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RH013001: Novel Energy Metabolic Signaling Molecule With Therapeutic Potential

Sponsor
Petteri Hirvonen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04713319
Collaborator
University of Jyvaskyla (Other)
27
Enrollment
1
Location
2
Arms
26.9
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Altogether 5 arterial blood samples were withdrawn.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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Altogether a 25 day study with first four days non-blinded with water. There after 0-control blood samples. After the 0-control blinded treatments for 21 days (3 weeks). Study group apparently healthy 50-60 year old males and females (N=27).Altogether a 25 day study with first four days non-blinded with water. There after 0-control blood samples. After the 0-control blinded treatments for 21 days (3 weeks). Study group apparently healthy 50-60 year old males and females (N=27).
Masking:
Double (Participant, Care Provider)
Masking Description:
Participants and care providers were fully blinded.
Primary Purpose:
Treatment
Official Title:
Acute Health Effects of a Bout of Exercise in Physically Active Persons and Comparison to a Repetition With Natural Signalling Agent
Actual Study Start Date :
Oct 4, 2019
Actual Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    1. Global RNA-sequencing [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 [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 Outcome Measures

    1. Participants' Aerobic Capacity at Day1. [10-20 + 30 minutes]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • healthy 50-60 year-old females and males
    Exclusion Criteria:
    • history of cardiovascular diseases, overweight (BMI >32)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Sports and Health Sciences, University of Jyväskylä Jyväskylä Keski-Suomi Finland FI-40014

    Sponsors and Collaborators

    • Petteri Hirvonen
    • University of Jyvaskyla

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Petteri Hirvonen, Chief Scientific Officer, Replicon Health Oy
    ClinicalTrials.gov Identifier:
    NCT04713319
    Other Study ID Numbers:
    • 2019_410211_2020
    First Posted:
    Jan 19, 2021
    Last Update Posted:
    Oct 22, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Calcium

    Study Results

    No Results Posted as of Oct 22, 2021