Cold ExposureNCT04359082
Cocoa-rich Bioflavanol Supplementation Effects During Cold Exposure
A study testing CocoaVia supplement in people with Cold Exposure and Manual Dexterity, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Cold Exposure, Manual Dexterity, Gut Microbiome
- What is being tested?
- CocoaVia supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
John W Castellani
Natick, Massachusetts, 01760
John W Castellani, PhD, 508-206-2195, john.w.castellani.civ@mail.mil
John W Castellani, PhD
About this study
Official title: The Effects of Cocoa-rich Bioflavanol Supplementation on Manual Dexterity During Cold Exposure
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.
Read the 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 finger blood flow, manual dexterity, and thermal comfort may lead to better Warfighter performance. A primary purpose of this study is to test the efficacy of a commercial off-the-shelf cocoa-rich bioflavanol product on hand/finger blood flow and temperature, manual dexterity, and thermal comfort during whole-body cold exposure. Another primary purpose is to determine the effect of bioflavanols on the finger cold-induced vasodilation (CIVD) response to cold-water immersion. Secondary purposes are to determine if: a) cocoa-rich flavanols stimulate the growth of beneficial gut bacteria and b) impact attention and effort perception during dexterity task completion in the cold. Two experimental studies (n = 20 in each study, 10 women and 10 men, 18-49 yr) will be conducted. Experiment #1 consists of immersing the middle finger in cold water (4°C) for 30 minutes; experiment #2 consists of whole-body cold exposure (8°C air, 90-min exposure, wearing cold-weather clothing but bare-handed). In both experiments, outcomes will be measured after both acute flavanol or placebo ingestion and chronic ingestion of flavanol/placebo (8 days of supplementation). Daily flavanol ingestion will be 900 mg/day. Volunteers will serve as their own controls in this crossover, double-blind research design. The washout period between flavanol and placebo treatments will be at least 2 weeks (longer for women who will be tested only during the follicular phase). Measurements during these tests include skin temperature, skin blood flow, fine and gross motor dexterity, thermal comfort, and effort perception. Fecal samples, in both experiments, will be collected before and after 8 days of cocoa-rich bioflavanol supplementation to examine if bioflavanol supplementation increases the number of beneficial bacteria in the gut microbiome. Information from this study will inform combat nutrition developers about the efficacy of cocoa-rich bioflavanols and possible inclusion into cold-weather field rations.
- Conditions
- Cold Exposure, Manual Dexterity, Gut Microbiome
- Being tested
- CocoaVia supplement, Placebo Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Placebo PillOther
Placebo pill has no bioflavanols with 30 mg theobromine and 10 mg caffeine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo for 8 straight days Receives: Other: Placebo Pill |
| Bioflavanol | Experimental | Bioflavanol supplementation for 8 days at 900 mg flavanol per day Receives: Dietary Supplement: CocoaVia supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold induced vasodilation response
Skin/finger temperature changes during finger immersion in 4°C water
Measured: 30 minutes
Manual dexterity-PP
Purdue Pegboard score during 8°C air exposure. Score is the number of pegs placed into board.
Measured: 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.
Measured: 2 hours
Hand and finger temperatures
Hand and finger temperatures during cold air exposure in 8
Measured: 2 hours
Secondary outcomes (1)
Gut microbiome
How do targeted populations (Bifidobacterium spp., Lactobacillus spp., C. coccoides-Eubacterium rectale, Faecalibacterium prausnitzii, Prevotella/Bacteroides, Roseburia, and Akkermansia muciniphila) change as a result of bioflavanol supplementation
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start13 Jan 2020
- Primary completionMay 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cold ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, cross-over controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John W Castellani, PhD, Principal investigator, US Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359082
- Sponsor's protocol ID
- 18-27-H
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38150009
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cocoa-rich Bioflavanol Supplementation on Manual Dexterity During Cold Exposure
- ClinicalTrials.gov ID
- NCT04359082
- Acronym / sponsor ID
- 18-27-H
- Conditions
- Cold Exposure, Manual Dexterity, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 finger blood flow, manual dexterity, and thermal comfort may lead to better Warfighter performance. A primary purpose of this study is to test the efficacy of a commercial off-the-shelf cocoa-rich bioflavanol product on hand/finger blood flow and temperature, manual dexterity, and thermal comfort during whole-body cold exposure. Another primary purpose is to determine the effect of bioflavanols on the finger cold-induced vasodilation (CIVD) response to cold-water immersion. Secondary purposes are to determine if: a) cocoa-rich flavanols stimulate the growth of beneficial gut bacteria and b) impact attention and effort perception during dexterity task completion in the cold. Two experimental studies (n = 20 in each study, 10 women and 10 men, 18-49 yr) will be conducted. Experiment #1 consists of immersing the middle finger in cold water (4°C) for 30 minutes; experiment #2 consists of whole-body cold exposure (8°C air, 90-min exposure, wearing cold-weather clothing but bare-handed). In both experiments, outcomes will be measured after both acute flavanol or placebo ingestion and chronic ingestion of flavanol/placebo (8 days of supplementation). Daily flavanol ingestion will be 900 mg/day. Volunteers will serve as their own controls in this crossover, double-blind research design. The washout period between flavanol and placebo treatments will be at least 2 weeks (longer for women who will be tested only during the follicular phase). Measurements during these tests include skin temperature, skin blood flow, fine and gross motor dexterity, thermal comfort, and effort perception. Fecal samples, in both experiments, will be collected before and after 8 days of cocoa-rich bioflavanol supplementation to examine if bioflavanol supplementation increases the number of beneficial bacteria in the gut microbiome. Information from this study will inform combat nutrition developers about the efficacy of cocoa-rich bioflavanols and possible inclusion into cold-weather field rations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, cross-over controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo PillPlacebo for 8 straight days |
| Bioflavanol | Experimental | Dietary Supplement: CocoaVia supplementBioflavanol supplementation for 8 days at 900 mg flavanol per day |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- History of cold injuries.
- Raynaud's syndrome.
- Cold-induced asthma/bronchospasm
- Difficulty swallowing pills.
- Previous hand/finger injuries that impair dexterity and hand function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CocoaVia supplementCocoaVia is a dietary supplement that has concentrated bioflavanols of 225 mg flavanols per pill along with 30 mg theobromine and 10 mg caffeine | Dietary supplement | Bioflavanol |
| Placebo PillPlacebo pill has no bioflavanols with 30 mg theobromine and 10 mg caffeine | Other | Placebo |
Primary outcome
Cold induced vasodilation response
Time frame: 30 minutes
Skin/finger temperature changes during finger immersion in 4°C water
Manual dexterity-PP
Time frame: 2 hours
Purdue Pegboard score during 8°C air exposure. Score is the number of pegs placed into board.
Manual dexterity-MRM
Time frame: 2 hours
Minnesota Rate of Manipulation dexterity score during 8°C air exposure. Score is the number of pieces put together during times period.
Hand and finger temperatures
Time frame: 2 hours
Hand and finger temperatures during cold air exposure in 8
1 secondary outcome
Gut microbiome
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 38150009Alba 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Castellani, PhD principal investigator
US Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CocoaVia supplement in people with Cold Exposure and Manual Dexterity, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John W Castellani, PhD (508-206-2195, john.w.castellani.civ@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cold induced vasodilation response (time frame: 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.