Tokyo, April 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059140) titled 'Effects of consumption of the test food on swelling in healthy Japanese' on April 30.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Fujicco 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 swelling in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single administration (two periods)

Test 1: Active food Test 2: Placebo food Lunch on each test day: Prescribed food

*Test 1 followed by Test 2. *The washout period will be two weeks.

*Consume one capsule of the active food or placebo food with water after completing the morning measurements in each test of this study. *The prescribed meal will be consumed 2 hours after the start of the loading phase in each test. *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. Interventions/Control_2 - Single administration (two periods)

Test 1: Placebo food Test 2: Active food Lunch on each test day: Prescribed food

*Test 1 followed by Test 2. *The washout period will be two weeks.

*Consume one capsule of the active food or placebo food with water after completing the morning measurements in each test of this study. *The prescribed meal will be consumed 2 hours after the start of the loading phase in each test. *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 - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged between 20 and 64

4. Healthy individuals

5. Individuals who are concerned about lower leg swelling

6. Individuals whose BMI is >= 18.5 kg/m2 and < 30.0 kg/m2 at screening

7. Individuals with a large diurnal variation in lower leg volume (swelling) at screening

8. Individuals whose systolic blood pressure is < 130 mmHg and diastolic blood pressure is < 90 mmHg at screening

9. Individuals with no abnormalities in kidney function as determined by urinalysis at screening Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who 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. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medicines (including herbal medicines) or supplements

6. Individuals who are allergic to medicines or foods related to the test product

7. Individuals with drinking habits exceeding moderate consumption

8. Individuals whose lifestyles are irregular due to working a late-night shift or others

9. Individuals who are undergoing exercise or alimentary therapy under medical supervision

10. Individuals who are pregnant, lactating, or planning to become pregnant during this study

11. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

12. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 40

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 09 Month 10 Day Date of IRB - 2025 Year 09 Month 10 Day Anticipated trial start date - 2025 Year 09 Month 19 Day Last follow-up date - 2025 Year 12 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067652

Disclaimer: Curated by HT Syndication.