Novel Energy Metabolic Signaling Molecule With Therapeutic Potential
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Healthy Participants
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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).Masking: Double (Participant, Care Provider)Masking Description: Participants and care providers were fully blinded.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 60 years
- Gender
- Both males and females
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 ...
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 Altogether 5 arterial blood samples were withdrawn.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.
Tracking Information
- NCT #
- NCT04713319
- Collaborators
- 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
Get Well Soon