Status:
UNKNOWN
Cocoa-rich Bioflavanol Supplementation Effects During Cold Exposure
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Conditions:
Cold Exposure
Manual Dexterity
Eligibility:
All Genders
18-49 years
Phase:
NA
Brief Summary
The primary purpose is to test whether cocoa-rich bioflavanols can improve blood flow to the hand and fingers and improve hand function/dexterity during cold exposure. Secondary purpose is to understa...
Detailed Description
Loss of manual dexterity significantly impacts Warfighter effectiveness and lethality on the cold-weather battlefield. Identifying countermeasures that improve hand and finger temperatures, hand and f...
Eligibility Criteria
Inclusion
- Age - 18-49 years (17-49 for active military).
- Refrain from the following for 2 weeks before and during the study (including the washout period): consumption of flavanol rich foods including cocoa, chocolate, apples, red, white, and sweet wine, apricots, blueberries, peaches/nectarines, plums, grapes, strawberries, pecans (no more than ½ cup/day, pistachios, (no more than ½ cup per day), and apple juice.
- Participants not to change their daily intakes of tea (green or black) or coffee.
Exclusion
- History of cold injuries.
- Raynaud's syndrome.
- Cold-induced asthma/bronchospasm
- Difficulty swallowing pills.
- Previous hand/finger injuries that impair dexterity and hand function.
- Metal hardware (plates/screws) in the forearms and hands.
- Blood donation in last 8 weeks.
- Medicine use (including any over the counter medication such as Tylenol, Advil, Sudafed, etc…), with the exception of birth control and a multi-vitamin.
- Known allergies to medical adhesives or cocoa/chocolate.
- History of disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery.
- No planned MRI during the study or within 2 days after completing a cold test.
- Use of dietary supplements (to include probiotics and prebiotics), with exception of multi-vitamin containing up to 100% of the recommended daily allowance (RDA).
- No exercise or smoking within 8 hours of testing.
- Pregnant or breastfeeding.
- Oral antibiotic use within 3 months of study participation.
- Inability or unwillingness to not consume fermented food products or prebiotic-containing food products for 2 weeks prior to and throughout study participation. Examples include kefir, kombucha, aged cheese, pickles, sauerkraut, sour cream, tempeh, yogurt, kimchi, miso, vinegar, sourdough bread, wine and beer.
- Colonoscopy within 3 months of study participation.
- On average has a bowel movement less frequently than every other day.
Key Trial Info
Start Date :
January 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04359082
Start Date
January 13 2020
End Date
September 1 2021
Last Update
April 30 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
John W Castellani
Natick, Massachusetts, United States, 01760