The effect of citrus extract on sleep and mental wellbeing

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 70

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to assess the effect of 8 weeks of supplementing daily<br /><br>500 mg citrus extract rich in the flavonoids hesperidin and naringin on<br /><br>parameters of sleep quality. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to study the effects on mental wellbeing<br /><br>(depression, anxiety and stress outcomes). Exploratory study objectives are to<br /><br>study the effect on faecal microbiota composition, faecal short-chain fatty<br /><br>acid (SCFA) concentrations, blood biomarkers related to mental wellbeing (BDNF,<br /><br>dopamine, serotonin) and blood biomarkers of metabolic health (total<br /><br>cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, CRP, glucose,<br /><br>insulin and HOMA-IR). </p><br>