Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059724) titled 'The exploratory study on the effect of peptide-containing foods in healthy adults: A randomized, double-blind, parallel-group controlled trial' on Nov. 11.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Faculty of Agriculture,Kyushu University
Condition:
Condition - Healthy person
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effect of eating peptide-containing foods on reducing fatigue in daily life
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of peptide-containing foods daily for 4 weeks
Interventions/Control_2 - Intake of Placebo daily for 4 weeks
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Those who with temporary fatigue symptoms
2.Those who have obtained the prior consent of the individual through electronic consent
Key exclusion criteria - 1.If you have chronic fatigue symptoms
2.If you are undergoing treatment for any disease at a medical institution
3.If you have a serious illness or a history of serious illness
4.If the subject habitually intake medicines, supplements, nutrient-fortified foods, or vitamin pills.
5.Have a current or history of drug allergy or food allergy (those who are at risk of developing allergic symptoms to the Test food)
6.Those who have participated or are currently participating in other clinical trials within 1 month of obtaining consent, or those who are scheduled to participate during the study period
7.Those who drink a lot of alcohol daily (60 g alcohol equivalent per day)
8.Those who smoke
9.Those who work at night
10.Those who are judged to be inappropriate as participants for this study by the research collaborate physician
Target Size - 60
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 10 Month 02 Day
Date of IRB - 2025 Year 10 Month 02 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2026 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068306
Disclaimer: Curated by HT Syndication.