The primary objective of this study is to determine the effect of daily supplementation of a combined orange- and pomegranate extract for a period of 4 weeks on physical fitness compared to placebo.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
fitheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoints are distance covered during a 6 minute walk test (6 MWT)
Secondary outcome
Secondary endpoints include the quality of life, as measured by the WHOQOL-BREF
questionnaire, lower body strength as measured by the 30s chair stand test,
upper body strenght as measured by an arm curl test, lower body flexibility as
measured by a chair sit and reach test, upper body flexibility as measured by a
back scatch test, heart rate (HR) in rest and during a 6 minute walk test,
daily physical activity measured with accelerometer, and blood parameters of
antioxidative capacity and inflammation.
Background summary
Dietary habits and physical activity are two important components of a healthy
lifestyle. Targeted nutritional interventions may improve health and stimulate
physical activity. Both orange extracts and pomegranate concentrate have been
shown to exert beneficial effects on health and exercise performance. However,
the effects of a combination of the two extracts on exercise and physical
activity have not been investigated yet. It is expected that this combination
may be an effective dietary way to improve exercise performance, physical
activity in the free-living state, and quality of life in a middle aged
population.
Study objective
The primary objective of this study is to determine the effect of daily
supplementation of a combined orange- and pomegranate extract for a period of 4
weeks on physical fitness compared to placebo.
Study design
The design conforms to a randomized, double-blind, placebo-controlled
cross-over design
Intervention
In this crossover study, participants will daily receive either a placebo or
Actiful®, a supplement containing 500 mg orange extract and 200 mg pomegranate
actives, for 4 weeks followed by a wash-out period of 4 to 8 weeks.
Subsequently, the second intervention period of 4 weeks (active product or
placebo) will take place. The product and placebo will be supplied in capsules
that participants can ingest with a glas of water (daily, prior to breakfast).
Study burden and risks
In total, participants will visit the site 5 times, (one screening, 4 test
days), resulting in a time investment of approximately 10 hours. During the
study participants will have to answer questionnaires about (general) health
status and Quality of Life, and have to undergo several tests to determine
physical fitness. Furthermore they will have to keep food and activity records
and wear an accelerometer the week prior to each test day. A maximum of 39.8
ml of blood will be collected each test day.
Oxfordlaan 70
Maastricht 6229EV
NL
Oxfordlaan 70
Maastricht 6229EV
NL
Listed location countries
Age
Inclusion criteria
Healthy male/female (based on medical history provided during a general health questionnaire); Age between 60 * 75
Exclusion criteria
- Allergy to test product/placebo
- Allergy to citrus fruits
- BMI lower than 18 or higher than 28
- Recent muscle injury in less than one month before the start of the study.
- Medical conditions that might influence outcome measure or participant safety during testing, including but not limited to: severe cardiovascular disease, cancer, Parkinson*s disease. To be decided by PI.
- High blood pressure (systolic * 140 mmHg, diastolic * 90 mmHg (40)
- Use of medication that may interfere with the study results
- Smoking
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
- Abuse of products; alcohol (> 20 alcoholic units per week) and drugs.
- Unable to correctly perform the tests during the familiarization test
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 | NL63326.068.17 |
| Other | volgt nog |