Alpha-s1 Casein Hydrolysate on Sleep

Not Applicable

Completed

• Conditions: Polysomnography; Chronic Insomnia
• Interventions: Dietary Supplement: alpha-s1 casein hydrolysate; Dietary Supplement: Maltodextrin

• Registration Number: NCT06199596
• Lead Sponsor: Kuang Tien General Hospital

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-29
• Last Update Submitted: 2023-12-29
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACH (Aalpha-s1 casein hydrolysate)	alpha-s1 casein hydrolysate	Each participant will take Prelactium capsules (alpha-s2 casein hydrolysate supplement; 150mg per capsule) 30 minutes before bedtime for a duration of 4 weeks: 4 capsules in the first two weeks and 2 capsules in the last two weeks.
Placebo (Maltodextrin)	Maltodextrin	Each participant will take Maltodextrin capsules (150mg per capsule) 30 minutes before bedtime for a duration of 4 weeks: 4 capsules in the first two weeks and 2 capsules in the last two weeks.

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	2nd and 4th week	A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality.
General Sleep Disturbance Scale (GSDS)	2nd and 4th week	A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance).
Insomnia Severity Index (ISI)	2nd and 4th week	A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Hospital Anxiety and Depression Scale (HADS)	2nd and 4th week	A sleep-related questionnaire, ranging from 0 to 21. A total score of \>8 points denotes considerable symptoms of anxiety or depression.
Epworth Sleepiness Scale (ESS)	2nd and 4th week	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.
Sleep quality	baseline and 4th week	Polysomnography (PSG)

Trial Locations

Locations (1)

Kuang Tien General Hospital; 🇨🇳 Taichung, Taiwan