The Effect of Citrus Extract on Oxidative Stress

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Citrus Extract Administration on Markers of Oxidative Stress in Elderly Subjects

Conditions
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Elderly

Intervention / Treatment
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* Dietary Supplement: Citrus extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citrus extract<br>During this period participants receive daily citrus extract supplements for four weeks | Dietary Supplement: Citrus extract<br>* Citrus extract<br>|
| Placebo Comparator: Placebo<br>During this period participants receive daily maltodextrin supplements for four week | Dietary Supplement: Placebo<br>* Maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress | Oxidative stress, as measured by blood biomarkers | Change from baseline to four weeks supplementation, of each intervention period |