Human study for investigating the safety and effectiveness of lactium on the sleep quality

Human study for investigating the safety and effectiveness of lactium on the sleep quality : a randomized, double-blind, placebo-controlled, cross-over study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001867

Enrollment

Registered

2016-04-04

Start date

2016-04-14

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : On the screening visit, subject who voluntarily signs on the written informed consent is reviewed according to inclusion-exclusion criteria. After two-week run-in period, selected

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Participants who give informed consent before the start 2) 20~65 years, healthy men and women (men : women = 1 : 1) 3) Subject with poor sleep quality (Pittsburgh Sleep Quality Index > 5)

Exclusion criteria

Exclusion criteria: 1) Subject with severe sleep disorder (Insomnia severity index = 22) 2) Subject with snoring, sleep apnea, restless legs syndrome, periodic limb movement during sleep and narcolepsy 3) Subject who has experienced excessive stress within 2 weeks prior to the first visit (death of spouse, family discord, immigration, etc.) 4) Subject who took drugs that could have effect on sleeping within one month prior to the first visit 5) Subject receiving hormone therapy 6) Subject who consumes alcohol more than 140g per week (soju about 2.5 bottles/week, about 2.5 glasses/day) 7) Excessive smoking (> 20 cigarettes/day) 8) Subject who consumes excessive caffeine (> 10 cup of coffee/day) 9) Night-shift workers or subject who has irregular bedtime 10) Subject who took extended trip to foreign country within 4 weeks prior to the first visit 11) Body mass index(BMI) = 18 kg/m2 or = 35 kg/m2 12) Subjects who consumed functional foods or oriental medicine within one month prior to first visit 13) Subject sensitive to experimental materials or dairy products 14) Subject who participated in other human studies within one month prior to first visit 15) Pregnant or lactating women 16) Subject unable to use smartphone 17) Any condition that the principal investigator believes may put the subject at undue risk

Design outcomes

Primary

Measure	Time frame
Sleep health questionnaire;Polysomnography	—

Secondary

Measure	Time frame
Actigraph;Salivary cortisol, sIgA ,melatonin	—

Countries

Korea, Republic of

Contacts

Public ContactSoo-Mi Jung

Ewha Womans University Medical Center

hihello2222@naver.com+82-2-2650-5874

Outcome results