Dose-Response Impact of Glucosyl-Hesperidin (CitraPeak) on Exercise Performance, Blood Flow, Stress, Cognition, and Other Perceptual Indicators
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline in Peak VO2 at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
研究概览
简要总结
The purpose of this study is to evaluate the dose-dependent effects of glucosyl-hesperidin (CITRAPEAK) supplementation on exercise performance, recovery indicators, blood flow, cognitive function, mood, sleep, and fuel utilization in recreationally active adults.
详细描述
This randomized, double-blind, placebo-controlled study investigates the effects of glucosyl-hesperidin (CITRAPEAK) on exercise performance, recovery, cognitive function, mood, and cardiovascular health in approximately 60 healthy, recreationally active adults aged 18-50. Participants will be assigned to one of three groups (placebo, 200mg CITRAPEAK, or 400mg CITRAPEAK) based on sex and baseline fat-free mass. Each participant will consume their assigned supplement daily for 8 weeks, with adherence tracked via supplementation logs. The study includes multiple visits, where participants will undergo a range of assessments, including exercise performance tests, blood flow analysis, and cognitive evaluations.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study employs a double-blind design to ensure that participants, investigators, and outcome assessors remain unaware of the group assignments. All supplements (placebo and both doses of CITRAPEAK®) are provided in identical capsules, containing either 400 mg of cellulose (placebo), 200 mg of CITRAPEAK® with 200 mg of cellulose, or 400 mg of CITRAPEAK®. Each participant is assigned a unique randomization code, which is used to label the capsules, maintaining blinding throughout the study. Only the study designated unblinded personnel have access to the randomization key, ensuring that the blinding remains intact for all other study staff.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are between 18 - 50 years of age
- •Body mass index values will range from >25.0 < 30.0 kg/m2
- •The average body mass index for entire study cohort will be less than 27.0 kg/m
- •As such an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 27.0 kg/m2
- •Free-living and independent
- •In good health absent of being overweight or mildly obese with no other signs or symptoms of cardiovascular, respiratory, metabolic, immune, psychiatric, or musculoskeletal disease or disorders
- •Willingness to maintain consistent sleep duration the evening before study visits
- •Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures
- •Regular completion of at least 180 minutes of moderate to vigorous exercise per week for the past 6 months
排除标准
- •Not currently completing at least 180 minutes of moderate to vigorous exercise per week for the past 6 months
- •Positive medical history and/or is currently being treated for some form of heart disease, cardiovascular disease
- •Currently being treated for kidney disease, renal failure, or has dialysis performed on regular intervals
- •Has liver disease or some form of clinically diagnosed hepatic impairment
- •Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
- •Diagnosed with or is being treated for some form of thyroid disease
- •Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year
- •Diagnosed with some form of immune disorder (i.e., HIV/AIDS)
- •History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
- •Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)
- •Positive medical history for any neurological condition or neurological disease
- •Currently prescribed a statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha blockers, Vasodilators, etc.)
- •Current smoker (average of > 1 pack per day within the past 3 months) has quit within the past six months. This includes all forms of nicotine
- •Intake of any drugs (prescribed or over the counter) or dietary supplements that are known or are purported to weight loss such as thermogenics, hydroxycitric acid, ephedra, capsaicin, etc.
- •Participants who are lactating, pregnant or planning to become pregnant
- •Have a known sensitivity or allergy to any of the study products
- •History of alcohol or substance abuse in the 12 months prior to screening
- •Receipt or use of an investigational product in another research study within 30 days of beginning the study protocol
- •Any orthopedic limitation that would prevent participation in a general fitness program
- •Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
结局指标
主要结局
Change from Baseline in Peak VO2 at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
时间窗: Baseline and Week 8
Peak VO2 will be measured as an indicator of maximal aerobic capacity. Higher values reflect improved cardiovascular performance.
Change from Baseline in Wingate Anaerobic Test Peak Anaerobic Power at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
时间窗: Baseline and Week 8
Peak anaerobic power will be measured to assess maximal power output during high-intensity exercise. Higher values indicate improved anaerobic performance.
Change from Baseline in Wingate Anaerobic Test Mean Anaerobic Power at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
时间窗: Baseline and Week 8
Wingate Anaerobic Test Mean anaerobic power will be recorded during repeated high-intensity exercise, with higher values indicating enhanced anaerobic endurance.
Change from Baseline in Fatigue Rate at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
时间窗: Baseline and Week 8
Wingate Anaerobic Test Fatigue rate will be measured as the decline in power over time during anaerobic exercise, with a lower rate indicating improved endurance.
Change from Baseline in Perceived Indicators of Recovery, Training Readiness, Soreness, and Overall Feel Using Visual Analog Scales (VAS) at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation
时间窗: Baseline and Week 8
Perceived recovery, training readiness, soreness, recovery, and general "feel" will be self-rated using visual analog scales (VAS), with higher values indicating greater perceived improvements in each category.
Change from Baseline in Brachial Artery Blood Flow Measured 0, 30, and 60 Minutes After Acute and Prolonged Ingestion of Glucosyl-Hesperidin (CITRAPEAK)
时间窗: Baseline and Week 8, measured at 0, 30, and 60 minutes post-ingestion.
Brachial artery blood flow will be measured to assess vascular response to CITRAPEAK at baseline and after 8 weeks of supplementation, with measurements taken at 0, 30, and 60 minutes post-ingestion.
次要结局
- Change from Baseline in Carbohydrate and Fat Oxidation Rates at 30%, 40%, 50%, 60%, 70%, and 80% Peak VO2 During Exercise at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation(Baseline and Week 8)
- Change from Baseline in Stroop Color Matching Test Performance 0, 30, and 60 Minutes After Ingesting Dose 1 (Week 0) and Dose 56 (Week 8) Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation(0, 30, and 60 minutes post-ingestion at baseline and Week 8)
- Change from Baseline in Trail Making Test Performance 0, 30, and 60 Minutes After Ingesting Dose 1 (Week 0) and Dose 56 (Week 8) Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation(0, 30, and 60 minutes post-ingestion at baseline and Week 8)
- Change from Baseline in Profile of Mood States (POMS) Score at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation(Baseline and Week 8)
- Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation(Baseline and Week 8)
- Change from Baseline in Plasma Nitric Oxide Levels at Week 8 Following Glucosyl-Hesperidin (CITRAPEAK) Supplementation(Baseline and Week 8)