Tokyo, Sept. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059205) titled 'Study on the Effect of Consumption of Test Foods on the Sensation of Fatigue' on Sept. 26.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to examine the effect of four consecutive weeks of consumption of the test food on the feeling of fatigue.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral intake of the test food (1 bottle in a day; 4 weeks)
Interventions/Control_2 - Oral intake of the placebo food (1 bottle in a day; 4 weeks)
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Men and women between 20 and 65 years of age at the time of obtaining consent to participate in the study.
2) Standard Japanese who are healthy and free from chronic physical diseases.
3) Individuals with physical or mental fatigue on a daily basis.
4) Individuals whose written informed consent has been obtained.
5) Individuals who can come to the designated venue for this study and be inspected.
6) Individuals judged appropriate for the study by the principal.
Key exclusion criteria - 1) Individuals with chronic fatigue.
2) Individuals using medical products.
3) Individuals with a current history of mental illness, sleep disorders, hypertension, diabetes, or dyslipidemia, or individuals with a history of serious illness.
4) Individuals with a history of serious illness involving the liver, kidneys, heart, lungs, blood, digestive organs, etc.
5) Individuals who used a drug to treat a disease in the past 1 month.
6) Individuals whose BMI is over 30 kg/m2.
7) Individuals who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug.
8) Individuals with alcohol dependence or whose daily alcohol consumption exceeds an average of 40 g/day for men and 20 g/day for women per week.
9) Individuals with possible changes of life style during the test period.
10) Individuals who currently have a habit of regularly consuming health foods, health supplements, or other supplements, or who plan to consume such products during the trial period, as well as individuals who have done so within the past three months.
11) Individuals who are pregnant, breastfeeding, or may become pregnant, or who intend to become pregnant during the trial period.
12) Individuals who participated in other clinical studies in the past 3 months.
13) Individuals who are or whose family is engaged in healthy or functional foods.
14) Individuals judged inappropriate for the study by the principal.
Target Size - 66
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 18 Day
Date of IRB - 2025 Year 08 Month 20 Day
Anticipated trial start date - 2025 Year 10 Month 15 Day
Last follow-up date - 2025 Year 11 Month 16 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067310
Disclaimer: Curated by HT Syndication.
