Recruiting

Cocoa-Rich Bioflavanol

Sponsor:

United States Army Research Institute of Environmental Medicine

Code:

NCT04359082

Conditions

Cold Exposure

Manual Dexterity

Gut Microbiome

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

CocoaVia supplement

Placebo Pill

Study Details

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 understand whether bioflavanol supplementation can change the gut microbiome.

Conditions

Cold Exposure

Manual Dexterity

Gut Microbiome

Study ID

NCT04359082

Start date

Jan 13, 2020

Status verified date

Apr, 2021

Completion date

Sep, 2021

Anticipated

Primary completion date

May, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo for 8 straight days

experimental: Bioflavanol

Bioflavanol supplementation for 8 days at 900 mg flavanol per day

Interventions

CocoaVia supplement

CocoaVia is a dietary supplement that has concentrated bioflavanols of 225 mg flavanols per pill along with 30 mg theobromine and 10 mg caffeine

Placebo Pill

Placebo pill has no bioflavanols with 30 mg theobromine and 10 mg caffeine

Primary outcome measure

  • Cold induced vasodilation response [ Time Frame: 30 minutes ]
  • Manual dexterity-PP [ Time Frame: 2 hours ]
  • Manual dexterity-MRM [ Time Frame: 2 hours ]
  • Hand and finger temperatures [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

John W Castellani, PhD

508-206-2195john.w.castellani.civ@mail.mil

Billie Alba, PhD

508-206-2171billie.k.alba.civ@mail.mil

Locations

John W Castellani

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

John W Castellani, PhD

508-206-2195john.w.castellani.civ@mail.mil

Principal Investigator:

John W Castellani, PhD

More Information

Sponsor

United States Army Research Institute of Environmental Medicine

Last update posted

Apr 30, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Army Research Institute of Environmental Medicine on 2021-04-30.