Nutrition and physical performance Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 to 40 years at time of consent. 2. Trained male and female members of the Corps of Cadets or Active Military. 3. Medically cleared to participate in Corps of Cadets or Active Military physical training activities. 4. Ability to comply with study procedures. 5. Agree to only ingest meals provided during the study 6. Agree to refrain from alcohol intake and use of non-steroidal anti-inflammatory (NSAIDs), aspirin, and other over-the-counter pain medications for 48 hours prior to and after completion of each testing session. 7. Availability to complete the study based on the durations of individual visits and scheduling requirements.
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding, or wishing to become pregnant during the study. 2. Have an orthopedic limitation that would prevent participation in the Army Combat Fitness Test. 3. Have taken weight loss dietary supplements or medications during the last 2 weeks. 4. Have a history within the previous 12 months of alcohol or substance abuse. 5. Are a heavy smoker (>1 pack/day within the past 3 months). 6. Have known allergy to pork protein (loin, ham) or plant-based proteins (e.g., soybeans, Tempeh, Tofu, beans, lentils, peas, Jackfruit, mushrooms, seitan wheat-based protein).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Markers of catabolism (urinary nitrogen excretion, blood urea nitrogen (BUN) to creatinine ratio, testosterone to cortisol ratio) measured using Fasting blood draws sent to Clinical Pathology Laboratories Inc before testing, 24, 48-, and 72-hours post-testing 2. Markers of inflammation (TNFa, INF?, cortisol, interleukin (IL) cytokines ( IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10)) measured using Fasting blood draws sent to Clinical Pathology Laboratories Inc before testing, 24, 48-, and 72-hours post-testing 3. Markers of oxidative stress (MDA), general immune stress (neutrophil to lymphocyte ratio), muscle enzyme efflux/damage (CRP, ESR, CK, LDH) measured using Fasting blood draws sent to Clinical Pathology Laboratories Inc before testing, 24, 48-, and 72-hours post-testing 4. Muscle soreness measured using the Visual Analogue Scale (VAS) score before testing, 24, 48-, and 72-hours post-testing 5. Cognitive function measured using 1. the Trail Making Test (TMT); 2. the Profile of Mood States (POMS); 3. the Psychomotor Vigilance Task Test (PVTT) before testing, 24, 48-, and 72-hours post-testing 6. Performance measured using a vertical jump anaerobic power test and the Army Combat Fitness Test (ACFT) performance measured using a Vertec vertical jump tester and the ACFT consisting of; 1. the 3-Repetition Maximum Deadlift (MDL); 2. the Standing Power Throw Test (SPT); 3. the Hand Release Push-Up – Arm Extension Test (HRP); 4. the Sprint-Drag-Carry Test (SDC); 5.) the Plank Test (PLK); 6.) the Two-Mile Run (2MR) before testing and then at 72 hours post-testing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Whole blood red and white cell counts with percent differentials (white blood cells, red blood cells, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, neutrophils, lymphocytes, monocytes, eosinophils, basophils, immature granulocytes, nucleated red blood cells, platelets) measured using Fasting blood draws sent to Clinical Pathology Laboratories Inc before testing and then at 24, 48, and 72 hours post-testing 2. A standard serum clinical safety panel including glucose, blood lipids (triglycerides, total cholesterol, HDL, LDL, VLDL, estimated glomerular filtration rate, potassium, sodium, chloride, carbon dioxide, calcium, total protein, albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase) measured using Fasting blood draws sent to Clinical Pathology Laboratories Inc. before testing, 24,48, and 72 hours post-testing 3. Food satisfaction/side effects (e.g., GI distress, constipation, diarrhea, fatigue, abdominal discomfort, nausea, headaches, and heartburn), and frequency and severity of general side effects (dizziness, racing heart rate, palpitations, shortness of breath, nervousness, blurred vision, other) measured using Food Satisfaction Questionnaires and Side Effects Questionnaires before testing, and then at 24,48, and 72 hours post-testing | — |
Countries
United States of America