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Testing a Novel Dairy Protein to Counteract Immunosenescence

Primary Purpose

Immunodeficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dairy protein
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immunodeficiency

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers
Inclusion criteria included participants be more than 60 years of age. Volunteers underwent a physical examination and health assessment by a physician to ensure the absence of exclusion criteria which were regular consumption of greater than one unit of milk and/or milk products (milk, yogurt, fresh cheese, etc.) a day at the time of enrollment, known milk allergy, food faddism, other non-traditional diet, prolonged consumption of dairy supplements (greater than one daily during the previous four weeks), use of tobacco products in the previous 10 years, underlying neoplasia or immunological disease, including hypergammaglobunemia, renal disease or failure, use of steroids or immunosuppressive drugs in the previous eight weeks, reduced physical activity (New York Heart Association classes III-IV). Having received a DTaP vaccine within the last five years was an exclusion criteria for the study, but patient records were incomplete for many volunteers on this aspect. Therefore, volunteers with an initial Tetanus antibody level above 3 IU/mL were excluded from the study results as the volunteer was assumed to have had the DTaP vaccine within the last 5 years.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Soy protein

    Dairy protein

    Arm Description

    Low isoflavone soy protein powder: Each participant was required to consume a total of 112 servings for the 8-week duration of the study. A 4-week supply was provided at baseline (week 0) and at the time of vaccine administration (week 4).

    UV-C treated raw milk protein supplement (TruActiv MPC 85). Each participant was required to consume a total of 112 servings for the 8-week duration of the study. A 4-week supply was provided at baseline (week 0) and at the time of vaccine administration (week 4).

    Outcomes

    Primary Outcome Measures

    Immune response to vaccine
    Difference in DTaP vaccine antibodies at before and after vaccine

    Secondary Outcome Measures

    Full Information

    First Posted
    June 5, 2018
    Last Updated
    April 9, 2023
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03557463
    Brief Title
    Testing a Novel Dairy Protein to Counteract Immunosenescence
    Official Title
    Use of UV-treated Milk Powder to Increase Vaccine Efficacy in the Elderly
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    August 1, 2017 (Actual)
    Study Completion Date
    August 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Aging populations experience a decline in adaptive immune system function also known as immunosenesence. Nutritional approaches to stimulate and strengthen the immune system are needed for this growing segment of the population. A controlled, randomized, double blind pilot study was conducted using two different protein sources as nutritional supplementation to enhance vaccine response. Our objective was to examine the immune stimulating effects of dairy protein subjected to ultraviolet radiation (UV-C) radiation treatment process instead of pasteurization. Participants were 21 healthy individuals over 60 years of age who consumed 6 g of the dairy protein or a comparison, soy isoflavone protein, twice a day for eight weeks. DTaP vaccine administered at week 4. Non-parametric t-tests revealed a significant increase in Tetanus antibodies in the dairy group compared to the soy group at week 8. These findings suggest additional benefits of UV-C treated unheated dairy protein as a solution to counteract immunosenescence, but warrant further study in elderly and other populations that might benefit from immune system stimulation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immunodeficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Controlled, randomized, double blind pilot study
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Supplements were coded based on protein type and both participants and researchers were blinded to the underlying code
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Soy protein
    Arm Type
    Active Comparator
    Arm Description
    Low isoflavone soy protein powder: Each participant was required to consume a total of 112 servings for the 8-week duration of the study. A 4-week supply was provided at baseline (week 0) and at the time of vaccine administration (week 4).
    Arm Title
    Dairy protein
    Arm Type
    Experimental
    Arm Description
    UV-C treated raw milk protein supplement (TruActiv MPC 85). Each participant was required to consume a total of 112 servings for the 8-week duration of the study. A 4-week supply was provided at baseline (week 0) and at the time of vaccine administration (week 4).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Dairy protein
    Intervention Description
    A controlled, randomized, double blind pilot study was conducted using two different protein sources as nutritional supplementation to enhance vaccine response.
    Primary Outcome Measure Information:
    Title
    Immune response to vaccine
    Description
    Difference in DTaP vaccine antibodies at before and after vaccine
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria included participants be more than 60 years of age. Volunteers underwent a physical examination and health assessment by a physician to ensure the absence of exclusion criteria which were regular consumption of greater than one unit of milk and/or milk products (milk, yogurt, fresh cheese, etc.) a day at the time of enrollment, known milk allergy, food faddism, other non-traditional diet, prolonged consumption of dairy supplements (greater than one daily during the previous four weeks), use of tobacco products in the previous 10 years, underlying neoplasia or immunological disease, including hypergammaglobunemia, renal disease or failure, use of steroids or immunosuppressive drugs in the previous eight weeks, reduced physical activity (New York Heart Association classes III-IV). Having received a DTaP vaccine within the last five years was an exclusion criteria for the study, but patient records were incomplete for many volunteers on this aspect. Therefore, volunteers with an initial Tetanus antibody level above 3 IU/mL were excluded from the study results as the volunteer was assumed to have had the DTaP vaccine within the last 5 years.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Testing a Novel Dairy Protein to Counteract Immunosenescence

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