Tokyo, Jan. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056884) titled 'Effects of Test Food Intake on Oxidative Stress and Antioxidant Capacity Study (Subtitles: Effects on Oxidative Stress and Antioxidants Capacity Pre- and Post-Exercise Load)' on Jan. 31.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of continuous intake of the test food for four weeks on oxidative stress and antioxidant capacity pre- and post-exercise load.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will replace one meal per day with the test food at lunch for four weeks.
Interventions/Control_2 - Participants will consume their regular lunch without replacing it with the test food.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Male and female aged 20 to below 65 years at the time of consent acquisition.
2. Individuals who can consume the entire amount of the test food for lunch during the study period without any difficulty.
3. Individuals capable of performing the specified exercise routines implemented during the study.
4. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria - 1. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims of antioxidant or stress-reduction properties, three or more times a week.
2. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims of antioxidant or stress-reduction properties and are unable to discontinue use from the time of consent acquisition.
3. Individuals taking medication that may impact the study (like birth control pills) at least once a week and cannot limit their use during the study period.
4. Individuals with regular exercise habits or who perform physical labor.
5. Individuals planning to engage in activities during the study period that might affect the results, such as exercise, physical labor, outdoor activities, travel, or business trips:
- Intense or long-duration exercises.
- Outdoor activities that involve extensive sun exposure or prolonged outdoor exposure.
6. Individuals who may have difficulty participating in exercise due to surgical conditions or medical disorders
7. Individuals with oral symptoms involving bleeding, such as bleeding from the gums noticeable without brushing or any other stimulation, where the water used for rinsing turns visibly colored.
8. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
9. Individuals with extremely irregular lifestyles, such as those working night shifts.
10. Individuals with highly irregular eating habits.
11. Individuals who are aware of excessive salt intake in their regular diet.
12. Individuals with excessive alcohol intake.
13. Individuals who smoke or have a history of smoking within the last six months from the date of consent meeting.
Target Size - 45
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 01 Month 29 Day
Date of IRB - 2025 Year 01 Month 17 Day
Anticipated trial start date - 2025 Year 02 Month 03 Day
Last follow-up date - 2025 Year 05 Month 04 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064791
Disclaimer: Curated by HT Syndication.
