The Effect of Citrus Extract on Oxidative Stress | NCT03580447

NCT03580447

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Citrus extract	Experimental	During this period participants receive daily citrus extract supplements for four weeks	Dietary Supplement: Citrus extract
Placebo	Placebo Comparator	During this period participants receive daily maltodextrin supplements for four week	Dietary Supplement: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Citrus extract	Dietary Supplement	Citrus extract	Citrus extract
Placebo

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

Eligibility Module

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