Novel Energy Metabolic Signaling Molecule With Therapeutic Potential

Study Overview
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Brief Summary
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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
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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 Altogether 5 arterial blood samples were withdrawn.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.

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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Panavital
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy 50-60 year-old females and males Exclusion Criteria: history of cardiovascular diseases, overweight (BMI >32)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* 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.<br>|
| Active Comparator: RH013001 (DGA)<br>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<br>* 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.<br>* Other names: D-glyceric acid calcium salt dehydrate;|

What is the study measuring?
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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 |