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).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
physical fitness
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in aerobic capacity (VO2max), assessed with an Eklom-Bak submaximal
cycling test.
Secondary outcome
- Daily physical activity as determined by accelerometer
- Dietary intake as measured by a 3-day food record
- Muscle strength as measured by 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
Background summary
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 decreasing 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.
Study objective
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
Intervention
12-week supplementation with 650 mg sweet orange and pomgranate extract (2
capsules per day) compared to placebo (760 mg maltodextrin).
Study burden and risks
In a period of 14 weeks, participants will attend five test days, resulting in
a time investment of approximately 6.5 hours in total. Furthermore,
participants have the possibility to take part in the sub-study, in which two
more study days will be performed with a time investment of 45 minutes each.
During the study, participants will perform a sub-maximal cycling test which
might lead to tiredness and muscle soreness. Blood samples will be taken, which
might lead to minor discomfort and could cause small and transitory
hematoma/bruises to appear. Participants will be asked to wear an accelerometer
twice for a period of 7 days and to fill in a 3-day food record on three
occasions. The muscle biopsy could cause local hematoma and after the biopsy,
some participants may report muscle muscle stiffness or pain for a couple of
days.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77699.068.21 |