NCT04359082

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

March 9, 2020

Last Update Submit

April 27, 2021

Conditions

Cold ExposureManual DexterityGut Microbiome

Outcome Measures

Primary Outcomes (4)

  • Cold induced vasodilation response

    Skin/finger temperature changes during finger immersion in 4°C water

    30 minutes

  • Manual dexterity-PP

    Purdue Pegboard score during 8°C air exposure. Score is the number of pegs placed into board.

    2 hours

  • Manual dexterity-MRM

    Minnesota Rate of Manipulation dexterity score during 8°C air exposure. Score is the number of pieces put together during times period.

    2 hours

  • Hand and finger temperatures

    Hand and finger temperatures during cold air exposure in 8

    2 hours

Secondary Outcomes (1)

  • Gut microbiome

    8 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo for 8 straight days

Other: Placebo Pill

Bioflavanol

EXPERIMENTAL

Bioflavanol supplementation for 8 days at 900 mg flavanol per day

Dietary Supplement: CocoaVia supplement

Interventions

CocoaVia supplementDIETARY_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

Bioflavanol
Placebo PillOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John W Castellani

Natick, Massachusetts, 01760, United States

RECRUITING

Related Publications (1)

  • Alba BK, Greenfield AM, Yurkevicius BR, Jones ML, Castellani JW. Short-term cocoa bioflavanol supplementation does not improve cold-induced vasodilation in young healthy adults. Eur J Appl Physiol. 2024 May;124(5):1523-1534. doi: 10.1007/s00421-023-05380-4. Epub 2023 Dec 27.

    PMID: 38150009DERIVED

Study Officials

  • John W Castellani, PhD

    US Army Research Institute of Environmental Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John W Castellani, PhD

CONTACT

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

Billie Alba, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, double-blind, cross-over controlled trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

April 24, 2020

Study Start

January 13, 2020

Primary Completion

May 1, 2021

Study Completion

September 1, 2021

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)