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The effect of citrus extract administration on markers of oxidative stress in elderly subjects

Completed
Conditions
eeftijdsgerelateerde gezondheidsafname, zoals o.a. verhoogd risico op infectie
Elderly
older individuals
Registration Number
NL-OMON45776
Lead Sponsor
niversiteit Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
44
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)
* 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 medication 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary objective is to assess the effect of 4 weeks of daily citrus<br /><br>extract supplementation on blood biomarkers of oxidative stress in elderly<br /><br>subjects. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The effect of 4 weeks of daily 500 mg citrus extract supplementation on blood<br /><br>markers of inflammation.<br /><br>The effect of daily citrus extract supplementation 500m on fecal markers of<br /><br>intestinal inflammation and immune function after 4 weeks of administration.<br /><br>The effect of 500 mg citrus extract on fecal and oral microbiota composition<br /><br>and metabolic activity after 4 weeks of administration.<br /><br>The effect of 500 mg citrus extract on stool frequency, stool consistency and<br /><br>GI complaints after 4 weeks of administration.</p><br>
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