A Nutritional Field Study for the Management of Primary Hyperlipidemia in Dogs

This study is to evaluate the effectiveness of a Low Fat Dry Canine Dog Food for the management or primary hyperlipidemia in dogs. The investigators hypothesize that feeding this food over an 8-week period will decrease fasting serum triglycerides in dogs diagnosed with primary hyperlipidemia. This is a prospective, blinded (to the owner), multi-site field study.

INCLUSION CRITERIA
•    Generally healthy, non-obese adult dogs (Body Condition Score 4-7/9)
•    At or over 2 years of age (Ideally >7 yrs)
•    All breeds but preferably miniature Schnauzers & Shetland Sheepdogs
•    Have not had nor are currently being treated for medical conditions shown
below in the Exclusion Criteria
•    The dog has been diagnosed with primary hyperlipidemia on Day -7 screening: Fasting serum triglyceride ≥ 500 mg/dL
•    The dog’s daily diet has not changed in the past 30 days 

Dogs will be screened for the study prior to inclusion with a physical exam and lab work including a complete blood count, serum chemistry, SDMA, Total T4, Spec cPLI, Urinalysis, and ACTH stimulation test. Dogs diagnosed with primary hyperlipidemia during the screening visit may be included in the study (Fasting serum triglyceride ≥ 500 mg/dL)
Dog's do not need to be previously diagnosed with hyperlipidemia in order to be screened for the study.

EXCLUSION CRITERIA
For a dog to be eligible for study enrollment, none of the following exclusion criteria can be met:
1.    The dog has received a diagnosis of, or is currently exhibiting symptoms of, a secondary form of hyperlipidemia, such as: 
       a.    Endocrine disorders: (diabetes mellitus, hypothyroidism, hyperadrenocorticism, pancreatitis
       b.    Other causes: obesity (Body Condition Score 8-9/9), lymphoma, cholestasis, protein losing nephropathy, glucocorticoid administration
2.    Screening visit lipid profile: Fasting serum triglyceride ≤ 499 mg/ 
3.    The dog has been diagnosed with, or is currently exhibiting symptoms of, significant organ disease, such as liver or kidney disease or heart failure
4.    The dog has been treated with steroids (eg. estrogen, progesterone) within the past 7 days
5.    The dog has been treated with short acting systemic corticosteroids within the past 7 days or intermediate to long acting systemic corticosteroids within the past 30 days (topical/ophthalmic corticosteroids will be allowed)
6.    The dog’s daily diet has changed in the past 30 days
7.    The dog will not eat or tolerate the investigational diet
8.    The dog is pregnant

OWNER INCENTIVES
Owners will receive an incentive if their dog successfully completes the study in the form of a $25 Gas Card and a $75 Gift Card
•    All study procedures, including laboratory testing will be covered by the sponsor. The screening visit includes a Complete Blood Count, Serum Chemistry, SDMA, Spec cPLI, Total T4, Urinalysis, and ACTH Stimulation Test. If the patient is enrolled in the study, additional lab work will be performed at Day 35 (Complete Blood Count, Serum Chemistry, SDMA, and Spec cPLI) and Day 63 (Complete Blood Count, Serum Chemistry, SDMA, Spec cPLI, and urinalysis) of the study.
•    The investigational dog food will be provided by the sponsor.
•    Study data will be recorded on paper forms. Owners will be required to complete forms at home. 

CONTACT
Martha Cline, DVM, Diplomate ACVN
Clinical Nutrition Department
Red Bank Veterinary Hospital
197 Hance Ave, Tinton Falls, NJ 07724      
 (732) 747-3636