The Effect of Lemongrass on Aerobic Performance and Sexual Wellbeing Following High-Intensity Interval Training Training in Males
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Aerobic Capacity
研究概览
简要总结
The goal of this experimental study is to examine the influence of Lemongrass extract on aerobic training parameters following a 6-week training programme in males. A secondary aim will be to explore the influence on sexual wellness. Participants will attend 23 visits to the laboratory involving:
- fitness testing (some to exhaustion).
- blood sampling (capillary and venous samples).
- a supervised 6 week high-intensity interval training (HIIT) programme.
- consuming either the lemongrass extract or placebo in the form of tablets, once a day during the 6 week training.
详细描述
The study is a randomised, parallel (two groups, lemongrass versus placebo), double-blind, placebo-controlled design in males (25-60 years).
Visit 1: Pre-screening Participants will receive information on the study, be assessed for contraindications, be familiarised with the requirements for participation, and provide written informed consent.
Visit 2: Familiarisation with the dependent measures Study staff will review physical activity questionnaires, and if eligibility criteria are met, participants will enter the trial. Participants will refrain from physical activity and alcohol consumption for 24 hours, and caffeine for 12 hours before each visit. Next, participants will be familiarised with the equipment to be used during the study.
Following a resting capillary blood lactate sample, participants will perform an exercise session on a cycle ergometer, beginning with a 5-minute warm-up at a self-paced intensity equating to approximately 10 on the 6-20 Rating of Perceived Exertion (RPE) scale.
The session will then start with the participant cycling at 50 watts (W) for 4 minutes, with an increase of 30 W every 4 minutes, while blood lactate is taken and heart rate recorded in the last 30 seconds of each stage. Once blood lactate has reached the second inflection point, the test will be terminated. Throughout the exercise session, expired air will be measured using online gas analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 40 and ≤ 60 years.
- •Body Mass Index (BMI) ≥ 19 and ≤ 35 kg/m
- •Willingness and ability to comply with the protocol in the opinion of the Investigator.
- •Judged by the Investigator to be in good health as assessed by a health screening questionnaire.
- •Currently identifies as the same biological sex as at birth.
- •Currently deemed to be between a physical activity status of sedentaryy to moderately trained (Meet World Health Organization minimum activity guidelines: Adults aged 18-64 years old completing at least 150 to 300 min moderate-intensity activity or 75-150 min of vigorous-intensity activity a week, plus muscle-strengthening activities 2 or more days a week).
- •Have a blood pressure < 140/90 mmHg.
排除标准
- •A history of heart disease.
- •Any disease that might interfere with the absorption of nutrients (e.g. Chron's disease, celiac disease).
- •Recent musculoskeletal or soft tissue injury (within the last 3 months).
- •The habitual use of medication that is antihypertensive or antidiabetic medication or might inhibit the ability to complete the study participation.
- •Alcohol Intake of greater than 21 units per week.
- •A change in bodyweight of more than 3kg within the month preceding the study.
- •Currently following a weight-loss or weight-gain programme.
- •Any known bleeding disorder or reaction to withdrawal of blood samples
研究组 & 干预措施
Control: Placebo
Tablet containing microcrystalline cellulose.
干预措施: Control: Placebo (Dietary Supplement)
Active: Lemongrass Extract
Tablet containing 200mg Lemongrass extract (Mibelle).
干预措施: Active: Lemongrass (Dietary Supplement)
结局指标
主要结局
Aerobic Capacity
时间窗: This measure will assessed and measured twice: Baseline assessment: Visit 3 (Week 1, prior to the intervention). Post-intervention assessment: Visit 23 (Week 8, within 48 hours after the final training session).
To determine the effect of the intervention vs placebo on marker of aerobic capacity (VO2peak). It will be assessed using breath-by-breath gas analysis during a graded exercise protocol on a static bike. The test will start at the intensity immediately below the second inflection point identified on the lactate profile (conducted in visit 2). The intensity will increase by 30 w each minute until VO2peak which will be confirmed when at least one of the following criteria (according to CASES) are met: (1) a plateau in VO2 despite an increase in workload; (2) a respiratory exchange ratio (RER) higher than 1.15; (3) peak heart rate at least equal to 90% of the age-predicted maximum and/or (4) RPE of \>18; (5) a blood lactate concentration of \> 8mMol/L. Maximum aerobic power will be defined as the final completed work rate. This will be used for subsequent training prescription (125% of maximal aerobic power \[Pmax\]).
Aerobic Performance (blood lactate)
时间窗: This measure will be assessed three times. Familiarisation and lactate profiling: Visit 2 (Week 0). Baseline assessment: Visit 3 (Week 1, prior to the intervention), Post-intervention assessment: Visit 23 (Week 8, within 48 hrs after the final training).
To determine the effect of intervention vs placebo on secondary markers of maximal aerobic performance (blood lactate). A total of 14 (more if the submaximal exercise test progresses beyond 4 stages) capillary samples will be collected for each participant during the submaximal and graded exercise tests. This will be pre-exercise, then in the final minute of each ramped stage during the submaximal test. A final lactate sample will be collected upon completion of the VO2peak test. These samples will be analysed for lactate concentration immediately using a Biosen C-line analyser before being disposed of.
Aerobic Performance (heart rate)
时间窗: This measure will be assessed three times. Familiarisation and lactate profiling: Visit 2 (Week 0). Baseline assessment: Visit 3 (Week 1, prior to the intervention), Post-intervention assessment: Visit 23 (Week 8, within 48 hrs after the final training).
To determine the effect, if any, of intervention vs placebo on secondary markers of maximal aerobic performance (heart rate). Heart rate will be continuously monitored using a chest strap (Polar monitor) throughout the various exercise protocols (lactate profiling in visit 2 and 3, and the graded exercise task in visit 3 and 23).
次要结局
- Sexual Wellness(This measure will assessed and measured twice: Baseline assessment: Visit 3 (Week 1, prior to the intervention). Post-intervention assessment: Visit 23 (Week 8, within 48 hours after the final training session).)
- Serum(This measure will assessed and measured twice: Baseline assessment: Visit 3 (Week 1, prior to the intervention). Post-intervention assessment: Visit 23 (Week 8, within 48 hours after the final training session).)
研究者
Glyn Howatson
Professor
Northumbria University