Safety and Efficacy of a Multivitamin, Multimineral, Bovine Colostrum Containing Supplement RiteStart: An Open Label Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Serum folate level
研究概览
简要总结
This study is undertaken to explore the effects of a bovine colostrum containing MVM (RiteStart) on different health aspects by quantitatively assessing relevant serum and saliva biomarkers, over a 12-week period in participants.
详细描述
Blood samples were drawn by a certified phlebotomist, prepared, and then analyzed by a Clinical Laboratory Improvement Amendments (CLIA)-certified independent laboratory. The following components were measured in sera from the participants: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-Glutamyl Transpeptidase (GGT), Red Blood Cell Count (RBC), Hematocrit (HCT), Mean Cell Volume (MCV), Mean Cell Hemoglobin (MCH), Mean Cell Hemoglobin Concentration (MCHC), Red Cell Distribution Width (RDW), Platelets, Mean Platelet Volume (MPV), Monocytes, Neutrophils, Lymphocytes, Eosinophils, Basophils, Hemoglobin, Ferritin, Total Iron Binding Capacity (TIBC), Iron, Transferrin Saturation (TS), Folate, Vitamin B12, Calcium, Vitamin D, Magnesium, Red Blood Cell Magnesium, Potassium, Sodium, Creatine Kinase (CK), Testosterone, Free Testosterone, Dehydroepiandrosterone-sulfate (DHEAS), Cortisol, Sex Hormone Binding Globulin (SHBG), Albumin, Glucose, Total Cholesterol, High-Density Lipoprotein cholesterol (HDL), Low-Density Lipoprotein cholesterol (LDL), Triglycerides, White Blood Cell Count (WBC), High Sensitivity C-Reactive Protein (hsCRP). Secretory Immunoglobulin A (sIgA) was measured in saliva collected from participants.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Employees and family and friends of employees.
- •Adults committed to attend all of the sessions and follow the instructions described in Experimental Design.
- •Participants of both genders and of ages >18 will be included.
- •Participants with the best chance to benefit from taking the product, i.e., participants that are not in the optimal health/level as per answers in the health questionnaire, but that are not diseased.
排除标准
- •Pregnant and nursing women.
- •Those currently taking 4Life TF Plus and/or other supplements containing vitamins, minerals, and essential fatty acids (EPA/DHA, fish oil, omega 3), and those that have taken any of these supplements up to 1 month prior to first study visit.
- •Those participants that reported to take daily medications to treat a chronic condition. However, birth control pill does not count.
- •Those participants with allergies to any of the ingredients of the product including high sensitivity to lactose.
- •Participants that smoke and with body mass index (BMI) either < 19 or > 30 will also be excluded.
结局指标
主要结局
Serum folate level
时间窗: 12 weeks
Serum folate level was measured in blood sample collected from participants
Serum vitamin B12 level
时间窗: 12 weeks
Serum vitamin B12 level was measured in blood sample collected from participants
Salivary IgA
时间窗: 12 weeks
Secretory Immunoglobulin A (sIgA) was measured in saliva collected from participants.
Serum vitamin D level
时间窗: 12 weeks
Serum vitamin D level was measured in blood sample collected from participants
次要结局
- Aspartate Aminotransferase (AST) activity(12 weeks)
- Gamma-Glutamyl Transpeptidase (GGT) activity(12 weeks)
- Alanine Aminotransferase (ALT) Activity(12 weeks)