Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia

April 17, 2024 updated by: Ingredia S.A.

Effect of Lactium on Sleep Efficiency and Quality in Healthy Volunteers With Persistent Subclinical Insomnia

The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • In good general and mental health according to the investigator judgement: no clinically significant and abnormalities relevant to medical history or clinical examination
  • Having a Body Mass Index (BMI) of 18.5 < BMI < 30 kg/m2
  • Present subclinical insomnia characterized by an Insomnia Severity Index (ISI) score between 8 and 14 during the last month preceding the screening visit
  • Whose insomnia symptoms started at least 3 months before the screening visit
  • Present a medium level of phycological stress characterized by a Perceived Stress Scale (PSS-10) score between 14 and 26
  • Willing / able to maintain their eating habits and physical activity during the study (no planned diet, no change in physical activity ...)
  • Willing / able to participate in the study in accordance with protocol procedures (dated and signed informed consent form)
  • Affiliated to a Health insurance scheme
  • Agree to be registered in the national database of subjects participating in clinical research
  • Have a smartphone compatible with the NursTrial® e-PRO application

Exclusion Criteria:

  1. Presenting moderate to severe insomnia defined by an ISI score greater than or equal to 15 in the last month prior to selection
  2. Presenting other sleep disorders already diagnosed or suspected during the screening visit: impatience (restless legs), parasomnias, hypersomnias, sleep apnea, iatrogenic insomnia
  3. Subject assessed as "definitely" an evening type people by the Horne and Ostberg's circadian typology questionnaire (delayed phase subject)
  4. Whose sleep disorders are related to external factors (noise pollution, young children, etc ...)
  5. Workers with atypical schedules (night work, staggered working hours, changes in regular working hours, or shift work)
  6. Smoker
  7. Drug Addict
  8. Alcohol consumption greater than 2 glasses per day
  9. Subject with excessive caffeine consumption exceeding 400 mg per day (coffee ≈ 80 mg per cup; cola soda≈ 25 mg per glass; tea ≈40 mg per cup; energy drinks ≈70 mg per glass)
  10. Subject consuming or having consumed any dietary supplement with an effect or a possible effect on sleep, stress, anxiety, or fatigue during the last 3 months prior to screening visit (melatonin, lactium, ginseng, caffeine ...)
  11. Subject who has been treated during the 6 months preceding the screening visit or are currently being treated with non-medication therapies (such as psychotherapy, Cognitive Behavioral Therapy [CBT], Eye Movement Desensitization and Reprocessing [EMDR], etc. or repetitive Transcranial Magnetic Stimulation [TMS]) or psychotropic medication prescribed and / or recommended for anxious manifestations, depression, sleep disorders and generally for any neurological or psychological manifestation
  12. Subject with psychiatric comorbidity as described in the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) (depression, post traumatic stress disorder, etc.) or history of psychiatric illness
  13. Untreated or not controlled hypertension
  14. Untreated or not controlled thyroid diseases (hypo or hyperthyroidism, Graves' disease...)
  15. Epileptic subject
  16. Asthmatic subject
  17. Any other pathology or medical history or symptomatology likely to significantly influence the study criteria (nocturnal pain, nasal congestion, cough at bedtime or nocturnal cough, nocturnal pollakiuria, tinnitus, etc.) according to the investigator
  18. Confirmed cow's milk protein allergy
  19. Sleeping on a mattress that is not compatible with the sleep quality recording (water and air mattresses) or does not have adequate or necessary domestic equipment for its operation (power socket near the bed, etc.)
  20. Likely to sleep outside their home during the study (holidays, regular business trips, etc.)
  21. Whose spouse or partner is participating in this study
  22. Pregnant woman (negative urine test at screening and initial/randomization visits) or wishing to be pregnant during the study or breastfeeding
  23. Hormonal state that may induce fluctuation in emotional state and sleep during the study, such as, the postpartum period (< 6 months after delivery) and perimenopause (irregular menstrual cycle, hot flashes)
  24. Under legal protection (guardianship, curatorship) or deprived of rights following an administrative or judicial decision
  25. Psychologically or linguistically incapable of understanding and signing informed consent
  26. Participating in another clinical trial or in exclusion period of a previous clinical trial
  27. Having reached the maximum research compensation threshold stipulated by regulations.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Dietary supplement: Placebo
300 mg per day, taken 30 min to 60 min before bedtime
Active Comparator: Lactium
Dietary supplement: Lactium
300 mg per day, taken 30 min to 60 min before bedtime

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep efficiency
Time Frame: Before treatment (day 0); at the end of the treatment (after 29 days)
The primary endpoint will be changes between baseline and final sleep efficiency (SE), measured nightly using actigraphy
Before treatment (day 0); at the end of the treatment (after 29 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep diary
Time Frame: Before treatment (day 0); at the end of the treatment (after 29 days)
Changes between baseline and final subjective sleep quality parameters, recorded in the sleep diary
Before treatment (day 0); at the end of the treatment (after 29 days)
Insomnia Severity Index
Time Frame: Before treatment (day 0); at the end of the treatment (after 29 days)
Changes between the baseline and intermediate and final values of the Insomnia Severity Index (ISI) total score Present subclinical insomnia characterized by an Insomnia Severity Index (ISI) score between 8 and 14 e. The sub-scores of the ISI correspond to 0-7: Lack of insomnia, 8-14: Subthreshold (=subclinical) insomnia, 15- 21: Moderate insomnia, 22-28: Severe insomnia.
Before treatment (day 0); at the end of the treatment (after 29 days)
PSQI
Time Frame: Before treatment (day 0); at the end of the treatment (after 29 days)
Changes between the baseline and final values of Pittsburgh Sleep Quality Index (PSQI) total score Score 0: no sleep diroders, >5 moderate sleep disorders; 21: severe sleep disorders
Before treatment (day 0); at the end of the treatment (after 29 days)
Sleep quality by cctigraphy
Time Frame: Before treatment (day 0); at the end of the treatment (after 29 days)
Changes between baseline and final objective sleep quality by actigraphy
Before treatment (day 0); at the end of the treatment (after 29 days)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ingredia S.A.

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-A01926-39

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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