Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062311) titled 'Effects of intake of the test food on energy intake' on July 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Macromill Carenet, Inc.
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of 12-week continuous intake of the test food on reducing calorie intake in Japanese adults with a BMI from 25 kg/m2 to less than 30 kg/m2.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Continuous intake of the test food (tablet form, 4 tablets per day, 2 tablets in the morning and 2 tablets in the evening) for 12 weeks.
Interventions/Control_2 - Continuous intake of placebo food (tablet form, 4 tablets per day, 2 tablets in the morning and 2 tablets in the evening) for 12 weeks.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Aged 20 to 69 years at the time of informed consent.
(2) Japanese males and females.
(3) Body mass index from 25 to less than 30 kg per square meter.
(4) Individuals who have received a full explanation of the purpose and details of the study, have the capacity to give consent, can fully understand the content, and can provide their own consent via electronic informed consent.
Key exclusion criteria - (1) Individuals receiving or planning to receive medical counseling, treatment, or medication (including private practice prescription) for weight or fat loss.
(2) Individuals with chronic diseases (diabetes, dyslipidemia, hypertension, anemia, perennial allergy, asthma, etc.) receiving treatment/medication.
(3) History of serious cerebrovascular, heart, liver, kidney, blood, or endocrine disease.
(4) History of serious GI surgery (except appendectomy).
(5) Weight fluctuation of 3 kg or more within the past 3 months.
(6) Risk of allergy to test foods (yeast) or load meals.
(7) Significant abnormalities in screening tests.
(8) History of feeling unwell during blood sampling.
(9) Blood donation history (200 mL within 4 weeks, component within 2 weeks for both; 400 mL within 16 weeks for females, 12 weeks for males).
(10) Barium test planned within 2 weeks before or during visits.
(11) Intrabdominal or body metal/medical devices (pacemakers, etc.).
(12) Unable to stop health foods/supplements.
(13) Current smokers.
(14) Heavy alcohol users (around 60 g or more alcohol per day).
(15) Irregular sleep/diet habits (shift/night work).
(16) Expected major changes in lifestyle, diet, or exercise.
(17) Lactating, pregnant, or planning pregnancy.
(18) Current, recent (within 4 weeks), or planned participation in other trials.
(19) Otherwise judged ineligible by the investigator.
Target Size - 48
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 16 Day
Date of IRB - 2026 Year 07 Month 16 Day
Anticipated trial start date - 2026 Year 07 Month 24 Day
Last follow-up date - 2026 Year 12 Month 14 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071300
Disclaimer: Curated by HT Syndication.
