Cocoa-rich Bioflavanol Supplementation Effects During Cold Exposure

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Cold Exposure, Manual Dexterity, Gut Microbiome

In brief

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 understand whether bioflavanol supplementation can change the gut microbiome.

Key facts

Study ID

NCT04359082

Run by

United States Army Research Institute of Environmental Medicine

People needed

40

Starts

2020-01-13

Expected to finish

2021-09-01

Last updated by the study team

2021-04-30

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• John W Castellani — Natick, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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