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Completed

NCT Number: NCT05130905

RiteStart Personal Nutritional Dietary Study

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.

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Key information

Conditions

Healthy Nutrition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

4Life Research

Sandy City, Utah, 84070, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

RiteStart Supplement

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.

Primary outcomes

  1. Salivary IgA

    Time frame: 12 weeks

    Secretory Immunoglobulin A (sIgA) was measured in saliva collected from participants.

  2. Serum folate level

    Time frame: 12 weeks

    Serum folate level was measured in blood sample collected from participants

  3. Serum vitamin B12 level

    Time frame: 12 weeks

    Serum vitamin B12 level was measured in blood sample collected from participants

  4. Serum vitamin D level

    Time frame: 12 weeks

    Serum vitamin D level was measured in blood sample collected from participants

Secondary outcomes

  1. Alanine Aminotransferase (ALT) Activity

    Time frame: 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

  2. Aspartate Aminotransferase (AST) activity

    Time frame: 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

  3. Gamma-Glutamyl Transpeptidase (GGT) activity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

4Life Research, LLC

Industry

Registry information

Official study title

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

Acronym: RESPOND

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 23, 2021
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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