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RiteStart Personal Nutritional Dietary Study

NCT ID: NCT05130905

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2017-12-20

Brief Summary

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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

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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.

Conditions

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Healthy Nutrition

Keywords

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Immunity Salivary IgA Bovine Colostrum Brain Health Heart Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Supplementation with RiteStart

Once enrolled into the study, participants were instructed to take RiteStart Supplement daily for 12 weeks.

Group Type EXPERIMENTAL

RiteStart Supplement

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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4Life Research, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Vollmer, PhD

Role: STUDY_CHAIR

4Life Research, LLC

Locations

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4Life Research

Sandy City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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RSC-012-00

Identifier Type: -

Identifier Source: org_study_id