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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Activation
• Intervention / Treatment: Dietary supplement: PanTrek

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 Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denis Burminskiy, MD, PhD; Phone Number: +79262344633; Email: desbur@gmail.com
• Study Contact Backup: Name: Allan Beniashvili, MD, PhD; Phone Number: +79859259676; Email: beniashvilia@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115522
    • Laboratory of psychopharmacology Research center of mental health
    • Contact: Allan Beniashvili, MD, PhD; Phone Number: +79859259676; Email: beniashvilia@yandex.ru
    • Contact: Denis Burminsiy, MD, PhD; Phone Number: +79262344633; Email: desbur@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Ketonic Pharm LLC
• Investigators: Study Director: Denis Burminskiy, MD, PhD, Mental Health Research Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 9, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): August 15, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Estimate): January 19, 2023

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Physical functioning; Physiological Ketosis; PanTrek; Asthenia; Mental functioning; beta-oxibutiric acid
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis; Asthenia
• Other Study ID Numbers: KetonicPharm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No