NCT05130905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

October 22, 2021

Last Update Submit

November 11, 2021

Conditions

Healthy Nutrition

Keywords

ImmunitySalivary IgABovine ColostrumBrain HealthHeart Health

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Alanine Aminotransferase (ALT) Activity

    12 weeks

  • Aspartate Aminotransferase (AST) activity

    12 weeks

  • Gamma-Glutamyl Transpeptidase (GGT) activity

    12 weeks

Study Arms (1)

Supplementation with RiteStart

EXPERIMENTAL

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

Dietary Supplement: RiteStart Supplement

Interventions

RiteStart SupplementDIETARY_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.

Supplementation with RiteStart

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4Life Research

Sandy City, Utah, 84070, United States

Location

Study Officials

  • David Vollmer, PhD

    4Life Research, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 23, 2021

Study Start

September 1, 2017

Primary Completion

December 19, 2017

Study Completion

December 20, 2017

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)