Skip to main content
OpenTrials
Completed

NCT Number: NCT04713319

Novel Energy Metabolic Signaling Molecule With Therapeutic Potential

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Sports and Health Sciences, University of Jyväskylä

Jyväskylä, Central Finland, FI-40014, Finland

About this study

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 Altogether 5 arterial blood samples were withdrawn.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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy 50-60 year-old females and males

Exclusion criteria

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

Treatment and study plan

Panavital

Drug

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 names: D-glyceric acid calcium salt dehydrate

Placebo

Other

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.

Primary outcomes

  1. Acute change in blood IL-6, insulin, and glucose after RH013001 or Placebo dose at Day7

    Time frame: 45 minutes control blood sample

    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).

  2. Change in blood metrices from Day1 (0-control / baseline) to Day7

    Time frame: 7 days

    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

Secondary outcomes

  1. Global RNA-sequencing

    Time frame: 21 days

    From 3 "non-acute" blood samples (Day1, Day7 and Day21) white blood cells collected into Paxgene tubes.

  2. Change in "non-acute" blood sample metrices from Day1 (baseline) to Day21

    Time frame: 21 days

    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.

Other outcomes

  1. Participants' Aerobic Capacity at Day1.

    Time frame: 10-20 + 30 minutes

    Result of the indirect maximal oxygen intake VO2max test with cycling ergometer.

Sponsors and collaborators

Lead sponsor

Petteri Hirvonen

Industry

Collaborators

  • University of Jyvaskyla

Registry information

Official study title

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

Acronym: RH013001

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2021
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.