Tokyo, April 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061140) titled 'A study to verify the effects of consumption of the test food on anti-aging (blood NAD+, skin, sleep) in healthy Japanese: an open-label study' on April 2.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - WELLCREATE Co., Ltd.
Condition:
Condition - Healthy Japanese
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effects of consumption of the test food on anti-aging (blood NAD+, skin, sleep) in healthy Japanese.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Duration: 99 days
Test product: Cell regeneration, Cell repair
Administration: Both Cell regeneration and Cell repair are taken daily. Take four tablets of Cell regeneration 10 minutes before the first meal of the day, and take four tablets of Cell repair 10 minutes before dinner with water per day.
*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Japanese
2. Healthy individuals
3. "Women between 30 and 40 years old whose menstrual cycle has been between 25 and 35 days in the past six months" or "Men between 35 and 55 years old"
Key exclusion criteria - Individuals who
1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2.have a pacemaker or an ICD
3.are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4.are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5.are taking or using medications or supplements
6.usually take food/beverage containing functional ingredients which may influence skin (such as GABA, isoflavones, lactic acid bacteria, bifidobacteria, EPA, DHA, astaxanthin, glucosylceramide, proteoglycans, piceatannol, lycoperosides, collagen peptide)
7.are allergic to medicines or foods related to the test product (particularly, apples)
8.have mental health issues such as depression disorder, ADHD, or other issues
9.have irregular sleeping time or habit due to work such as a late-night shift
10.live with their infants less than one year old
11.sleep with their children (1 to 6 years old)
12.live with requiring long-term care persons
13.sleep with more than one person
14.have irregular lifestyles
15.are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome
16.have been diagnosed with atopic dermatitis
17.habitually receive skincare treatment or use instruments for beauty treatment
18.drink to excess every day
19.have undergone cosmetic surgery
20.are pregnant, lactating, or planning to become pregnant during this study
21.have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study
22.are judged as ineligible to participate in this study by the physician
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 03 Month 11 Day
Date of IRB - 2026 Year 03 Month 11 Day
Anticipated trial start date - 2026 Year 04 Month 02 Day
Last follow-up date - 2026 Year 09 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069957
Disclaimer: Curated by HT Syndication.