The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity in Middle-aged Adults
- Conditions
- Exercise Capacity
- Interventions
- Dietary Supplement: Sweet orange and pomegranate extractOther: Maltodextrin control
- Registration Number
- NCT05133778
- Lead Sponsor
- Maastricht University
- Brief Summary
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.
- Detailed Description
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).
Primary outcome of the study: Change in aerobic capacity (VO2max), assessed with an Ekblom-Bak submaximal cycling test.
Secondary study parameters/outcome of the study:
* Daily physical activity as determined by accelerometer
* Dietary intake as measured by a 3-day food record
* Handgrip strength
* Muscle cell proliferation and differentiation and mitochondrial biogenesis assessed in skeletal muscle biopsies
* Quality of Life as measured by the WHO-QOL-100 questionnaire
* General health as measured by SF-36 questionnaire
* Vitality as measured by the Dutch Vitality Questionnaire (Vita-16)
* Cardiometabolic health biomarkers, cortisol, C-reactive protein determined with ELISA
* Antioxidative capacity measured with a Trolox equivalent antioxidant capacity (TEAC) assay
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 52
- 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))
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sweet orange and pomegranate extract Sweet orange and pomegranate extract Supplementation Maltodextrin Maltodextrin control Supplementation
- Primary Outcome Measures
Name Time Method Change in endurance capacity 12 weeks An Ekblom-bak cycling test is used to estimate the maximal oxygen consumption
- Secondary Outcome Measures
Name Time Method Change in Daily physical activity 12 weeks Measured with an accelerometer
Change in Handgrip strength 12 weeks Measured with a dynamometer
Change in Self reported quality of life 12 weeks Measured with the World Health Organization Quality of Life (WHO-QOL-100) questionnaire. For 6 domains (including physical, psychological, level of independence, social relationships, environment and religion/personal beliefs), a score will be calculated between 2 - 40 in which a higher score indicates better quality of life.
Change in General health 12 weeks Measured with the 36-Item Short Form Health Survey. For 4 domains (including functional status, wellbeing, general health and change in health), a score will be calculated between 0 - 100 in which a higher score indicates better health.
Change in Vitality 12 weeks Measured with the vita-16 questionnaire. For 4 domains (including energy, motivation, resilience and overall vitality), a score will be calculated between 1 - 7 in which a higher score indicates higher vitality.
Change in Glucose levels 12 weeks Measured in blood samples
Change in Cholesterol levels 12 weeks Measured in blood samples
Change in Triglyceride levels 12 weeks Measured in blood samples
Change in Insulin levels 12 weeks Measured in blood samples
Change in Muscle proliferation (marker Pax7) 12 weeks Measured with qPCR in muscle tissue samples
Change in Muscle differentiation (marker MyoD) 12 weeks Measured with qPCR in muscle tissue samples
Change in Muscle differentiation (marker Myogenin) 12 weeks Measured with qPCR in muscle tissue samples
Change in Muscle differentiation (marker Myosin Heavy Chain) 12 weeks Measured with qPCR in muscle tissue samples
Change in Muscle mitochondrial biogenesis (marker PGC1alpha) 12 weeks Measured with qPCR in muscle tissue samples
Change in Muscle metabolism (marker Glut4) 12 weeks Measured with qPCR in muscle tissue samples
Change in Muscle redox biology (marker GCLC) 12 weeks Measured with qPCR in muscle tissue samples
Change in Muscle redox biology (marker Hmox1) 12 weeks Measured with qPCR in muscle tissue samples
Change in Antioxidative capacity 12 weeks Measured with a TEAC assay in blood
Change in Cell elongation index 12 weeks Measured with immunohistochemistry in muscle tissue samples
Change in Cortisol levels 12 weeks Measured in blood samples
Change in C-reactive protein levels 12 weeks Measured in blood samples
Trial Locations
- Locations (1)
Maastricht University
🇳🇱Maastricht, Netherlands