The aim of the present study is to investigate the effect of a citrus extract rich in the flavonoids hesperidin and naringin on sleep quality and mental wellbeing in healthy subjects with sleep (minor) disturbance.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
slaap
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to assess the effect of 8 weeks of supplementing daily
500 mg citrus extract rich in the flavonoids hesperidin and naringin on
parameters of sleep quality.
Secondary outcome
The secondary objectives are to study the effects on mental wellbeing
(depression, anxiety and stress outcomes). Exploratory study objectives are to
study the effect on faecal microbiota composition, faecal short-chain fatty
acid (SCFA) concentrations, blood biomarkers related to mental wellbeing (BDNF,
dopamine, serotonin) and blood biomarkers of metabolic health (total
cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, CRP, glucose,
insulin and HOMA-IR).
Background summary
Based on epidemiological data, a substantial number of people report to have
sleeping problems. This is of major concern, as poor sleep quality has been
associated with impaired mental and physical health. Several pre-clinical
studies have shown that treatment with the citrus flavonoids hesperidin and
naringin may improve sleep and mental wellbeing. However, evidence from human
studies is still limited.
Study objective
The aim of the present study is to investigate the effect of a citrus extract
rich in the flavonoids hesperidin and naringin on sleep quality and mental
wellbeing in healthy subjects with sleep (minor) disturbance.
Study design
A randomized, double-blind, placebo-controlled, cross-over trial
Intervention
Participants will ingest daily before dinner, in random order, 500 mg of citrus
extract or placebo (maltodextrin) capsules for 8 weeks, separated by a 4-week
wash-out.
Study burden and risks
The total study duration will be maximal 21 weeks, including the wash-out
period of 4 weeks. During the study, blood samples will be collected (< 500 mL
in total), which occasionally may cause a hematoma or bruise. Other
measurements are not expected to cause side effects. Subjects will have a time
investment of ± 12,5 hours (screening, six test days).
universiteitssingel 50
Maastricht 6229 ER
NL
universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
men and women, 40-70 years old, BMI 18,5-30 kg/m2, (mild) sleep disturbance
(PSQI score >5), willingness to give up being a blood donor from 4 weeks before
the start of the study until 4 weeks after completion of the study.
Exclusion criteria
• Excessive caffeine use ( >400 mg/day)
• Major psychiatric/mental health disorders (e.g. major depression,
post-traumatic stress disorder, bipolar disorder, schizophrenia).
• Chronic sleep disorders (e.g. sleep apnea, restless leg syndrome, periodic
limb movement disorder)
• Severe sleep disturbance for more than 1 year
• Other clear causes for poor sleep quality, stress, depression or anxiety
(e.g. stressful situation or life event, excessive noise, snoring partner,
infants/children regularly awakening, shift-work, chronic/acute pain)
• Use of medication or supplements that can affect outcomes (e.g.
anti-depression medication, sleeping pills, melatonin)
• Use of medication that can be affected by intake of grapefruit (juice)
• Nonpharmacological treatment for sleep disorders (cognitive behavioural
therapy, relaxation therapy)
• Flight from a time-zone with >3 h difference <=1 week before an intervention
period
• Administration of investigational drugs or participation in any scientific
intervention study which may interfere with this study, to be decided by the
principal investigator, in the 180 days prior to the study
• Use of pre-, pro- or synbiotics within 1 month prior to the start of the study
• Reported weight loss or weight gain of >3 kg in the month prior to pre-study
screening, or intention to lose weight during the study period
• Smoking
• Abuse of products (> 20 alcoholic consumptions per week and drug usage)
• Current use of (antioxidant) dietary supplements and not willing to quit for
the duration of the study duration
• Known allergy to citruses
• Known pregnancy or lactation
Design
Recruitment
Medical products/devices used
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 | NCT06239168 |
| CCMO | NL84076.068.23 |