The Effect of Citrus Extract on Oxidative Stress

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

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.

Study Overview

• Status: Completed
• Conditions: Elderly
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Citrus extract

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Citrus extract; During this period participants receive daily citrus extract supplements for four weeks	Dietary supplement: Citrus extract; Citrus extract
Placebo Comparator: Placebo; During this period participants receive daily maltodextrin supplements for four week	Dietary supplement: Placebo; Maltodextrin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 183018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No