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

NCT06378034 | Not Yet Recruiting

• 1 other identifier: 2023-A01926-39
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sleep diary

  Before treatment (day 0); at the end of the treatment (after 29 days)

• Insomnia Severity Index

  Before treatment (day 0); at the end of the treatment (after 29 days)

• PSQI

  Before treatment (day 0); at the end of the treatment (after 29 days)

• Sleep quality by cctigraphy

  Before treatment (day 0); at the end of the treatment (after 29 days)

Study Arms (2)

Lactium

ACTIVE COMPARATOR

Dietary Supplement: Lactium

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Lactium DIETARY_SUPPLEMENT

300 mg per day, taken 30 min to 60 min before bedtime

Lactium

Placebo DIETARY_SUPPLEMENT

300 mg per day, taken 30 min to 60 min before bedtime

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ingredia S.A.: lead

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 22, 2024
• Study Start: June 10, 2024
• Primary Completion: July 15, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04