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

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: Not yet recruiting
• Conditions: Sleep Disorder
• Intervention / Treatment: Dietary supplement: Lactium; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Sleep efficiency	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

Outcome Measure	Measure Description	Time Frame
Sleep diary	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	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	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	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

• Sponsor: Ingredia S.A.

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Parasomnias
• Other Study ID 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