The Effect of Citrus Extract on Oxidative Stress

NCT ID: NCT03580447

Last Updated: 2019-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-28
• Study Completion Date: 2019-10-01

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.

Conditions

Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Citrus extract

During this period participants receive daily citrus extract supplements for four weeks

Group Type: EXPERIMENTAL

Citrus extract

Intervention Type: DIETARY_SUPPLEMENT

Citrus extract

Placebo

During this period participants receive daily maltodextrin supplements for four week

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

Interventions

Citrus extract

Citrus extract

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

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)
• 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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yala Stevens

MSc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ad Masclee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

183018

Identifier Type: -

Identifier Source: org_study_id