Forsøksdyr: The effect of Nx4 on salivary cortisol in dogs under physical stress (copy)

Godkjenningsdato 12.09.2018

Godkjenningsperiode 01.10.2018-30.12.2019

Purpose of the study

Stress in pets is a widely documented problem in veterinarian practice. The stress levels in dogs correlate to the amount of cortisol in serum and/or saliva. Stress can be induced by psychosocial or physical stress. Under stressful conditions cortisol is released via the ACTH axis. In recent studies, it has been shown that under physical stress the cortisol level increases in Norwegian sled dogs induced by high endurance exercise. The increase in blood cortisol induced by endurance exercise seems to correlate to the grade and numbers of gastritis and gastric ulcers in sled dogs. In addition, high endogenous cortisol levels can lead to immune suppression.
In human medicine, a well-known biological complex medicine has been shown to reduce plasma cortisol in test persons during a so called Trier Stress test. The great advantage of natural multicomponent, multitarget medicine is the superior tolerability even if used over a long period of time.
The aim of this study is to determine if Nx4 can reduce the salivary/ blood cortisol level in dogs under physical stress.

Expected distress of the dogs

The dogs will be tested at the beginning of their normal winter training. After the summer break, the dogs will start with their regular training. At one of the first training days, we will take blood and salivary samples. The procedures should be of minimal stress for the dogs. This is also of great importance for the results of the study. The person taking blood from the dogs is very experienced and the procedures is fast (60sec/ per blood draw) to minimize any stress for the dogs.

Expected scientific benefit

The goal of the study is to prevent the negative impact of cortisol, for example gastritis and gastric ulcers in Norwegian sled dogs. Endogenous corticosteroids induced by stress seem to be responsible for increased epithelial permeability in the gastrointestinal tract, causing gastritis. Gastritis, gastric ulcers and Aspiration pneumonia caused by gastric ulcers is the number one cause for severe illness and death in sled dogs in long distance trails.

How many dogs will be part of the study

The study will be divided into two parts. In the first part, we will test 20 dogs. The first part is to verify that the length of the training is sufficient to cause an increase in plasma and salivary cortisol. In addition, the first part will show the range of the values. The results from the first part will help to calculate the number of dogs needed for the second part of the study to have a sufficient power.
The second part is a randomized and blinded study. The dogs will be assigned according to age, weight, sex and blood lactate level (parameter for training level). The second part of the study will take place one year later, after the next summer break. It is assumed that 20 dogs per group are needed. Group A will receive Nx4 and Group B will receive placebo.