Cocoa-rich Bioflavanol Supplementation Effects During Cold Exposure

Status Recruiting

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04359082
Study type	Interventional
Source	United States Army Research Institute of Environmental Medicine
Contact	John W Castellani, PhD
Phone	508-206-2195
Email	john.w.castellani.civ@mail.mil
Status	Recruiting
Phase	N/A
Start date	January 13, 2020
Completion date	September 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05793112` - INF108F in Infants With Food Protein Induced Proctocolitis	Phase 4
Active, not recruiting	`NCT04327141` - Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women	N/A
Recruiting	`NCT04117321` - Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
Recruiting	`NCT05655910` - Enhanced Nutritional Optimization in LVAD Trial	N/A
Recruiting	`NCT03325855` - Fecal Microbiota Transplant National Registry
Active, not recruiting	`NCT05931471` - Yogurt and GI Health	N/A
Recruiting	`NCT03797417` - Gut Microbiome and Metabolic Pathways Changes in Vitiligo
Withdrawn	`NCT06006416` - Effect of Fenugreek Fibre on Gut Microbiome	Phase 3
Recruiting	`NCT06206486` - The Gut Microbiome and Serum Metabolites as a Biological Mechanism Underlying Pain in Kidney Transplantation
Completed	`NCT02655250` - Neonatal Microbiome Validity Study
Recruiting	`NCT05670288` - Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
Not yet recruiting	`NCT03975764` - Fecal Microbiota in Preterm Birth
Completed	`NCT03219931` - NEOBIFI: Clinical Trial for the Prevention and/or Reduction of the Incidence of Colics in Infants	Phase 4
Recruiting	`NCT04447365` - The Correlation Between Gut Microbiome-host Interaction and Ventricular Arrhythmias.
Recruiting	`NCT04466072` - Gut Microbiome and Ventricular Arrhythmias
Not yet recruiting	`NCT06130137` - Gut Microbiome in People Living With HIV and HBV
Recruiting	`NCT06260579` - Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity	N/A
Completed	`NCT04511052` - Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women	Phase 1/Phase 2
Recruiting	`NCT06404749` - Fungal Fiber for Gut Health	N/A
Completed	`NCT04031222` - Mechanisms of Inflammation, Immunity, Islet Cell and Intestinal Hormone Changes in Youth at Risk for Diabetes

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.