The Sleep Improving Effects of Orange Phenolics

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Fatigue; Sleep; Polyphenols

Treatments: Dietary Supplement: Lozenge containing citrus flavonoid formulation; Dietary Supplement: Identical looking placebo; Dietary Supplement: Lozenge containing citrus flavonoid

Study type: Interventional

Funder types: Other

Identifiers

NCT02209103

NL43845.068.13

Details and patient eligibility

About

This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can improve objective sleep duration and/or quality, and/or improve perceived sleep quality and feelings of rest.

Participants will complete a total of 9 test nights, which consist of sleeping with the sleep monitoring system after ingestion of the test product or a placebo, and filling out sleep-related questionnaires.

The study has a crossover design, meaning that all participants receive all three interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a randomized order.

Enrollment: 77 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75
• Non-smoking
• Healthy
• Lightly disturbed sleep for at least six months, on a regular basis

Exclusion criteria

• Severe sleep disorders (sleep apnea, restless legs syndrome)
• An apparent cause for the sleep disorders (pain, etc.)
• Clinically significant abnormal liver functioning
• Clinically significant abnormal serum creatinine
• BMI lower than 18 or higher than 30 kg/m2
• Use of concomitant medications or supplements

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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77 participants in 3 patient groups, including a placebo group

Citrus flavonoid

Experimental group

Description:

Citrus flavonoid

Treatment:

Dietary Supplement: Lozenge containing citrus flavonoid

Citrus flavonoid formulation

Experimental group

Description:

Citrus flavonoid formulation

Treatment:

Dietary Supplement: Lozenge containing citrus flavonoid formulation

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Identical looking placebo