Citrus Extract, Sleep and Mental Wellbeing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Citrus extract

Daily Citrus extract supplementation for 8 weeks.

Group Type EXPERIMENTAL

Citrus extract

Intervention Type DIETARY_SUPPLEMENT

As described in experimental arm

Control

Daily Maltodextrin supplementation for 8 weeks.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

As described in comparator arm

Interventions

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Citrus extract

As described in experimental arm

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

As described in comparator arm

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes