Status:
UNKNOWN
Influence of Body Weight and Composition on Immune Recovery
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Conditions:
BMI/Body Composition
Eligibility:
All Genders
18-39 years
Brief Summary
Immune dysfunction in individuals with obesity, secondary to chronic inflammation, may have an acute impact on War fighter health and readiness, and subsequent lethality. Indeed, \~51% of military per...
Detailed Description
See brief summary above.
Eligibility Criteria
Inclusion
- Are between the ages of 18 (or 17 for military personnel) and 39 (i.e., consistent with the age range of 95% of Active Duty enlisted and 75% of Active Duty officers)
- Have a Body Mass Index (BMI) in the range of 18.5 to \<25 kg/m2 and have a percent body fat by circumference measurements that meets the Army's max allowable body fat standards for individuals classified as "without obesity"; or have a BMI ≥ 30 kg/m2 and have a percent body fat by circumference measurements that exceeds the Army's max allowable body fat standards for individuals classified as "with obesity" (40).
- Have been weight stable (+/- 5 lbs.) for the past two months (not including temporary body weight fluctuations due to menstrual cycle) and agree not to attempt to lose or gain weight for the duration of the study;
- Participate in 120-300 mins of aerobic exercise over the course of at least 3 days per week as indicated by self-report data and confirmed during the study via actigraphy (i.e., consistent with the self-reported exercise habits of a majority of active duty military personnel) (1, 41)
- Are willing to participate in all study procedures and comply with all study instruction.
- Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide documentation of oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)
- Pass a general medical clearance.
Exclusion
- have a tattoo on both forearms that obscures the forearms and doesn't allow space for the suction blister induction;
- experienced more than a \~5 lbs. weight gain or loss in the last month than is not transient (e.g., menstrual).
- participate in more than 300 minutes of aerobic exercise per week as indicated by self-report data and confirmed during the study via actigraphy (i.e., consistent with self-reported exercise habits of \~20% of active duty military personnel) (1, 41).
- are habitually taking nonsteroidal anti-inflammatory drugs (e.g., Advil), aspirin, lipid-lowering drugs, corticosteroids or immunosuppressants (e.g. Humira);
- are immune-compromised (e.g., chemotherapy or radiation treatment);
- are suffering from an autoimmune disease (e.g., lupus);
- recovering from a surgery within the past 6 months;
- Current doctor-diagnosed and/or treated diabetes, hypertension or dyslipidemia
- are suffering from sleep apnea;
- smoke, dip, chew or vape tobacco or nicotine-containing products.
- regularly (more than 2 days per week) sleep less than 7 hours or more than 9 hours per night; or, take a nap 3 or more days per week.
- Pregnant or lactating
- problems with blood clotting (in the subset of participants receiving muscle biopsies only)
- allergy to lidocaine (in the subset of participants receiving biopsies only)
- Females Only:
- • Have abnormal menstrual cycles (not between 26-32 days in duration; or not 5-6 menstrual cycles within the past 6 month) or those that have had an intrauterine device (IUD) placed with the last month or removed within the past 3 months.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04737681
Start Date
September 1 2020
End Date
September 1 2024
Last Update
October 26 2022
Active Locations (1)
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1
U.S. Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760