Clinical trial NCT03580447: The Effect of Citrus Extract on Oxidative Stress
Official title: The Effect of Citrus Extract Administration on Markers of Oxidative Stress in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 37
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Age 70-85 years
* BMI \< 30 kg/m2

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Oxidative stress
timeFrame: Change from baseline to four weeks supplementation, of each intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Ad Masclee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: