Citrus Extract, Sleep and Mental Wellbeing

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Sleep Disturbance

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Citrus extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06239168

23-012

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing.

Full description

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 promising results, but evidence from human studies is still limited. Therefore, the aim of the present study is to investigate the effect of a citrus extract on sleep and mental wellbeing in healthy subjects with (minor) sleep disturbance.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals with (minor) sleep disturbance
• Age 40-70 years
• BMI 18.5 - 30 kg/m2
• Willingness to give up being a blood donor from 4 weeks before the start of the study, during the study and for 4 weeks after completion of the study

Exclusion criteria

• Excessive caffeine use
• Major psychiatric/mental health disorders .
• Chronic sleep disorders
• Severe sleep disturbance for more than 1 year
• Other clear causes for poor sleep quality or mental wellbeing
• Use of medication or supplements that can affect outcomes
• Nonpharmacological treatment for sleep disorders
• 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
• 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
• Smoking
• Abuse of products
• Known allergy to citruses
• Known pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Citrus extract

Experimental group

Description:

Daily Citrus extract supplementation for 8 weeks.

Treatment:

Dietary Supplement: Citrus extract

Control

Placebo Comparator group

Description:

Daily Maltodextrin supplementation for 8 weeks.

Treatment:

Dietary Supplement: Maltodextrin