Evaluation of Fortetropin® on Quality of Life and Activity in Geriatric Dogs
Purpose and Explanation of Study:
This clinical trial will evaluate whether supplementing Fortetropin in geriatric dogs’ normal diet improves their quality of life as assessed by a standardized quality of life questionnaire and overall activity, as monitored by a collar-based wearable sensor.
Fortetropin is a freeze-dried fertilized egg yolk product added to the food, for the potential to reverse the muscle loss associated with aging and improve mobility, activity, and quality of life in geriatric dogs. Fortetropin acts in the body to reduce myostatin, a protein produced by the body that inhibits muscle cell growth and proliferation.
What does enrollment into this trial involve?
Week 0 (Initial Visit): Dogs will be evaluated with physical examination, blood work, and urinalysis (if not performed within the last 3 months,) to determine if they are eligible to participate in the study. If eligible, dogs will have additional blood drawn (6-12mL) for serum myostatin measurement. Owners will complete a quality of life survey and their dog will be fitted with a Vetrax wearable activity monitor. Owners will receive instruction on the use of the Vetrax monitor. Enrolled dogs will be randomized and sent home with either Fortetropin or a placebo. Neither the owners nor the investigators will know which supplement enrolled dogs will be receiving.
Week 2: The owner will now begin adding the study supplement to their dog’s food once daily at home. It is important to follow directions for the study supplement, making sure each meal is eaten entirely. Mixing the study supplement with canned food is acceptable to facilitate complete ingestion. The entire monitoring period, while receiving the supplement, is 12 weeks.
Owners will be contacted every two weeks to assess for any difficulties with the use of the activity collar or with administration/tolerance of the supplement.
Week 8: Owner will be asked to complete a second quality of life questionnaire.
Week 14: A recheck visit to the VHC for complete physical examination, removal/return of Vetrax collar, and a final quality of life questionnaire will be completed by owner. Blood will again be collected (6-12mL) for serum myostatin measurement at this final visit.
Geriatric dogs visiting the KSU VHC for their semi-annual routine health screening with the Pet Health Center or following an evaluation for any non-life threatening disease with one of the specialty services.
Dogs must have a recognized age-associated weakness, weight loss, slowed or altered mobility, or exercise intolerance that is not caused by any other chronic disease and are otherwise considered healthy for their age.
Dogs must meet the minimum age requirement:
<9.1 kg: 9 years of age (small)
9.5-22.1 kg: 8 years of age (medium)
23.2-54.5 kg: 7 years of age (large)
>54.5 kg: 6 years of age (giant)Enrolled dogs can be on medications for seizures, osteoarthritis, allergies or atopy, diabetes mellitus, hyperadrenocorticism, or any other medication that would not impact their participation.
- Enrolled dogs can be on medications for seizures, osteoarthritis, allergies or atopy, diabetes mellitus, hyperadrenocorticism, or any other medication that would not impact their participation.
Dogs will be excluded if they have any of the following: cancer affecting any internal organ, chronic kidney disease of IRIS Stage 3 or greater, Stage C or D endocardiosis, dilated cardiomyopathy, chronic hepatitis with evidence of hepatic failure, megaesophagus, structural intracranial disease, degenerative myelopathy, or any other disease that the investigator feels would significantly and negatively impact survival.
If there have not been any routine health tests (CBC, chemistry, urinalysis) performed within the prior 3 months, these will be performed and covered by the study. The study will cover the cost of the initial appointment if it does not occur at a regularly scheduled, semi-annual Pet Health appointment. Study funds will also cover the Week 14 recheck visit. The study supplement (Fortetropin or placebo) will be provided free of charge to the owner. At the end of the study, 2 canisters of Myos Canine Muscle Formula will be provided free to the owner.
For more information, please contact Misty Bear, Clinical Trials Coordinator:
Phone: (785)532-3046; E-mail: ClinicalTrials@vet.k-state.edu