ElderlyNCT03580447
The Effect of Citrus Extract on Oxidative Stress
A study testing Citrus extract in people with Elderly, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This randomized, cross-over, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 4 weeks on markers of oxidative stress in elderly. Read more about this study
- Who is it for?
- Ages 70 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Citrus extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Sep 2018to 1 Oct 2019
- 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 70 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy individuals
- Age 70-85 years
- BMI < 30 kg/m2
Who cannot join
- History or actual status of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Disease with a life expectancy shorter than 5 years
- Institutionalized (e.g. hospital or nursing home).
- Subjects with abnormalities in haematology which may interfere with the endpoints of the study (to be decided by the principle investigator)
- Use of drugs or hormones within 3 months prior to the start of the study which may interfere with the endpoints of the study (to be decided by the principle investigator)
- Self-admitted Inflammation, (viral) infection (e.g. HIV or hepatitis B)
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- Subjects with an autoimmune disease (e.g. Rheumatoid arthritis)
- Subjects with intestinal disorders which may interfere with the endpoints of the study (to be decided by the principle investigator)
- Use of immunosuppressive drugs within 3 months prior to the start of the study
- Use of medication (e.g. NSAIDs), antibiotics or corticosteroids which may interfere with the endpoints of the study (to be decided by the principle investigator)
- Changes in medication that may significantly affect the study outcome (according to the investigator's judgment) within 1 month prior to the start of the study.
- Use 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 before the study
- Use of (dietary) supplements containing antioxidants, vitamins and minerals
- Smoking
- Weight gain or loss (> 3 kg in the previous 3 months)
- Excessive intake of foods with a high polyphenol concentration
- Use of pre-, pro or synbiotics within 1 month prior to the start of the study
- Blood donation within 1 month prior to the start of the study
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
- History of any side effects towards the intake of flavonoids or citrus fruits
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: The Effect of Citrus Extract Administration on Markers of Oxidative Stress in Elderly Subjects
This randomized, cross-over, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 4 weeks on markers of oxidative stress in elderly.
- Conditions
- Elderly
- Being tested
- Citrus extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrus extractDietary supplement
Citrus extract
PlaceboDietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Citrus extract | Experimental | During this period participants receive daily citrus extract supplements for four weeks Receives: Dietary Supplement: Citrus extract |
| Placebo | Placebo comparator | During this period participants receive daily maltodextrin supplements for four week Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress
Oxidative stress, as measured by blood biomarkers
Measured: Change from baseline to four weeks supplementation, of each intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start28 Sep 2018
- Primary completion30 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yala Stevens, Maastricht University Medical Center
- Investigators
- Ad Masclee, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580447
- Sponsor's protocol ID
- 183018
- Status last verified
- Oct 2019
- First submitted
- 26 Jun 2018
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Citrus Extract Administration on Markers of Oxidative Stress in Elderly Subjects
- ClinicalTrials.gov ID
- NCT03580447
- Acronym / sponsor ID
- 183018
- Conditions
- Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 9 Jul 2018 (actual)
- 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.
This randomized, cross-over, double-blind, placebo-controlled trial aims to determine the effects of daily administration of citrus extract over a period of 4 weeks on markers of oxidative stress in elderly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citrus extract | Experimental | Dietary Supplement: Citrus extractDuring this period participants receive daily citrus extract supplements for four weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDuring this period participants receive daily maltodextrin supplements for four week |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Healthy individuals
- Age 70-85 years
- BMI < 30 kg/m2
Key exclusion criteria (20 listed)
- History or actual status of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Disease with a life expectancy shorter than 5 years
- Institutionalized (e.g. hospital or nursing home).
- Subjects with abnormalities in haematology which may interfere with the endpoints of the study (to be decided by the principle investigator)
- Use of drugs or hormones within 3 months prior to the start of the study which may interfere with the endpoints of the study (to be decided by the principle investigator)
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 |
|---|---|---|
| Citrus extractCitrus extract | Dietary supplement | Citrus extract |
| PlaceboMaltodextrin | Dietary supplement | Placebo |
Primary outcome
Oxidative stress
Time frame: Change from baseline to four weeks supplementation, of each intervention period
Oxidative stress, as measured by blood biomarkers
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 28 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Ad Masclee, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrus extract in people with Elderly, 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 3 inclusion and 20 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 28 Oct 2019. 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. Some participants in this study may receive a placebo. 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?
Oxidative stress (time frame: Change from baseline to four weeks supplementation, of each intervention period). 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 28 Oct 2019.