Tokyo, May 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061326) titled 'Effects of exercise and tea catechin intake on physical and mental function in middle-aged adults' on May 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Kagoshima University
Condition:
Condition - Middle-aged adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study was to investigate the effects of an intervention involving exercise and tea catechin intake on physical and mental function in healthy middle-aged adults who require lifestyle improvement, such as those without regular exercise habits.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention group:
24-week intervention period
Tea catechin powder intake
Resistance training (recommended: at least twice per week)
Interventions/Control_2 - Control group:
24-week intervention period
Consumption of placebo powder
Resistance training (recommended: at least twice per week)
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - 1) Individuals without regular exercise habits
2) Men and women aged 40 to 64 years
Key exclusion criteria - 1) Those who do not intend to exercise during the period.
2) Those who drink green tea frequently (more than 4 cups per day)
3) Currently taking medication or receiving outpatient treatment for a serious medical condition
4) Those currently under medical supervision for exercise or diet therapy
5) Individuals for whom exercise is contraindicated by a physician's judgment
6) People who have ever felt unwell after the consumption of green tea
7) Individuals with a current or past history of drug or alcohol addiction
8) Individuals who are currently receiving outpatient treatment for mental disorders (e.g. depression) or sleep disorders, or who have a history of mental illness
9) Individuals with extremely irregular lifestyles and rhythms, such as eating and sleeping patterns
10) Pacemaker users
11) Individuals who have participated in other clinical trials (research) within 3 months prior to the date of consent, or who plan to participate in other clinical trials (research) during the study period
12) Persons who are unable to comply with the recording of compliance with the various survey forms
13) People with allergies to green tea, barley grass or starch
14) Individuals who are otherwise deemed ineligible
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 10 Day
Anticipated trial start date - 2026 Year 05 Month 10 Day
Last follow-up date - 2027 Year 05 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069678
Disclaimer: Curated by HT Syndication.