Novel Energy Metabolic Signaling Molecule With Therapeutic Potential

Healthy Participants Clinical Trial

— RH013001  

Official title:

Acute Health Effects of a Bout of Exercise in Physically Active Persons and Comparison to a Repetition With Natural Signalling Agent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04713319
• Other study ID #: 2019_410211_2020
• Status: Completed
• Phase: Early Phase 1
• Start date: October 4, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2022
• Source: Replicon Health Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Altogether a 25-day study. First 4 days non-blinded with water before 0-control blood samples (Day0). Thereafter blinded for 21 days (3 weeks). Study group was apparently healthy 50-60 -year-old males and females (N=27).

Description:

Blinded 21-day period was divided into two sub-periods (7 days and 14 days) and it included 3 measurement days. All measurements were on the same day of each week to facilitate maximal comparability (Day0, Day7 and Day21). Additionally on Day0 and Day7 there were acute measurements 45 minutes after morning "non-acute" resting and fasting blood samples. (In a "non-acute" measurement last dose of Panavital or placebo was taken 12 hours before the "non-acute" blood sample collected next morning .) First week started with Day0 baseline measurements and immediately thereafter a strenuous VO2max test with 2 recovery days thereafter. After full recovery a 4-day blinded Panavital regimen. Last "non-acute" dose on Day6 was taken 12 hours before Day7 morning blood sample. At Day7 an acute 45 min placebo comparison was conducted. Thereafter a 14-day follow-up period with halved Panavital dose or Placebo. Altogether 5 arterial blood samples were withdrawn. Three fasting and resting "non-acute" samples were taken in the morning before any treatments at Day0, Day7 and Day21. Two acute samples were collected after the VO2max (Day1) and after acute Panavital or placebo doses (Day7). Additionally 5 fingertip blood samples for glucose (and lactate) were taken at the same time as arterial samples (Day0 and Day7) and one fingertip sample was taken immediately at the end of VO2max.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy 50-60 year-old females and males

Exclusion Criteria:

• history of cardiovascular diseases, overweight (BMI >32)

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Panavital
In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.

Other:
• Placebo
In the morning and evening a dose of Placebo or D-glyceric acid (DGA) calcium salt dehydrate (Panavital) dissolved into 1.8 dl of water.

Locations

Country	Name	City	State
Finland	Faculty of Sports and Health Sciences, University of Jyväskylä	Jyväskylä	Keski-Suomi

Sponsors (2)

Lead Sponsor	Collaborator
Petteri Hirvonen	University of Jyvaskyla

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants' Aerobic Capacity at Day1.	Result of the indirect maximal oxygen intake VO2max test with cycling ergometer.	10-20 + 30 minutes
Primary	Acute change in blood IL-6, insulin, and glucose after RH013001 or Placebo dose at Day7	Immediately after morning (non-acute) blood sample therapeutic dose of RH013001 or placebo. Comparison of average response between RH013001 and placebo. Additional comparison to VO2max response (see pre-specified outcome below).	45 minutes control blood sample
Primary	Change in blood metrices from Day1 (0-control / baseline) to Day7	Last dose 12 hours earlier = "non-acute". Paired comparison to Day1, measurements included energy metabolic and anti-inflammatory markers (first 3 days for recovery from VO2max), N in blinded placebo group was 0 for the first 7 days	7 days
Secondary	Global RNA-sequencing	From 3 "non-acute" blood samples (Day1, Day7 and Day21) white blood cells collected into Paxgene tubes.	21 days
Secondary	Change in "non-acute" blood sample metrices from Day1 (baseline) to Day21	Intra-group paired comparison to Day1 (paired t-test of the group averages), unpaired comparison of changes in group averages between placebo and RH013001 treatment.	21 days