Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058476) titled 'The study for exploring functional materials in the frailty.
-A randomized, parallel-group comparison study -' on July 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - KSO Corporation
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effect of Food Material A or Food Material B continuously intake for 12 weeks on the frail status of men between 60 and 80 years old, who have been classified as pre-frail or frail through urinary metabolite analysis, compared to the non-intake group.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of one bottle of study Food A once a day for 12 weeks.
Interventions/Control_2 - Intake of one bottle of study Food B once a day for 12 weeks.
Eligibility:
Age-lower limit - 60
years-old
=
Gender - Male
Key inclusion criteria - 1) Men between 60 and 80 years of age at the time of obtaining consent.
2) Those who are aware that their physical strength has decreased compared to the past.
3) Those who are determined to be in the borderline range in the urinary VOC (frailty index) measurement performed in the screening test.
4) Those who scored 13 points or less on the designated evaluation Measures prior to the screening test.
5) Those who have received a sufficient explanation of the purpose and content of the study, have the ability to consent, voluntarily applied to participate in the study after a good understanding, and have agreed to participate in the study in writing.
Key exclusion criteria - 1) Those with serious illnesses such as cancer, liver damage, kidney damage, heart disease, diabetes, etc.
2) Those who cannot come to the research site by themselves.
3) Those who have difficulty in taking study food.
4) Those who cannot perform the walking test or one leg stand test (those who need a cane, those who have problems in normal walking, etc.).
5) Those who take health foods that may influence the research results.
6) Those who regularly use study food.
7) Those who have a digestive disease or a history of digestive surgery (except appendicitis).
8) Those who have a history or current history of alcohol dependency.
9) Those who have reported food allergies to the study foods.
10) Those who are unable to abstain from alcohol from the day before each test.
11) Those who suffer from mental illness such as depression.
12) Those who have an extremely irregular dietary habit, those who work late-night shifts (including those who work late-night hours), or those who have an irregular rhythm of life.
13) Those who have participated or wish to participate in trials involving the ingestion of other foods or the use of drugs, or the application of cosmetics and drugs, within 3 months before the date of obtaining consent.
14) Those who are judged by the principal investigator to be inappropriate as study subjects for other reasons.
Target Size - 45
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 04 Month 18 Day
Date of IRB - 2025 Year 04 Month 24 Day
Anticipated trial start date - 2025 Year 07 Month 19 Day
Last follow-up date - 2026 Year 01 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066639
Disclaimer: Curated by HT Syndication.