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Completed

NCT Number: NCT03580447

The Effect of Citrus Extract on Oxidative Stress

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.

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Key information

Conditions

Age range

70 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

citrus extract

Dietary Supplement

Citrus extract

Placebo

Dietary Supplement

Maltodextrin

Primary outcomes

  1. Oxidative stress

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

    Oxidative stress, as measured by blood biomarkers

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2018
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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