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Clinical Trials/NCT03580447
NCT03580447
Completed
N/A

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

Maastricht University Medical Center1 site in 1 country37 target enrollmentSeptember 28, 2018
ConditionsElderly

Overview

Phase
N/A
Intervention
Not specified
Conditions
Elderly
Sponsor
Maastricht University Medical Center
Enrollment
37
Locations
1
Primary Endpoint
Oxidative stress
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2018
End Date
October 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yala Stevens

MSc.

Maastricht University Medical Center

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)

Outcomes

Primary Outcomes

Oxidative stress

Time Frame: Change from baseline to four weeks supplementation, of each intervention period

Oxidative stress, as measured by blood biomarkers

Study Sites (1)

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