Novel Energy Metabolic Signaling Molecule With Therapeutic Potential (RH013001)

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Other: Placebo; Drug: Panavital

Detailed 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 Altogether 5 arterial blood samples were withdrawn.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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Finland
  • Keski-Suomi
    • Jyväskylä, Keski-Suomi, Finland, FI-40014
      • Faculty of Sports and Health Sciences, University of Jyväskylä

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy 50-60 year-old females and males

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Ten participants were randomly selected to the placebo group. Calcium chloride (E509) dissolved into water. Extremely small equimolar calcium dose with the test item.	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.
ACTIVE_COMPARATOR: RH013001 (DGA); D-glyceric acid (DGA) calcium salt dehydrate (RH013001) dissolved into 1.8 dl of water. Effective dose of DGA was 3.33 mg / kg body weigh for the first 4 days. Thereafter the dose was reduced to half for the 14 days follow up period. Frequency: 2 times a day.	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 Names: D-glyceric acid calcium salt dehydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global RNA-sequencing	From 3 "non-acute" blood samples (Day1, Day7 and Day21) white blood cells collected into Paxgene tubes.	21 days
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' Aerobic Capacity at Day1.	Result of the indirect maximal oxygen intake VO2max test with cycling ergometer.	10-20 + 30 minutes

Collaborators and Investigators

• Sponsor: Petteri Hirvonen
• Collaborators: University of Jyvaskyla
• Investigators: Study Director: Heikki Kyröläinen, PhD, University of Jyväskylä; Principal Investigator: Petteri Hirvonen, M.Sc., MBA, University of Jyväskylä, Replicon Health Oy

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 4, 2019
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (ACTUAL): January 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 2019_410211_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After deindentification of the individual data, we may share all the data that is reported in published articles. TIME FRAME: from 9 months to 36 months of the publication date. (Main data will be presented in the supplements of the articles.) Original Study Protocol and Study Plan for the Ethical Committee may also be shared. TO WHOM: researches who have been accepted by independent review committee for this purpose.

Drug and device information, study documents

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