The effect of sweet orange and pomegranate extract supplementation on exercise capacity: a randomized controlled parallel intervention study in healthy overweight individuals

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

- 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)
- Inactive subjects (<600 MET minutes of structured aerobic exercise per week
as assessed by the Physical Activity Questionnaire (IPAQ))

Exclusion Criteria

- 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 >=126 mg/dL)
- Recent skeletal muscle injury in less than one month before the start of the
study
- Use of antibiotics within 3 months prior 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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in aerobic capacity (VO2max), assessed with an Eklom-Bak submaximal<br /><br>cycling test. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Daily physical activity as determined by accelerometer<br /><br>- Dietary intake as measured by a 3-day food record<br /><br>- Muscle strength as measured by Handgrip strength<br /><br>- Muscle cell proliferation and differentiation and mitochondrial biogenesis<br /><br>assessed in skeletal muscle biopsies<br /><br>- Quality of Life as measured by the WHO-QOL-100 questionnaire<br /><br>- General health as measured by SF-36 questionnaire<br /><br>- Vitality as measured by the Dutch Vitality Questionnaire (Vita-16)<br /><br>- Cardiometabolic health biomarkers, cortisol, C-reactive protein determined<br /><br>with ELISA<br /><br>- Antioxidative capacity measured with a Trolox equivalent antioxidant<br /><br>capacity (TEAC) assay</p><br>