Health TrialsbyHealthPanel

Bioavailability of Ration Items Containing Tart Cherry Extract

ConditionBioavailability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-39
SponsorUnited States Army Research Institute of Environmental Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

• 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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Fruit Bar

    Dietary supplement

    Tart Cherry N185

  • Powdered Drink

    Dietary supplement

    Vita Cherry Sport N1244 (FutureCeuticals, Momence, IL)

  • Commercially available 100% tart cherry juice

    Dietary supplement

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

  • Placebo beverage

    Dietary supplement

    Placebo beverage

Treatment groups

15 Participants
are divided into 4 treatment groups
Group A: Tart Cherry JuiceActive comparator 3 interventions
Group B: Fruit BarActive comparator 3 interventions
Group C: Powdered DrinkActive comparator 3 interventions
Group D: Control BeveragePlacebo comparator 3 interventions

Trial outcomes

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).

Time frame
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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

United States Army Research Institute of Environmental Medicine

Lead sponsor

Source ClinicalTrials.gov
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