The aim of this study is to investigate the effect of citrus extract supplementation on markers of oxidative stress in elderly.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Leeftijdsgerelateerde gezondheidsafname, zoals o.a. verhoogd risico op infectie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to assess the effect of 4 weeks of daily citrus
extract supplementation on blood biomarkers of oxidative stress in elderly
subjects.
Secondary outcome
The effect of 4 weeks of daily 500 mg citrus extract supplementation on blood
markers of inflammation.
The effect of daily citrus extract supplementation 500m on fecal markers of
intestinal inflammation and immune function after 4 weeks of administration.
The effect of 500 mg citrus extract on fecal and oral microbiota composition
and metabolic activity after 4 weeks of administration.
The effect of 500 mg citrus extract on stool frequency, stool consistency and
GI complaints after 4 weeks of administration.
Background summary
Flavonoids are polyphenolic compounds with diverse beneficial biochemical
effects, including anti-oxidative and immune-modulating activities.
Furthermore, they can affect the microbiota composition and their metabolic
activity. Increased levels of oxidative stress and inflammation are encountered
in the elderly population. Moreover, elderly have a lower antioxidant status
when compared to younger age groups. Oxidative stress and inflammation are
implicated in the pathogenesis of various diseases such as cardiovascular
disease, neurodegenerative disorders and cancer. Administration of citrus
flavonoids to the elderly population might decrease oxidative stress and
inflammation and improve antioxidant status.
Study objective
The aim of this study is to investigate the effect of citrus extract
supplementation on markers of oxidative stress in elderly.
Study design
This is a randomized, double-blind, placebo-controlled, cross-over trial in
elderly subjects.
Intervention
Each subject will undergo two different intervention periods, during which
daily citrus extract or placebo will be supplemented for four weeks. The order
of intervention will be decided by a randomization procedure. Two capsules have
to be ingested every day before the first meal with a glass of water.
Study burden and risks
There are different burdens volunteers can experience during the study. Burdens
that volunteers can experience are: the time spent on the study (subjects will
have to invest approximately 8 hours in the study), subjects will have to take
daily citrus extract or placebo supplements for a total period of 8 weeks (two
periods of 4 weeks) and they have to follow a dietary and healthy regimen and
cannot use alcohol and must abstain from physical exercise prior to the test
days. Moreover, they will have to discuss their medical history with the
investigator, fill in several questionnaires and a maximum total of 138 mL
blood will be sampled during the four study visits by venipuncture. This may
lead to minor discomfort and can cause small and transitory hematoma/bruises to
appear.
universiteitssingel 40
Maastricht 6229 ER
NL
universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
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)
* 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 medication 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03580447 |
| CCMO | NL65863.068.18 |