Anti Inflammatory, Bone and Joint Health, Cardiovascular Health, Cognitive Function and Mental Health, Digestive Health, Energy and Vitality, Exercise Tolerance, General Health and Wellness, Immune Support, Obesity, Skin, Hair, and Nail Health, Sleep and Relaxation, Sports Performance and Recovery, Weight Management
Conditions
Keywords
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
Brief 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.
Detailed description
The purpose of this study is to explore potential positive human health effects of a proprietary nutraceutical formulation known as M4C. The impetus for M4C came from Dr. McGraw's attempt to alleviate the chronic inflammation a family member was experiencing through a non-invasive, natural, nutraceutical approach. Anecdotal findings of M4C show an antiinflammatory effect (observed in the presence of inflammatory conditions and after traumatic injury such as a sprain or fall), improved metabolic, gastrointestinal, and mental health, as well as enhanced exercise response and recovery. In this study the investigators will examine whether supplementation with M4C is associated with any changes in lipids, clinical chemistries, body composition, questionnaire covariates, metabolites/novel suspected lipopeptides, hemoglobin A1C, or bone mineral density.
Interventions
DIETARY_SUPPLEMENTM4C
Nutraceutical designed to enhance novel metabolic pathway activity.
Sponsors
Concordia University Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open label single arm intervention pilot
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults
Exclusion criteria
* 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 * inability to fast i.e. low blood sugar * pregnant or may be pregnant during the course of the study * amino acid metabolizing disorder i.e. phenylketonuria * severe edema * did not pass screening criteria as determined by MRI facility * allergies/intolerance to any nutraceutical ingredients: amino acids, vitamins, minerals, tapioca starch, sunflower lecithin, stevia, limes or fatty acids like docosahexaenoic acid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Pain | Monthly for 3 months | Self reported chronic pain as follows: Self rated from 0-10 Zero is no pain, 10 is worst pain imaginable |
| Body composition | 3 months | Dexa scan for bone mineral density |
| Hemoglobin A1C | 3 months | measured glycated hemoglobin via whole capillary blood |
| Resting Systolic blood pressure | Monthly for 3 months | measured via Omron Platinum digital upper arm blood pressure monitor |
| Resting Diastolic blood pressure | Monthly for 3 months | measured via Omron Platinum digital upper arm blood pressure monitor |
| Resting Pulse | Monthly for 3 months | measured via Omron Platinum digital upper arm blood pressure monitor |
| Blood lipids | Monthly for 3 months | measured via blood lipid analyzer from whole capillary blood |
| Anxiety | Monthly for 3 months | 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 |
| General Mental Health | Monthly for 3 months | User rating as follows: Excellent, Very good, Good, Fair, Poor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Saliva Melatonin and Cortisol | 3 months | 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. |
Contacts
Primary ContactJoseph McGraw
Backup ContactKevin Gries
Outcome results
None listed