RiteStart Personal Nutritional Dietary Study (RESPOND)

Safety and Efficacy of a Multivitamin, Multimineral, Bovine Colostrum Containing Supplement RiteStart: An Open Label Trial

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.

Study Overview

• Status: Completed
• Conditions: Healthy Nutrition
• Intervention / Treatment: Dietary supplement: RiteStart Supplement

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Sandy, Utah, United States, 84070
      • 4Life Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supplementation with RiteStart; Once enrolled into the study, participants were instructed to take RiteStart Supplement daily for 12 weeks.

Dietary supplement: RiteStart Supplement; RiteStart is a comprehensive multivitamin, multimineral, all-in-one daily supplement. Besides having comprehensive and balanced amounts of essential vitamins and minerals that the human body needs, RS includes many other health-promoting ingredients. For example, RS contains potent antioxidants, including vitamins A, C, and E, oligomeric proanthocyanidins from pinebark and grapeseed extracts, lutein, CoQ10, alpha-lipoic acid, and green tea. It is also a source of essential fatty acids from fish and plant oils. RS contains transfer factor (bovine colostrum and egg yolk extracts) that support immunity [6, 7, 8]. RS also includes a blend of maitake mushrooms, shiitake mushrooms, cordyceps, inositol hexaphosphate, olive leaf extract, and other ingredients that aim to further support immune function and overall health.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alanine Aminotransferase (ALT) Activity	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	12 weeks
Aspartate Aminotransferase (AST) activity	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	12 weeks
Gamma-Glutamyl Transpeptidase (GGT) activity	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	12 weeks

Collaborators and Investigators

• Sponsor: 4Life Research, LLC
• Investigators: Study Chair: David Vollmer, PhD, 4Life Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 19, 2017
• Study Completion (Actual): December 20, 2017

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Immunity; Bovine Colostrum; Brain Health; Salivary IgA; Heart Health
• Other Study ID Numbers: RSC-012-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No