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The Effect of Citrus Extract on Oxidative Stress

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Elderly

Treatments

Dietary Supplement: Citrus extract
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

70 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

37 participants in 2 patient groups, including a placebo group

Citrus extract
Experimental group
Description:
During this period participants receive daily citrus extract supplements for four weeks
Treatment:
Dietary Supplement: Citrus extract
Placebo
Placebo Comparator group
Description:
During this period participants receive daily maltodextrin supplements for four week
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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