Human studies on the effects of BHB on Sleep. -A randomized, placebo-controlled, double-blind, parallel-group comparison study

Recruitment & Eligibility

Status: Complete: follow-up continuing

Sex: All

Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects who 1)are suffering from or have a history of serious liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, or other metabolic disease 2)at high risk of suffering from idiopathic chronic fatigue or chronic fatigue syndrome based on self-report 3)are presumed to be at high risk of suffering from depression based on CES-D scores or other questionnaires 4)with a history of treatment for sleep disorders or current medical history 5)have been diagnosed with sleep apnea syndrome, or suspected of having it 6)are taking medication or consuming supplements (including functional food products) related to sleep and fatigue recovery 7)have digestive disease or a history of digestive surgery 8)have allergy to the research food 9)are pregnant, lactating, or planning to get pregnant 10)with an infant under one year old in a household 11)sleeps with multiple individuals on a single bedding 12)living with someone requiring long-term care 13)have excessive alcohol intake more than approximately 20g/day of pure alcohol equivalent or habit of drinking more than 4 days a week 14)cannot stop drinking from 2 days before each measurement 15)have an experience of drug dependence or alcohol dependence or current illness 16)smokes more than 20 cigarettes a day or cannot to stop smoking from the time they wake up on the measurement day until the end of the measurement 17)are Shift workers, late-night workers, or with irregular working days and holidays 18)regularly engage in strenuous exercise or work 19)have donated blood or blood components exceeding 200 mL within one month prior to the consent date or 400 mL within three months prior to the consent date 20)plan to participate in other clinical study during study periods or had participated in other clinical study within the last 1 month 21)are judged by the principal investigator to be inappropriate as study subjects for other reasons