Citrus Extract, Sleep and Mental Wellbeing

NCT06239168 | Unknown

• 1 other identifier: 23-012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• Changes in sleep quality scores between the intervention and placebo group

  Measured by a sleep quality questionnaire (PSQI)

  8 weeks of intervention

• Changes in sleep quality between the intervention and placebo group

  Measured using actigraphy

  8 weeks of intervention

Secondary Outcomes (1)

• Changes in mental wellbeing between the intervention and placebo group

  8 weeks of intervention

Study Arms (2)

Citrus extract

EXPERIMENTAL

Daily Citrus extract supplementation for 8 weeks.

Dietary Supplement: Citrus extract

Control

PLACEBO COMPARATOR

Daily Maltodextrin supplementation for 8 weeks.

Dietary Supplement: Maltodextrin

Interventions

Citrus extract DIETARY_SUPPLEMENT

As described in experimental arm

Citrus extract

Maltodextrin DIETARY_SUPPLEMENT

As described in comparator arm

Control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• BioActor: collaborator

Study Sites (1)

Maastricht University

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

Parasomnias

Interventions

grapefruit seed extract; maltodextrin

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jogchum Plat

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Tanja Adam

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yala Stevens, PhD

CONTACT

+31437114555; yala.stevens@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: February 2, 2024
• Study Start: November 8, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

NL (1)