Elderly
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCitrus extract
Citrus extract
DIETARY_SUPPLEMENTPlacebo
Maltodextrin
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative stress | Change from baseline to four weeks supplementation, of each intervention period | Oxidative stress, as measured by blood biomarkers |
Countries
Netherlands
Outcome results
None listed