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

Sponsor

Ketonic Pharm LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05689697

Collaborator

(none)

Enrollment

Location

Arms

7.2

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Activation	Dietary Supplement: PanTrek	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

randomized asignment to placebo or IP group, double-blind design

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Jan 9, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Aug 15, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Placebo group

Patients will recieve matched by taste and color shot of 25 ml liquid in ampules

Dietary Supplement: PanTrek

administration of exogenouse keton body

Experimental: Active treatment group

Patients will recieve shot of PanTrek 25 ml in anpules

Dietary Supplement: PanTrek

administration of exogenouse keton body

Outcome Measures

Primary Outcome Measures

Primary outcome [15 days]
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.

Secondary Outcome Measures

indused ketosis [15 days]
increase of ketons level from baseline to the end of the active treatment period of the study

Other Outcome Measures

Improvement in cognitive function [15 days]
Difference in improvement in total scores of Montreal Cognitive Assessment (MoCA) between the treatment and placebo groups. Minimum value - 0, maximum value - 30 scores. The higher score means the better condition. The major difference means better outcome.
Improvement in visual attention and task switching. [15 days]
Difference in improvement of total time of Trial Making Test (TMT) execution between the treatment and placebo groups. Normal value - 29 seconds for A part and 75 seconds for B part. The higher time means worse condition. Decrease of spended time means improvement or negative score, if the last result is substractes from the first result, means improvement.
Improvement in physical function [15 days]
Difference in improvement in total scores of Daily Fatigue Investigation Scale (D-Fis) between the treatment and placebo groups. Minimum value - 0, maximum value - 32 scores. The higher score means the worse condition. The major difference means better outcome.
Safety profile in active and follow-up period [30 days]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 on the first, 15th and 30th day.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

informed consent
diagnosis of astenia and/or decreased tolerance to physical and\or mental exertion
ability of patients to understand assessment procedures