The Effect of Citrus Extract on Oxidative Stress

NCT03580447 | Completed

• 1 other identifier: 183018
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Oxidative stress

  Oxidative stress, as measured by blood biomarkers

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

Study Arms (2)

Citrus extract

EXPERIMENTAL

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

Dietary Supplement: Citrus extract

Placebo

PLACEBO COMPARATOR

During this period participants receive daily maltodextrin supplements for four week

Dietary Supplement: Placebo

Interventions

Citrus extract DIETARY_SUPPLEMENT

Citrus extract

Citrus extract

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy individuals
• Age 70-85 years
• BMI \< 30 kg/m2

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Interventions

grapefruit seed extract

Study Officials

• Ad Masclee, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 9, 2018
• Study Start: September 28, 2018
• Primary Completion: September 30, 2019
• Study Completion: October 1, 2019
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)