HealthyNCT00545415
The Effect of Fruit and Fruit Juice on Plasma Total Antioxidant Capacity
A study testing Order 1, Order 2 and Order 3 in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The aim of the study is to compare the effect of consumption of a fruit beverage on plasma antioxidant capacity with that of the consumption of fruit. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Order 1, Order 2 and Order 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- body mass index between 20-25
Who cannot join
- use of any medication
- smoking
- consumption of 3 or more glasses of alcohol per day
- involved in top sport
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the effect of consumption of a fruit beverage on plasma antioxidant capacity with that of the consumption of fruit.
- Conditions
- Healthy
- Being tested
- Order 1, Order 2, Order 3, Order 4, Order 5
- Keywords
- fruit, antioxidant, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Order 1Dietary supplement
Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.
Order 2Dietary supplement
Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.
Order 3Dietary supplement
Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.
Order 4Dietary supplement
Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.
Order 5Dietary supplement
Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.
Order 6Dietary supplement
Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: Order 1 |
| 2 | Experimental | Not described Receives: Dietary Supplement: Order 2 |
| 3 | Experimental | Not described Receives: Dietary Supplement: Order 3 |
| 4 | Experimental | Not described Receives: Dietary Supplement: Order 4 |
| 5 | Experimental | Not described Receives: Dietary Supplement: Order 5 |
| 6 | Experimental | Not described Receives: Dietary Supplement: Order 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total plasma antioxidant capacity after intake of three different kinds of fruit(beverage)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Aalt Bast, Prof. Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545415
- Sponsor's protocol ID
- MEC-07-3-043
- Status last verified
- Jul 2009
- First submitted
- 11 Oct 2007
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fruit and Fruit Juice on Plasma Total Antioxidant Capacity
- ClinicalTrials.gov ID
- NCT00545415
- Acronym / sponsor ID
- MEC-07-3-043
- Conditions
- Healthy
- Keywords
- fruit, antioxidant, Healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the effect of consumption of a fruit beverage on plasma antioxidant capacity with that of the consumption of fruit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Order 1 |
| 2 | Experimental | Dietary Supplement: Order 2 |
| 3 | Experimental | Dietary Supplement: Order 3 |
| 4 | Experimental | Dietary Supplement: Order 4 |
| 5 | Experimental | Dietary Supplement: Order 5 |
| 6 | Experimental | Dietary Supplement: Order 6 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males
- body mass index between 20-25
Key exclusion criteria (4 listed)
- use of any medication
- smoking
- consumption of 3 or more glasses of alcohol per day
- involved in top sport
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Order 1Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands. Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out. | Dietary supplement | 1 |
| Order 2Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands. Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out. | Dietary supplement | 2 |
| Order 3Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands. Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out. | Dietary supplement | 3 |
| Order 4Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands. Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out. | Dietary supplement | 4 |
| Order 5Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands. Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out. | Dietary supplement | 5 |
| Order 6Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands. Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out. | Dietary supplement | 6 |
Primary outcome
The total plasma antioxidant capacity after intake of three different kinds of fruit(beverage)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aalt Bast, Prof. Dr. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Order 1, Order 2 and Order 3 in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total plasma antioxidant capacity after intake of three different kinds of fruit(beverage) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.