Alpha-s1 Casein Hydrolysate on Sleep

December 29, 2023 updated by: Chun-pai Yang, MD, Kuang Tien General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 433
        • Kuang Tien General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACH (Aalpha-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.
Dietary supplement: alpha-s1 casein hydrolysate
150mg of Prelactium per capsule
Other Names:
  • Prelactium
Placebo Comparator: Placebo (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.
Dietary supplement: Maltodextrin
150mg of Maltodextrin per capsule

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuang Tien General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTGH11008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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