Induced Physiological Ketosis in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is evaluating of efficacy of innovative dietary strategy -stimulation of physiological ketosis with Liquid Technology Formula PanTrek, in patients with asthenia and or decreased tolerance to physical and\or mental exertion. PanTrek is a liquid formula of potassium and magnesium salts of beta-oxibutiric acid, ginsenosides and rosmarinic acid.

Detailed Description
-----------------
It will be double-blind, placebo-controlled study in 88 patients of both sex, aged from 18 to 65. Patients will be randomly assigned to one of two groups: placebo or IP group in 1:1 proportion. Study instruments: D-Fis, MoCA, TMT, VAS, assessment of blood keton concentration before and after first and last administration per os of 25 ml of placebo or PanTrek. PanTrek will be served in ampuls, 25 ml per ampule. The duration of the study will be 15 days of treatment and 15 days of follow-up observation. Patients will be assessed at screening/baseline, after 15 days and after 30 days. The dose regimen: the shot of PanTrek, 25 ml, will be administered per os, twice per day, in the morning and in the evening, per se or deluted in 100 ml of water one hour before or after meal.

Official Title
-----------------
Efficacy of Physiological Ketosis Induced by Liquid Technology Formula PanTrek in Asthenia and\or Decreased Tolerance to Physical and\or Mental Exertion (Double-blind, Placebo-controlled Study)

Conditions
-----------------
Patient Activation

Intervention / Treatment
-----------------
* Dietary Supplement: PanTrek


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent diagnosis of astenia and/or decreased tolerance to physical and\or mental exertion ability of patients to understand assessment procedures Exclusion Criteria: intollerance of components of PanTrek participation in other trials

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Patients will recieve matched by taste and color shot of 25 ml liquid in ampules | Dietary Supplement: PanTrek<br>* administration of exogenouse keton body<br>|
| Experimental: Active treatment group<br>Patients will recieve shot of PanTrek 25 ml in anpules | Dietary Supplement: PanTrek<br>* administration of exogenouse keton body<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome | Difference of changes of visual analog scale (VAS) indices between active treament and placebo groups. Minimum value - 0, maximum value - 100 scores. The higher score means the better condition. The major difference means better outcome. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| indused ketosis | increase of ketons level from baseline to the end of the active treatment period of the study | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiological Ketosis, PanTrek, Asthenia, Physical functioning, Mental functioning, beta-oxibutiric acid