A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000026673
• Date of registration: 24/03/2017
• Prospective Registration: Yes
• Primary sponsor: TTC Co.,Ltd.
• Public title: A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females
• Scientific title: A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females - A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females
• Date of first enrolment: 2017/03/25
• Target sample size: 32
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030558
• Study type: Interventional
• Study design: Cross-over Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Hiroyasu Shimada
• Affiliation: TTC Co., Ltd. Clinical Research Planning Department

• Name: Hideki Hokazono
• Affiliation: Sanwa Shurui Co., Ltd. Research Laboratory

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) Subjects who routinely use food or medicine containing of GABA 2) Subjects who perform an act for the improvement of the fatigue, the quality of the sleep, and stress 3) Subjects who routinely intake foods that possibly affect sleep, stress, and fatigue 4) Subjects who wake after sleep onset for nocturia twice and more than twice a week 5) Subjects who have a possibility of feeling stress and affecting sleep due to abstinence 6) Subjects who have a history of hay fever 7) Night and day shift worker or manual laborer 8) Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor 9) Subjects who have under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome 10) Subjects who have had a diagnosis of chronic fatigue syndrome 11) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion 12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires 13) Subjects having possibilities for emerging allergy related to the study 14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 16) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 17) Subjects who are judged as unsuitable for the study by the investigator for other reasons

Age minimum: 30years-old
Age maximum: 59years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Healthy adult

Intervention(s)

Intake of a GABA - containing food for 2 consecutive weeks - washout period of 2 weeks - intake of placebo for 2 consecutive weeks
Intake of placebo for 2 consecutive weeks - washout period of 2 weeks - intake of a GABA-containing food for 2 consecutive weeks

Primary Outcome(s)

Stress: POMS 2-A Short Sleep: electroencephalography

Secondary Outcome(s)

Fatigue: Fatigue VAS Sleep: OSA Sleep Inventory for Middle-Aged and Aged

Source(s) of Monetary Support

Sanwa Shurui Co., Ltd.

Ethics review

Status: YES
Approval date:
Contact: