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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378034
• Other study ID #: 2023-A01926-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: April 2024
• Source: Ingredia S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2026
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Dietary Supplement:
• Lactium
300 mg per day, taken 30 min to 60 min before bedtime
• Placebo
300 mg per day, taken 30 min to 60 min before bedtime

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ingredia S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)