M4C Nutraceutical Intervention Human Health Effects Pilot
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Body composition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
排除标准
- •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
研究组 & 干预措施
M4C Treatment
Single arm study with nutraceutical M4C treatment. Proprietary blend of amino acids, fatty acids, vitamins, and minerals. 1 tbsp in 12 oz of water with two algae oil capsules taken by mouth one to two times daily.
干预措施: M4C (Dietary Supplement)
结局指标
主要结局
Body composition
时间窗: 3 months
Dexa scan for bone mineral density
Resting Pulse
时间窗: Monthly for 3 months
measured via Omron Platinum digital upper arm blood pressure monitor
General Mental Health
时间窗: Monthly for 3 months
User rating as follows: Excellent, Very good, Good, Fair, Poor
Resting Systolic blood pressure
时间窗: Monthly for 3 months
measured via Omron Platinum digital upper arm blood pressure monitor
Resting Diastolic blood pressure
时间窗: Monthly for 3 months
measured via Omron Platinum digital upper arm blood pressure monitor
Blood lipids
时间窗: Monthly for 3 months
measured via blood lipid analyzer from whole capillary blood
Hemoglobin A1C
时间窗: 3 months
measured glycated hemoglobin via whole capillary blood
Anxiety
时间窗: 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
Chronic Pain
时间窗: Monthly for 3 months
Self reported chronic pain as follows: Self rated from 0-10 Zero is no pain, 10 is worst pain imaginable
次要结局
- Saliva Melatonin and Cortisol(3 months)
研究者
Joseph McGraw
Professor
Concordia University Wisconsin