NCT06199596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

4.6 years

First QC Date

December 15, 2023

Last Update Submit

December 29, 2023

Conditions

Chronic InsomniaPolysomnography

Keywords

Alpha-s1 casein hydrolysateRandomized controlled trialinsomniaPolysomnography

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • General Sleep Disturbance Scale (GSDS)

    A sleep-related questionnaire, ranging from 0 (no disturbance) to 147 (extreme sleep disturbance).

    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.

    2nd and 4th week

  • Sleep quality

    Polysomnography (PSG)

    baseline and 4th week

Study Arms (2)

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.

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.

Dietary Supplement: Maltodextrin

Interventions

alpha-s1 casein hydrolysateDIETARY_SUPPLEMENT

150mg of Prelactium per capsule

Also known as: Prelactium
ACH (Aalpha-s1 casein hydrolysate)
MaltodextrinDIETARY_SUPPLEMENT

150mg of Maltodextrin per capsule

Placebo (Maltodextrin)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuang Tien General Hospital

Taichung, 433, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Neurology Affiliation: Kuang Tien General Hospital

Study Record Dates

First Submitted

December 15, 2023

First Posted

January 10, 2024

Study Start

May 1, 2019

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

January 10, 2024

Record last verified: 2023-12

Locations

TW(1)