Clinical trial NCT04713319: Novel Energy Metabolic Signaling Molecule With Therapeutic Potential
Official title: Acute Health Effects of a Bout of Exercise in Physically Active Persons and Comparison to a Repetition With Natural Signalling Agent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Participants
Lead sponsor: Replicon Health Oy
Sponsor class: INDUSTRY
Collaborators: name: University of Jyvaskyla
First posted: 2021-01-19
Enrollment: 27
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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).

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 Altogether 5 arterial blood samples were withdrawn.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.

Eligibility criteria: Inclusion Criteria:

* healthy 50-60 year-old females and males

Exclusion Criteria:

* history of cardiovascular diseases, overweight (BMI \>32)

Primary outcomes:
measure: Acute change in blood IL-6, insulin, and glucose after RH013001 or Placebo dose at Day7
timeFrame: 45 minutes control blood sample
measure: Change in blood metrices from Day1 (0-control / baseline) to Day7
timeFrame: 7 days
Secondary outcomes:
measure: Global RNA-sequencing
timeFrame: 21 days
measure: Change in "non-acute" blood sample metrices from Day1 (baseline) to Day21
timeFrame: 21 days
Other outcomes:
measure: Participants' Aerobic Capacity at Day1.
timeFrame: 10-20 + 30 minutes
Locations:
city: Jyväskylä
country: Finland
facility: Faculty of Sports and Health Sciences, University of Jyväskylä
state: Keski-Suomi
Study officials:
affiliation: University of Jyvaskyla
name: Heikki Kyröläinen, PhD
role: STUDY_DIRECTOR
affiliation: University of Jyväskylä, Replicon Health Oy
name: Petteri Hirvonen, M.Sc., MBA
role: PRINCIPAL_INVESTIGATOR
References: