RiteStart Personal Nutritional Dietary Study

Not Applicable

Completed

• Conditions: Healthy Nutrition
• Interventions: Dietary Supplement: RiteStart Supplement

• Registration Number: NCT05130905
• Lead Sponsor: 4Life Research, LLC

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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2017-12-19
• Study Completion: 2017-12-20
• Study First Submitted: 2021-10-22
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-11
• Last Update Submitted: 2021-11-11
• Study First Posted: 2021-11-23
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supplementation with RiteStart	RiteStart Supplement	Once enrolled into the study, participants were instructed to take RiteStart Supplement daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Serum folate level	12 weeks	Serum folate level was measured in blood sample collected from participants
Serum vitamin B12 level	12 weeks	Serum vitamin B12 level was measured in blood sample collected from participants
Salivary IgA	12 weeks	Secretory Immunoglobulin A (sIgA) was measured in saliva collected from participants.
Serum vitamin D level	12 weeks	Serum vitamin D level was measured in blood sample collected from participants

Secondary Outcome Measures

Name	Time	Method
Aspartate Aminotransferase (AST) activity	12 weeks	AST activity is measured in blood sample collected from participants. ALT, AST, and GGT are important biomarkers for liver function and commonly used for safety assessment
Gamma-Glutamyl Transpeptidase (GGT) activity	12 weeks	GGT activity is measured in blood sample collected from participants. ALT, AST, and GGT are important biomarkers for liver function and commonly used for safety assessment
Alanine Aminotransferase (ALT) Activity	12 weeks	ALT activity is measured in blood sample collected from participants. ALT, AST, and GGT are important biomarkers for liver function and commonly used for safety assessment

Trial Locations

Locations (1)

4Life Research; 🇺🇸 Sandy, Utah, United States