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

Patient Activation Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05689697
• Other study ID #: KetonicPharm
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: December 2022
• Source: Ketonic Pharm LLC
• Contact: Denis Burminskiy, MD, PhD
• Phone: +79262344633
• Email: desbur[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: August 15, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenia
• Ketosis
• Patient Activation

Intervention

Dietary Supplement:
• PanTrek
administration of exogenouse keton body

Locations

Country	Name	City	State
Russian Federation	Laboratory of psychopharmacology Research center of mental health	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Ketonic Pharm LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in cognitive function	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.	15 days
Other	Improvement in visual attention and task switching.	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.	15 days
Other	Improvement in physical function	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.	15 days
Other	Safety profile in active and follow-up period	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 on the first, 15th and 30th day.	30 days
Primary	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	indused ketosis	increase of ketons level from baseline to the end of the active treatment period of the study	15 days