An interventional study of Dairy protein in Immunodeficiency, sponsored by University of California, Davis. Completed. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-11.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
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.
698 studies on the registry are indexed under Immunologic Deficiency Syndromes; 67 are open to participants now.
This study's enrollment of 21 is below the median of 56 across 455 interventional studies indexed under Immunologic Deficiency Syndromes.
Browse Immunologic Deficiency Syndromes studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
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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.
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
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.
Immune response to vaccine
Difference in DTaP vaccine antibodies at before and after vaccine
Time frame: 8 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Immunologic Deficiency Syndromes→
University of California, Davis