Alpha-s1 Casein Hydrolysate on Sleep

Kuang Tien General Hospital

Status: Completed

Conditions: Chronic Insomnia; Polysomnography

Treatments: Dietary Supplement: alpha-s1 casein hydrolysate; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT06199596

KTGH11008

Details and patient eligibility

About

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.

Full description

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

Enrollment: 38 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

ACH (Aalpha-s1 casein hydrolysate)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: alpha-s1 casein hydrolysate

Placebo (Maltodextrin)

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Maltodextrin