Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061472) titled 'Evaluation of the Effect of a Test Food on Body Fat Reduction
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -' on May 11.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the body fat-reducing effects and safety of consuming the test food.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Oral ingestion of a test food (1 packet in a day; 12 weeks).
Interventions/Control_2 - Oral ingestion of a placebo food (1 packet in a day; 12 weeks).
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Healthy men and women aged 20 to 64 at the time of obtaining consent to participate in the study.
2) Individuals with a BMI of 23.0 kg/m2 or higher but less than 30.0 kg/m2.
3) Individuals who have received a thorough explanation of the study's purpose and content, possess the capacity to consent, have voluntarily applied to participate after fully understanding the study, and are able to provide written consent to participate in the study.
4) Individuals who are able to visit the facility on the designated examination date and undergo the examination.
5) Individuals deemed suitable for participation in the study by the principal investigator.
Key exclusion criteria - Individuals
1) currently suffering from any medical condition and undergoing treatment.
2) with a current history of chronic fatigue syndrome, mental disorders, sleep disorders, hypertension, diabetes, or dyslipidemia, or a history of serious medical conditions.
3) with a current or past history of serious conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system.
4) who have taken or applied medication for the treatment of a medical condition within the past month.
5) with non-removable metal implants in their bodies or who use a pacemaker.
6) who have donated blood or similar fluids in amounts exceeding 200 mL within the past month or 400 mL within the past three months.
7) who may experience allergic reactions to the test food, or who may experience allergic reactions to other foods or medications.
8) who have experienced significant weight changes (approximately 5% of body weight as a guideline) within three months prior to the start of this trial.
9) whose average weekly alcohol intake (in terms of pure alcohol) exceeds 40 g/day for men and 20 g/day for women.
10) who currently have, or have had within the past 3 months, a habit of regularly consuming health foods containing functional dietary fibers such as resistant dextrin or inulin, or who plan to consume such products during the study period.
11) who currently have, or have had within the past three months, a habit of regularly consuming foods for specific health uses, foods with functional claims, or health foods that claim to reduce body fat, or who plan to consume such products during the trial period.
12) whose lifestyle may change during the study period.
13) who are pregnant, breastfeeding, or who may become pregnant.
14) currently participating in another clinical trial, or those who have participated in another clinical trial within the past 3 months.
15) Any other individuals deemed unsuitable for this study by the principal investigator.
Target Size - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 31 Day
Date of IRB - 2026 Year 04 Month 01 Day
Anticipated trial start date - 2026 Year 06 Month 20 Day
Last follow-up date - 2026 Year 10 Month 14 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069954
Disclaimer: Curated by HT Syndication.
