The Effect of Citrus Extract on Oxidative Stress

Not Applicable

Completed

• Conditions: Elderly
• Interventions: Dietary Supplement: Citrus extract; Dietary Supplement: Placebo

• Registration Number: NCT03580447
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-09
• Study Start: 2018-09-28
• Primary Completion: 2019-09-30
• Status Verified: 2019-10
• Study Completion: 2019-10-01
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Citrus extract	Citrus extract	During this period participants receive daily citrus extract supplements for four weeks
Placebo	Placebo	During this period participants receive daily maltodextrin supplements for four week

Primary Outcome Measures

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

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands