Acute Health Effects of a Bout of Exercise in Physically Active Persons and Comparison to a Repetition With Natural Signalling Agent
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Acute change in blood IL-6, insulin, and glucose after RH013001 or Placebo dose at Day7
研究概览
简要总结
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).
详细描述
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 Altogether 5 arterial blood samples were withdrawn.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants and care providers were fully blinded.
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy 50-60 year-old females and males
排除标准
- •history of cardiovascular diseases, overweight (BMI >32)
研究组 & 干预措施
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.
干预措施: Placebo (Other)
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.
干预措施: Panavital (Drug)
结局指标
主要结局
Acute change in blood IL-6, insulin, and glucose after RH013001 or Placebo dose at Day7
时间窗: 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).
Change in blood metrices from Day1 (0-control / baseline) to Day7
时间窗: 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
次要结局
- Global RNA-sequencing(21 days)
- Change in "non-acute" blood sample metrices from Day1 (baseline) to Day21(21 days)
研究者
Petteri Hirvonen
Chief Scientific Officer
Replicon Health Oy