The Effect of Citrus Extract on Oxidative Stress

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580447
• Other study ID #: 183018
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: October 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 1, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly

Intervention

Dietary Supplement:
• Citrus extract
Citrus extract
• Placebo
Maltodextrin

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative stress	Oxidative stress, as measured by blood biomarkers	Change from baseline to four weeks supplementation, of each intervention period