Chronic InsomniaNCT06199596
Alpha-s1 Casein Hydrolysate on Sleep
A study testing alpha-s1 casein hydrolysate and Maltodextrin in people with Chronic Insomnia and Polysomnography, run by Kuang Tien General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Insomnia, Polysomnography
- What is being tested?
- alpha-s1 casein hydrolysate and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2019to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD) (Third Edition);
- PSQI score greater than 5;
- participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form.
Who cannot join
- currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks);
- patients with a history of significant head trauma;
- individuals with alcohol abuse within the past year;
- those with other severe medical conditions (e.g., hepatic or renal dysfunction);
- Pregnant women or breastfeeding mothers;
- participants unable to comply with the trial schedule;
- individuals on a vegetarian diet;
- those with allergies to dairy products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
During the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.
- Conditions
- Chronic Insomnia, Polysomnography
- Being tested
- alpha-s1 casein hydrolysate, Maltodextrin
- Keywords
- Alpha-s1 casein hydrolysate, Randomized controlled trial, insomnia, Polysomnography
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha-s1 casein hydrolysateDietary supplement
Also called Prelactium
150mg of Prelactium per capsule
MaltodextrinDietary supplement
150mg of Maltodextrin per capsule
| Study group | Role | What they receive |
|---|---|---|
| ACH (Aalpha-s1 casein hydrolysate) | Experimental | 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. Receives: Dietary Supplement: alpha-s1 casein hydrolysate |
| Placebo (Maltodextrin) | Placebo comparator | 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. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
A sleep-related questionnaire, ranging from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
Measured: 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.
Measured: 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.
Measured: 2nd and 4th week
General Sleep Disturbance Scale (GSDS)
A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance).
Measured: 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.
Measured: 2nd and 4th week
Sleep quality
Polysomnography (PSG)
Measured: baseline and 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 May 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuang Tien General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-pai Yang, MD, Kuang Tien General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199596
- Sponsor's protocol ID
- KTGH11008
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang CM, Tsai IJ, Yang CC, Liu WC, Yang CP. The impact of Alpha-s1 Casein hydrolysate on chronic insomnia: A randomized, double-blind controlled trial. Clin Nutr. 2024 Dec;43(12):275-284. doi: 10.1016/j.clnu.2024.10.039. Epub 2024 Nov 6.
PubMed 39541860
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alpha-s1 Casein Hydrolysate for Patients With Chronic Insomnia: A Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06199596
- Acronym / sponsor ID
- KTGH11008
- Conditions
- Chronic Insomnia, Polysomnography
- Keywords
- Alpha-s1 casein hydrolysate, Randomized controlled trial, insomnia, Polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Kuang Tien General HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACH (Aalpha-s1 casein hydrolysate) | Experimental | Dietary Supplement: alpha-s1 casein hydrolysateEach 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) | Placebo comparator | Dietary Supplement: MaltodextrinEach 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD) (Third Edition);
- PSQI score greater than 5;
- participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form.
Key exclusion criteria (8 listed)
- currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks);
- patients with a history of significant head trauma;
- individuals with alcohol abuse within the past year;
- those with other severe medical conditions (e.g., hepatic or renal dysfunction);
- Pregnant women or breastfeeding mothers;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alpha-s1 casein hydrolysateAlso: Prelactium150mg of Prelactium per capsule | Dietary supplement | ACH (Aalpha-s1 casein hydrolysate) |
| Maltodextrin150mg of Maltodextrin per capsule | Dietary supplement | Placebo (Maltodextrin) |
Primary outcome
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.
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.
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.
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).
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.
Sleep quality
Time frame: baseline and 4th week
Polysomnography (PSG)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 39541860Chang CM, Tsai IJ, Yang CC, Liu WC, Yang CP. The impact of Alpha-s1 Casein hydrolysate on chronic insomnia: A randomized, double-blind controlled trial. Clin Nutr. 2024 Dec;43(12):275-284. doi: 10.1016/j.clnu.2024.10.039. Epub 2024 Nov 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alpha-s1 casein hydrolysate and Maltodextrin in people with Chronic Insomnia and Polysomnography, run by Kuang Tien General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: 2nd and 4th week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.