Tokyo, March 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060855) titled 'Effects of test food consumption and Exercise load on muscle.
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-' on March 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - KSO Corporation
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effects of test food consumption and exercise load on muscle.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 12-week consumption of the test food
Exercise at the gym and home
Interventions/Control_2 - 12-week consumption of the placebo food
Exercise at the gym and home
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1) Healthy Japanese males and females aged 40 to 74 years-old.
2) Subjects who do not exercise regularly and are aware of declines in muscle strength than before.
3) Subjects whose BMI are under 30.
4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria - Subjects(who)
1) regularly use drugs associated with muscle, lipid metabolism and/or amino acids preparations.
2) contract or have a history of serious diseases (eg, liver, kidney, digestive, heart, respiratory, endocrine, metabolic, skeletal muscle and/or tendon disease)
3) are undergoing or may receive surgical treatment of knee joints.
4) with a cardiac pacemaker or artificial joint, etc.
5) have had severe damage on the locomotive organs such as fracture, tendon rupture, or muscle strain in the past 1 year.
6) with physical disabilities such as severe low back pain and knee pain, which interfere with exercise.
7) are suspected to have sarcopenia as a result of screening.
8) contract or have a surgical history of digestive disease affecting digestion and absorption.
9) can't stop using supplements, and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims or nutritional supplements which contain amino acids and/or proteins).
10) are prohibited from exercising by doctors.
11) declared allergic reactions to foods.
12) can't stop drinking from 2 days before each measurement.
13) have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week.
14)are shift worker and/or midnight-shift worker.
15) are under treatment for or have a history of drug addiction and/or alcoholism.
16) are judged unsuitable as a subject by the investigator based on clinical testing during screening.
17) have donated over 200 mL of blood and/or blood components within the last one month prior to the consent or over 400 mL of blood and/or blood components within the last three months prior to the consent.
18) are pregnant or planning to become pregnant or breastfeed during the study period.
19) are participating in or willing to participate in other clinical studies.
20) are judged unsuitable as a subject by the investigator for other reasons.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 14 Day
Anticipated trial start date - 2026 Year 03 Month 31 Day
Last follow-up date - 2026 Year 08 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069557
Disclaimer: Curated by HT Syndication.
