Tokyo, Sept. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056168) titled 'Evaluation of the effect of food intake on improving sleep' on Sept. 19.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Morinaga & Co., Ltd.
Condition:
Condition - N/A
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects of consuming test foods on sleep and fatigue
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral ingestion of the test food for 4 weeks
Interventions/Control_2 - Oral ingestion of the placebo food for 4 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Males and females aged over 20 to under 60 when informed consent.
2) Suibjects who are dissatisfied with their sleep in daily life
3) Subjects who fully understand the purpose and content of the research and agree to participate in the research of their own free will
Key exclusion criteria - Subjects
1)with an irregular lifestyle.
2) engaged in manual labor such as day/night shifts, late night shifts, or heavy lifting, and those with irregular lifestyles.
3) unsuitable due to their alcohol consumption habits.
4) unsuitable due to their suitability to wear measurement equipment.
5) with an environment that interferes with sleep at bedtime.
6) suspected of, under treatment for, or with a history of sleep apnea syndrome (SAS).
7) who have or are suspected to have nocturia, benign prostatic hyperplasia, or overactive bladder.
8) with or with a history of chronic fatigue syndrome, psychiatric disorders, hypertension, or serious diseases.
9) who have difficulty in carrying out questionnaire, etc., based on pre-test.
10) who may have major depression based on pre-test major depression episode results.
11) who are pregnant, lactating, possibly pregnant during the pre-test, or who wish to become pregnant during the study.
12) taking pharmaceuticals (quasi-drugs) that may affect sleep and fatigue during the pre-test.
13) using health foods that claim effects on sleep and fatigue during the pre-test.
14) in the habit of consuming foods, pharmaceuticals, or quasi-drugs containing ingredients involved in the test food at least once a week.
15) with hay fever requiring medication.
16) with diseases requiring constant medication, under treatment, or with a serious disease or past history requiring medication.
17) who have participated in other clinical trials within the month prior to the pre-test or who wish to participate in other studies during the study period.
18) whose measurements during the pre-test significantly deviate from the reference range.
19) who may develop allergic symptoms to drugs or foods.
20) planning to change their lifestyle during the study period.
21) judged inappropriate based on lifestyle questionnaire results.
22) judged inappropriate based on the responsible physician's judgment.
Target Size - 76
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 11 Month 14 Day
Date of IRB - 2024 Year 11 Month 14 Day
Anticipated trial start date - 2024 Year 12 Month 27 Day
Last follow-up date - 2025 Year 03 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064165
Disclaimer: Curated by HT Syndication.
