Alpha-s1 Casein Hydrolysate on Sleep

N/ACompletedNCT06199596

Kuang Tien General Hospital38 enrolled

Overview

This study investigates the impact of Aalpha-s1 casein hydrolysate (ACH; Lactium®) on sleep quality in individuals with chronic insomnia, employing both subjective sleep profiles and objective polysomnography (PSG) recordings.

During the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Chronic Insomnia Polysomnography

Interventions

alpha-s1 casein hydrolysateDIETARY_SUPPLEMENT

150mg of Prelactium per capsule

MaltodextrinDIETARY_SUPPLEMENT

150mg of Maltodextrin per capsule

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD) (Third Edition); 2. PSQI score greater than 5; 3. participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form. Exclusion Criteria: 1. currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks); 2. patients with a history of significant head trauma; 3. individuals with alcohol abuse within the past year; 4. those with other severe medical conditions (e.g., hepatic or renal dysfunction); 5. Pregnant women or breastfeeding mothers; 6. participants unable to comply with the trial schedule; 7. individuals on a vegetarian diet; 8. those with allergies to dairy products.

Locations (1)

Kuang Tien General Hospital

Taichung, Taiwan

Outcomes

Primary Outcomes

Insomnia Severity Index (ISI)

A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.

Time frame: 2nd and 4th week

Pittsburgh Sleep Quality Index (PSQI)

A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality.

Time frame: 2nd and 4th week

Epworth Sleepiness Scale (ESS)

A sleep-related questionnaire, ranging from 0 to 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness.

Time frame: 2nd and 4th week

General Sleep Disturbance Scale (GSDS)

A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance).

Time frame: 2nd and 4th week

Hospital Anxiety and Depression Scale (HADS)

A sleep-related questionnaire, ranging from 0 to 21. A total score of \>8 points denotes considerable symptoms of anxiety or depression.

Time frame: 2nd and 4th week

Sleep quality

Polysomnography (PSG)

Time frame: baseline and 4th week

Data from ClinicalTrials.gov

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