Clinical trial NCT05130905: RiteStart Personal Nutritional Dietary Study
Official title: Safety and Efficacy of a Multivitamin, Multimineral, Bovine Colostrum Containing Supplement RiteStart: An Open Label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Nutrition
Keywords: Immunity
Salivary IgA
Bovine Colostrum
Brain Health
Heart Health
Lead sponsor: 4Life Research, LLC
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Employees and family and friends of employees.
2. Adults committed to attend all of the sessions and follow the instructions described in Experimental Design.
3. Participants of both genders and of ages \>18 will be included.
4. 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.

Exclusion Criteria

1. Pregnant and nursing women.
2. 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.
3. Those participants that reported to take daily medications to treat a chronic condition. However, birth control pill does not count.
4. Those participants with allergies to any of the ingredients of the product including high sensitivity to lactose.
5. Participants that smoke and with body mass index (BMI) either \< 19 or \> 30 will also be excluded.

Primary outcomes:
measure: Salivary IgA
timeFrame: 12 weeks
measure: Serum folate level
timeFrame: 12 weeks
measure: Serum vitamin B12 level
timeFrame: 12 weeks
measure: Serum vitamin D level
timeFrame: 12 weeks
Secondary outcomes:
measure: Alanine Aminotransferase (ALT) Activity
timeFrame: 12 weeks
measure: Aspartate Aminotransferase (AST) activity
timeFrame: 12 weeks
measure: Gamma-Glutamyl Transpeptidase (GGT) activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sandy
country: United States
facility: 4Life Research
state: Utah
Study officials:
affiliation: 4Life Research, LLC
name: David Vollmer, PhD
role: STUDY_CHAIR
References: