Oral Dietary Supplement for U.S. Navy Dolphins
Navy SBIR 2018.2 - Topic N182-128
ONR - Ms. Lore-Anne Ponirakis - email@example.com
Opens: May 22, 2018 - Closes: June 20, 2018 (8:00 PM ET)
Explosive Ordnance Disposal Underwater Programs (SEA00 EOD/CREW-2)
OBJECTIVE: Develop a safe and
stable oral dietary supplement to support bottlenose dolphin health including
normalization of such things as white blood cell count, neutrophil count,
erythrocyte sedimentation rate, hematocrit, and levels of insulin,
triglycerides, ferritin, iron, globulins, alanine aminotransferase,
gamma-glutamyl transferase, and/or aspartate aminotransferase toward reference
DESCRIPTION: The U.S. Navy
works with bottlenose dolphins (Tursiops truncatus) in the fleet’s operational
Marine Mammal Systems to protect harbors and Navy assets, and to detect and/or
mark underwater mines. Mission success depends on the sustained fitness and
health of the U.S. Navy marine mammals. Recently, studies have described
metabolic conditions in U.S. Navy dolphins, including metabolic syndrome, iron
overload, and nephrolithiasis [Refs 1-4]. While most of these metabolic
conditions are also observed in wild, free-ranging dolphins, studies suggest
that there may be a higher prevalence of metabolic conditions in U.S. Navy
dolphins, likely due to their advanced age, and differences in fish diets and
feeding strategies [Refs 5, 6]. Recently, it has been identified that a change
in the primary fish types fed to U.S. Navy dolphins correlated with changes in
blood-based indicators of chronic, low-level inflammation, anemia, liver
conditions, and iron overload (i.e., white blood cell count, neutrophil count,
erythrocyte sedimentation rate, hematocrit, and concentration of globulins,
alanine aminotransferase, gamma-glutamyl transferase, aspartate
aminotransferase and iron) suggesting the possibility that diet impacted the
PHASE I: Phase I Base
PHASE II: Develop the oral
dietary supplement and establish its dosing, toxicity (using in vitro and
laboratory animal studies), pharmacokinetics, and pharmacodynamics. Determine
guidelines for storage of the supplement as well as the dolphin dosing amount,
dosing frequency, and therapeutic blood levels. Demonstrate in at least one
laboratory animal study and one dolphin field study that the oral dietary
supplement successfully and safely raises blood levels of the targeted
nutrients and improves white blood cell count, neutrophil count, erythrocyte
sedimentation rate, hematocrit, and levels of insulin, triglycerides, ferritin,
iron, globulins, alanine aminotransferase, gamma-glutamyl transferase, and/or
aspartate aminotransferase. Refine the oral dietary supplement into an initial
supplement formulation based on the results of the Phase II proof-of-concept
study. Begin the process to ensure that the product meets all U.S. Food and
Drug Administration (FDA) and/or United States Pharmacopeia (USP) certification
for quality and safety [Ref 8].
PHASE III DUAL USE
APPLICATIONS: Support the U.S. Navy in transitioning the oral supplement for
its intended use in Navy dolphins. Commercialize the oral dietary supplement.
In addition to the military market, the technology could have applicability in
non-military marine mammal populations, with the potential to benefit other
domestic and exotic animal populations.
1. Venn-Watson, S., et al.
“Blood-based Indicators of Insulin Resistance and Metabolic Syndrome in
Bottlenose Dolphins (Tursiops truncatus).” Frontiers in Endocrinology, Vol. 4,
Article 136 (2013). doi: 10.3389/fendo.2013.00136
2. Mazzaro, L., et al. “Iron
Indices Among Bottlenose Dolphins (Tursiops truncatus): Identifying Populations
at Risk for Iron Overload.” Comparative Medicine, Vol. 62, pp. 508-515 (2012).
3. Johnson, S., et al. “Use
of Phlebotomy Treatment in Atlantic Bottlenose Dolphins with Iron Overload.”
Journal of the American Veterinary Medical Association, Vol. 235, pp. 194-200
(2009). doi: 10.2460/javma.235.2.194
4. Smith, C., et al.
“Pathophysiological and Physicochemical Basis of Ammonium Urate Stone Formation
in Dolphins.” The Journal of Urology, Vol. 192, pp. 260-266 (2014). doi:
5. Venn-Watson, S., et al.
“Adrenal Gland and Lung Lesions in Gulf of Mexico Common Bottlenose Dolphins
(Tursiops truncatus) Found Dead Following the Deepwater Horizon Oil Spill.”
PLOS ONE Vol. 10, pp. e0126538 (2015). doi: 10.1371/journal.pone.0126538
6. Wells, R., et al.
“Evaluation of Potential Protective Factors Against Metabolic Syndrome in
Bottlenose Dolphins: Feeding and Activity Patterns of Dolphins in Sarasota Bay,
Florida.” Frontiers in Endocrinology, Vol. 4, Article 139 (2014). doi:
7. Venn-Watson, S., et al.
“Increased Dietary Intake of Saturated Fatty Acid Heptadecanoic Acid (C17:0)
Associated with Decreasing Ferritin and Alleviated Metabolic Syndrome in
Dolphins.” PLOS ONE Vol. 10, pp. e0132117 (2015). doi:
8. “Guidance for Industry:
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements; Small Entity Compliance Guide”.
U.S. Food and Drug Administration, December 2010. https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm238182.htm
KEYWORDS: Marine Mammal
Health; Bottlenose Dolphin; Metabolic Syndrome; Iron Overload; Nephrolithiasis;
Diet; Dietary Supplement