IP Library Granted Patent US 12667601
Granted Patent B2
US 12667601 · App. 17/403,025 · Granted Jun 30, 2026

Compositions for increasing resilience to traumatic brain injury

Inventors: Elizabeth E. Ignowski (Vaudreuil-Dorion, CA); Daniel A. Linseman (Littleton, CO)
Assignee: IMMUNOTEC INC.
A61K38/17A61P25/00
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Quick Facts
Patent No.
US 12667601
App. No.
17/403,025
Granted
Jun 30, 2026
Kind
B2
Abstract

Provided herein are methods, compositions, and uses thereof for preventing traumatic brain injury (TBI) in a subject, wherein a composition comprising whey protein isolate and/or whey protein concentrate may be administered to a subject pre-injury, thereby increasing resilience of the subject to TBI.

Claims (34)

1 . A method of ameliorating traumatic brain injury (TBI) symptoms in a subject, said method comprising:

assessing the subject's cognitive function pre-TBI;

administering 20 g of a composition consisting of whey protein isolate and/or whey protein concentrate to the subject pre-injury, wherein the composition is administered orally, twice daily for 5 days per week, over a period of 28 days prior to the TBI; and

assessing the subject's cognitive function 10-16 days post-TBI, wherein the subject's cognitive function 10-16 days post-TBI is equal to the subject's cognitive function pre-TBI.

2 . The method according to claim 1 , wherein the composition is administered at least 4 weeks prior to injury.

3 . The method according to claim 1 , wherein the composition is administered to the subject beginning at least about 4 weeks prior to injury or prior to performing an activity for which there is a risk of injury.

4 . The method according to claim 1 , wherein administration of the composition attenuates a reduction in brain GSH/GSSG ratio following injury as compared to an untreated control.

5 . The method according to claim 1 , wherein administration of the composition attenuates motor function and/or cognitive function deficit following injury as compared to an untreated control.

6 . The method according to claim 1 , wherein administration of the composition preserves corpus callosum width and/or axonal myelination following injury as compared to an untreated control.

7 . The method according to claim 1 , wherein administration of the composition attenuates neuron degeneration following injury as compared to an untreated control.

8 . The method according to claim 1 , wherein administration of the composition reduces Iba1 microglial marker immunoreactivity in the brain following injury as compared to an untreated control.

9 . The method according to claim 1 , wherein administration of the composition reduces demyelination of the corpus callosum following injury as compared to an untreated control.

10 . The method according to claim 1 , wherein administration of the composition reduces number of foci of degenerating neurons following injury as compared to an untreated control.

11 . The method according to claim 1 , wherein the composition comprises a non-denatured whey protein supplement, wherein the whey protein supplement comprises:

about 3.0 g/L of β-lactoglobulin (MW 18,400),

about 1.2 g/L of α-lactalbumin (MW 14,200),

about 0.3 g/L of BSA (bovine serum albumin; MW 69,000),

about 0.2 g/L of Lactoferrin (MW 77,000),

about 0.2 g/L of IgG (MW 160,000),

about 0.6 g/L of PP-3 (proteose-peptone 3; MW 22,000),

about 0.6 g/L of PP-5 (proteose-peptone 5; MW 14,300),

about 0.6 g/L of PP-8f (proteose-peptone 8f; MW 4,100), and

about 1.6 g/L of NPN (non-protein nitrogen).

12 . A method of ameliorating traumatic brain injury (TBI) symptoms in a subject, said method comprising:

identifying the subject as being at risk for receiving a TBI based on one or more risk factors;

assessing the subject's cognitive function pre-TBI;

administering 20 g of a composition consisting of a whey protein isolate and/or whey protein concentrate to the subject identified as being at risk for TBI pre-injury, wherein the composition is administered orally, twice daily for 5 days per week, over a period of 28 days prior to the TBI; and

assessing the subject's cognitive function 10-16 days post-TBI, wherein the subject's cognitive function 10-16 days post-TBI is equal to the subject's cognitive function pre-TBI.

13 . The method according to claim 12 , wherein the one or more risk factors comprise occupational risk, risk associated with planned activities, or a predisposition or susceptibility of the subject to head injury or brain damage.

14 . The method according to claim 12 , further comprising a step of:

identifying a known risk date on which the subject has elevated risk for TBI based on the one or more risk factors, and identifying a protective treatment start date which is prior to the known risk date;

wherein administration of the composition to the subject in the step of administering begins on or before the protective treatment start date.

15 . The method according to claim 14 , wherein the protective treatment start date is at least about 4 weeks prior to the known risk date.

16 . The method according to claim 14 , wherein the protective treatment start date is at least about 4 weeks prior to the known risk date, and the composition is administered at about 20 grams per day for 5 days per week beginning on or before the protective treatment start date.