Effects of consumption of the test food on the swelling in healthy Japanese

Effects of consumption of the test food on the swelling in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison trial - Effects of consumption of the test food on the swelling in healthy Japanese

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000057170

Enrollment

Registered

2025-02-28

Start date

2025-02-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese

Interventions

Duration: one week &lt

Test 1&gt

Active food &lt

Test 2&gt

Placebo food *The intervention sequence is Test 1 to Test 2. *The washout period is about two weeks. Duration: one week &lt

Placebo food &lt

Active food *The intervention sequence is Test 1 to Test 2. *The washout period is about two weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who concerns about swollen face in daily 6. Individuals whose VAS of "I feel swelling face" more than 50 mm in the morning at screening

Exclusion criteria

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 medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product, particularly those allergic to eggs 7. Individuals whose BMI is less than 18.5 kg/m2 or 30 kg/m2 or more 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 have a present condition or have a medical history of drug or alcohol dependence 11. Individuals who drink pure alcohol > 60 g/day at least 4 days per week 12. Individuals who take at least 400 mg/day of caffeine (about 3 mugs of coffee) 13. Individuals who are undergoing treatment for psychiatric disorder (including depressive symptoms) or sleep disorder 14. Individuals who may take high sodium 15. Individuals who are pregnant, lactating, or planning to become pregnant during this study 16. 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 17. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. The measured value of "I feel swelling face" at a week after intervention (1w) [Value in the morning]	—

Secondary

Measure	Time frame
1. The amount of change from before intervention of "I feel swelling face" at 1w [Value in the morning] 2. The measured values and the amount of changes from before intervention of "I feel swelling face" at 1w [Value in the evening and the difference between evening and morning values (evening minus morning)] 3. The measured values and the amount of changes from before intervention of Visual Analog Scale (VAS) of "I feel swelling around eyes," "I feel like contour is not sharp," "I feel swelling lower legs," "I feel swelling the ankle (such as my shoes or socks feeling tight)," "my hands and feet are cold," "I feel temporarily down due to severe dark circles under my eyes (Dark circles are a temporary condition caused by poor blood circulation around the eyes)," and "I feel temporarily down due to a tired appearance (A tired appearance refers to looking pale or having a drained complexion)" at 1w [Value in the morning, Value in the evening, and the difference between evening and morning values (evening minus morning)] 4. The measured values and the amount of changes from before intervention of calf circumference and ankle circumference at 1w [Value in the morning, Value in the evening, and the difference between evening and morning values (evening minus morning)] 5. The measured values and the amount of changes from before intervention of body weight and BMI at 1w [Value in the morning, Value in the evening, and the difference between evening and morning values (evening minus morning)]	—

Measure

Time frame

1. The amount of change from before intervention of "I feel swelling face" at 1w [Value in the morning] 2. The measured values and the amount of changes from before intervention of "I feel swelling face" at 1w [Value in the evening and the difference between evening and morning values (evening minus morning)] 3. The measured values and the amount of changes from before intervention of Visual Analog Scale (VAS) of "I feel swelling around eyes," "I feel like contour is not sharp," "I feel swelling lower legs," "I feel swelling the ankle (such as my shoes or socks feeling tight)," "my hands and feet are cold," "I feel temporarily down due to severe dark circles under my eyes (Dark circles are a temporary condition caused by poor blood circulation around the eyes)," and "I feel temporarily down due to a tired appearance (A tired appearance refers to looking pale or having a drained complexion)" at 1w [Value in the morning, Value in the evening, and the difference between evening and morning values (evening minus morning)] 4. The measured values and the amount of changes from before intervention of calf circumference and ankle circumference at 1w [Value in the morning, Value in the evening, and the difference between evening and morning values (evening minus morning)] 5. The measured values and the amount of changes from before intervention of body weight and BMI at 1w [Value in the morning, Value in the evening, and the difference between evening and morning values (evening minus morning)]

—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026