Testing a Novel Dairy Protein to Counteract Immunosenescence

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT03557463
Collaborator
(none)
21
2
12.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dairy protein
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Controlled, randomized, double blind pilot studyControlled, randomized, double blind pilot study
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Supplements were coded based on protein type and both participants and researchers were blinded to the underlying code
Primary Purpose:
Treatment
Official Title:
Use of UV-treated Milk Powder to Increase Vaccine Efficacy in the Elderly
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Soy protein

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).

Dietary Supplement: Dairy protein
A controlled, randomized, double blind pilot study was conducted using two different protein sources as nutritional supplementation to enhance vaccine response.

Experimental: Dairy protein

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).

Dietary Supplement: Dairy protein
A controlled, randomized, double blind pilot study was conducted using two different protein sources as nutritional supplementation to enhance vaccine response.

Outcome Measures

Primary Outcome Measures

  1. Immune response to vaccine [8 weeks]

    Difference in DTaP vaccine antibodies at before and after vaccine

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT03557463
Other Study ID Numbers:
  • 1164896
First Posted:
Jun 15, 2018
Last Update Posted:
Jun 15, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2018