M4C Nutraceutical Intervention Human Health Effects Pilot
NCT Number: NCT06476236
Acronym: M4C Pilot
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: General Health and Wellness|Energy and Vitality|Cognitive Function and Mental Health|Weight Management|Digestive Health|Exercise Tolerance|Cardiovascular Health|Bone and Joint Health|Skin, Hair, and Nail Health|Immune Support|Sports Performance and Recovery|Sleep and Relaxation|Obesity|Anti Inflammatory
Interventions: DIETARY_SUPPLEMENT: M4C
Sponsor: Concordia University Wisconsin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-06-17
Completion Date: 2025-06-17

Summary:
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.

Primary Outcome Measures: Body composition, Dexa scan for bone mineral density, 3 months|Body composition, Dexa scan for body fat distribution, 3 months|Body composition, Dexa scan for body muscle distribution, 3 months|Hemoglobin A1C, measured glycated hemoglobin via whole capillary blood, 3 months|Resting Systolic blood pressure, measured via Omron Platinum digital upper arm blood pressure monitor, Monthly for 3 months|Resting Diastolic blood pressure, measured via Omron Platinum digital upper arm blood pressure monitor, Monthly for 3 months|Resting Pulse, measured via Omron Platinum digital upper arm blood pressure monitor, Monthly for 3 months|Blood lipids, measured via blood lipid analyzer from whole capillary blood, Monthly for 3 months|Anxiety, Measured via Generalized Anxiety Disorder (GAD-7) questionnaire Scoring as follows 0-4: No anxiety, 5-9:Mild anxiety, 10-14:Moderate anxiety, 15-21: Severe anxiety, Monthly for 3 months|General Mental Health, User rating as follows: Excellent, Very good, Good, Fair, Poor, Monthly for 3 months|Chronic Pain, Self reported chronic pain as follows: Self rated from 0-10 Zero is no pain, 10 is worst pain imaginable, Monthly for 3 months
Secondary Outcome Measures: 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., 3 months