The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity: a Randomized Controlled Parallel Intervention Study in Healthy Overweight Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in endurance capacity
研究概览
简要总结
The aim of the present study is to investigate the effect of 12-week long daily administration of a sweet orange and pomegranate extract on exercise capacity in healthy adults.
详细描述
Background of the study: Polyphenols have been studied for their protective effect against the development of ROS-related diseases like cancers, cardiovascular diseases, diabetes, osteoporosis, and neurodegenerative diseases. The combined supplementation of pomegranate and sweet orange polyphenols could be an effective strategy to improve exercise performance, due to their antioxidant character and ability to stimulate NO production, to stimulate mitochondrial biogenesis and to accelerate muscle repair and decrease muscle tissue damage. The study aims to assess the effect of a combined supplementation of pomegranate and sweet orange extract on exercise capacity, physical activity, muscle strength and quality of life in healthy adults.
Objective of the study: The aim of the present study is to investigate the effect of 12-week long daily administration of a sweet orange and pomegranate extract on exercise capacity in healthy adults (40 - 65 y).
Study design: Randomized, double-blind, placebo-controlled parallel trial
Study population: Healthy, overweight, sedentary adults between 40 and 65 years old.
Intervention: 12-week supplementation with 650 mg sweet orange and pomegranate extract (2 capsules per day) compared to placebo (760 mg maltodextrin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male/female (based on medical history provided during a general health questionnaire)
- •Age between 40 - 65 yrs
- •Overweight (BMI ≥25 to ≤29.9 kg/m2)
- •Sedentary subjects (Low Level [<600 MET-minutes/week] as assessed by the Physical Activity Questionnaire (IPAQ))
排除标准
- •Allergy to test product/control or citrus fruits and pomegranate
- •Medical conditions that might interfere with endpoints or compromise participant safety during testing (e.g. Cardiovascular diseases, cancer, Parkinson's disease, Gastrointestinal diseases or abdominal surgery) to be decided by the principal investigator
- •Use of medication that might interfere with endpoints (i.e.: β-blockers, antioxidant, antidepressants)
- •High fasting blood glucose (FBG ≥100 mg/dL)
- •Recent skeletal muscle injury in less than one month before the start of the study
- •Use of antibiotics within 3 months prior to Visit 2
- •Use of probiotics or supplements containing vitamins, minerals or antioxidants four weeks prior to Visit 2
- •Regular smoking (including use of e-cigarettes)
- •Inability to correctly perform the PA test during screening/familiarization
- •Abuse of alcohol (alcohol consumption >20 units/week) and/or drugs
- •Plans to change diet or medication for the duration of the study
- •Treatment with an investigational drug (phase 1-3) 180 days before the start of the study
- •Inability to understand study information and/or communicate with staff
研究组 & 干预措施
Sweet orange and pomegranate extract
Supplementation
干预措施: Sweet orange and pomegranate extract (Dietary Supplement)
Maltodextrin
Supplementation
干预措施: Maltodextrin control (Other)
结局指标
主要结局
Change in endurance capacity
时间窗: 12 weeks
An Ekblom-bak cycling test is used to estimate the maximal oxygen consumption
次要结局
- Change in Muscle metabolism (marker Glut4)(12 weeks)
- Change in Muscle redox biology (marker GCLC)(12 weeks)
- Change in Muscle redox biology (marker Hmox1)(12 weeks)
- Change in Daily physical activity(12 weeks)
- Change in Handgrip strength(12 weeks)
- Change in Muscle mitochondrial biogenesis (marker PGC1alpha)(12 weeks)
- Change in Self reported quality of life(12 weeks)
- Change in General health(12 weeks)
- Change in Vitality(12 weeks)
- Change in Glucose levels(12 weeks)
- Change in Cholesterol levels(12 weeks)
- Change in Triglyceride levels(12 weeks)
- Change in Insulin levels(12 weeks)
- Change in Muscle proliferation (marker Pax7)(12 weeks)
- Change in Muscle differentiation (marker MyoD)(12 weeks)
- Change in Muscle differentiation (marker Myogenin)(12 weeks)
- Change in Muscle differentiation (marker Myosin Heavy Chain)(12 weeks)
- Change in Antioxidative capacity(12 weeks)
- Change in Cell elongation index(12 weeks)
- Change in Cortisol levels(12 weeks)
- Change in C-reactive protein levels(12 weeks)