Testing a Novel Dairy Protein to Counteract Immunosenescence

NCT03557463 | Completed

• 1 other identifier: 1164896
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immunodeficiency

Outcome Measures

Primary Outcomes (1)

• Immune response to vaccine

  Difference in DTaP vaccine antibodies at before and after vaccine

  8 weeks

Study Arms (2)

Soy protein

ACTIVE COMPARATOR

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

Dairy protein

EXPERIMENTAL

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

Interventions

Dairy protein DIETARY_SUPPLEMENT

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

Dairy protein; Soy protein

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of California, Davis: lead

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Supplements were coded based on protein type and both participants and researchers were blinded to the underlying code
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled, randomized, double blind pilot study

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 30, 2017
• Last Updated: April 11, 2023

Record last verified: 2023-04