Sleep DisorderNCT06378034
Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia
A study testing Lactium in people with Sleep Disorder, run by Ingredia S.A..
Trial summary
The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Lactium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2024to 30 Sep 2026
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 ...)
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- 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
Who cannot join
- Presenting moderate to severe insomnia defined by an ISI score greater than or equal to 15 in the last month prior to selection
- Presenting other sleep disorders already diagnosed or suspected during the screening visit: impatience (restless legs), parasomnias, hypersomnias, sleep apnea, iatrogenic insomnia
- Subject assessed as "definitely" an evening type people by the Horne and Ostberg's circadian typology questionnaire (delayed phase subject)
- Whose sleep disorders are related to external factors (noise pollution, young children, etc ...)
- Workers with atypical schedules (night work, staggered working hours, changes in regular working hours, or shift work)
- Smoker
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- Drug Addict
- Alcohol consumption greater than 2 glasses per day
- 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)
- 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 ...)
- 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
- 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
- Untreated or not controlled hypertension
- Untreated or not controlled thyroid diseases (hypo or hyperthyroidism, Graves' disease...)
- Epileptic subject
- Asthmatic subject
- 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
- Confirmed cow's milk protein allergy
- 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.)
- Likely to sleep outside their home during the study (holidays, regular business trips, etc.)
- Whose spouse or partner is participating in this study
- Pregnant woman (negative urine test at screening and initial/randomization visits) or wishing to be pregnant during the study or breastfeeding
- 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)
- Under legal protection (guardianship, curatorship) or deprived of rights following an administrative or judicial decision
- Psychologically or linguistically incapable of understanding and signing informed consent
- Participating in another clinical trial or in exclusion period of a previous clinical trial
- Having reached the maximum research compensation threshold stipulated by regulations.
About this study
Official title: 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.
- Conditions
- Sleep Disorder
- Being tested
- Lactium, Placebo
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactiumDietary supplement
300 mg per day, taken 30 min to 60 min before bedtime
PlaceboDietary supplement
300 mg per day, taken 30 min to 60 min before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Lactium | Active comparator | Not described Receives: Dietary Supplement: Lactium |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
The primary endpoint will be changes between baseline and final sleep efficiency (SE), measured nightly using actigraphy
Measured: Before treatment (day 0); at the end of the treatment (after 29 days)
Secondary outcomes (4)
Sleep diary
Changes between baseline and final subjective sleep quality parameters, recorded in the sleep diary
Measured: Before treatment (day 0); at the end of the treatment (after 29 days)
Insomnia Severity Index
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.
Measured: Before treatment (day 0); at the end of the treatment (after 29 days)
PSQI
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
Measured: Before treatment (day 0); at the end of the treatment (after 29 days)
Sleep quality by cctigraphy
Changes between baseline and final objective sleep quality by actigraphy
Measured: Before treatment (day 0); at the end of the treatment (after 29 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start10 Jun 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ingredia S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378034
- Sponsor's protocol ID
- 2023-A01926-39
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactium on Sleep Efficiency and Quality in Healthy Volunteers With Persistent Subclinical Insomnia
- ClinicalTrials.gov ID
- NCT06378034
- Acronym / sponsor ID
- 2023-A01926-39
- Conditions
- Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ingredia S.A.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Apr 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.
The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactium | Active comparator | Dietary Supplement: Lactium |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (27 listed)
- Presenting moderate to severe insomnia defined by an ISI score greater than or equal to 15 in the last month prior to selection
- Presenting other sleep disorders already diagnosed or suspected during the screening visit: impatience (restless legs), parasomnias, hypersomnias, sleep apnea, iatrogenic insomnia
- Subject assessed as "definitely" an evening type people by the Horne and Ostberg's circadian typology questionnaire (delayed phase subject)
- Whose sleep disorders are related to external factors (noise pollution, young children, etc ...)
- Workers with atypical schedules (night work, staggered working hours, changes in regular working hours, or shift work)
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 |
|---|---|---|
| Lactium300 mg per day, taken 30 min to 60 min before bedtime | Dietary supplement | Lactium |
| Placebo300 mg per day, taken 30 min to 60 min before bedtime | Dietary supplement | Placebo |
Primary outcome
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
4 secondary outcomes
Sleep diary
Time frame: 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)
PSQI
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Lactium in people with Sleep Disorder, run by Ingredia S.A..
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 10 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Sleep efficiency (time frame: Before treatment (day 0); at the end of the treatment (after 29 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2024.