Alpha-s1 Casein Hydrolysate on Sleep

Chronic Insomnia Clinical Trial

Official title:

The Effect of Alpha-s1 Casein Hydrolysate for Patients With Chronic Insomnia: A Randomized Double-Blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06199596
• Other study ID #: KTGH11008
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: Kuang Tien General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Insomnia
• Polysomnography
• Sleep Initiation and Maintenance Disorders

Intervention

Dietary Supplement:
• alpha-s1 casein hydrolysate
150mg of Prelactium per capsule
• Maltodextrin
150mg of Maltodextrin per capsule

Locations

Country	Name	City	State
Taiwan	Kuang Tien General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Kuang Tien General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index (ISI)	A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.	2nd and 4th week
Primary	Pittsburgh Sleep Quality Index (PSQI)	A sleep-related questionnaire, ranging from 0 to 21 with the higher total score indicating worse sleep quality.	2nd and 4th week
Primary	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.	2nd and 4th week
Primary	General Sleep Disturbance Scale (GSDS)	A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance).	2nd and 4th week
Primary	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.	2nd and 4th week
Primary	Sleep quality	Polysomnography (PSG)	baseline and 4th week