About this trial
This 3 month pilot study will be an unblinded, convenience sampling, nutraceutical intervention trial. Twenty fasted subjects will undergo a baseline health assessment via a questionnaire, baseline clinical chemistries, blood lipids, dexa and impedence testing (to identify bone mineral density and body muscle/fat/water composition), and metabolite/novel biomarker testing through whole capillary blood, saliva, and urine collections. Assessments will be repeated every month (3 times after initial assessment) to cover a 3 month period. All measurements from each visit will be compared with baseline using paired t-tests or Chi square testing depending on variable. Power analyses are not included due to the pilot nature of the study. This pilot study will provide the necessary variability estimates for future trials.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults
Disqualifiers
amputation
blood clotting disorder
metal implants or implanted electrical device(s)
known acute or chronic illness; gastrointestinal, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension
Trial design
Single group
Treatments tested in this trial
M4C
Dietary supplementNutraceutical designed to enhance novel metabolic pathway activity.
Treatment groups
Trial outcomes
Primary outcomes
Body composition
Dexa scan for bone mineral density
Body composition
Dexa scan for body fat distribution
Body composition
Dexa scan for body muscle distribution
Hemoglobin A1C
measured glycated hemoglobin via whole capillary blood
Secondary outcomes
Saliva Melatonin and Cortisol
Concentrations of melatonin and cortisol in saliva (ng/ml) will be collected before bedtime and at rising. Sample melatonin and cortisol will be measured via High Performance liquid chromatography with mass spectrometry (HPLC MS/MS) as potential markers of stress state. Values will be assessed for conformance to reported reference ranges in the literature. Values outside the reference ranges will be considered positive for unhealthy stress response.
Locations
Sponsors and contacts
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