in urine

  Baseline and postprandially @ Baseline and postprandially @ 30-minutes, 60-minutes, 120-minutes, 240-minutes, 360-mins, 24 hours

Study Arms (4)

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.

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.

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..

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.

Dietary Supplement: Fruit Bar; Dietary Supplement: Powdered Drink; Dietary Supplement: Commercially available 100% tart cherry juice

Interventions

Fruit Bar DIETARY_SUPPLEMENT

Tart Cherry N185

Also known as: Tart Cherry N185

Control Beverage; Powdered Drink; Tart Cherry Juice

Powdered Drink DIETARY_SUPPLEMENT

Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)

Also known as: Vita Cherry Sport N1244

Control Beverage; Fruit Bar; Tart Cherry Juice

Commercially available 100% tart cherry juice DIETARY_SUPPLEMENT

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

Also known as: "gold standard" beverage

Control Beverage; Fruit Bar; Powdered Drink

Placebo beverage DIETARY_SUPPLEMENT

Placebo beverage

Fruit Bar; Powdered Drink; Tart Cherry Juice

Eligibility Criteria

• Age: 17 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

RECRUITING

Study Officials

• Tracey Smith, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracey J Smith, PhD

CONTACT

5082062390; tracey.smith10.civ@health.mil

Robert Roussel, PhD

CONTACT

robert.r.roussel.civ@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: One of four test food items will be consumed on the morning of each test trial (randomly assigned).
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: July 14, 2025
• Study Start: June 14, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)