Tokyo, April 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057744) titled 'Effects of consumption of the test food on blood amino acid levels: a randomized, open-label, single-ingestion, crossover comparison study' on April 30.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - PlasMEDi Inc.

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 blood amino acid levels Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single ingestion

Test 1: High protein powder Test 2: Commercially available milk (Meiji Oishii Gyunyu)

Test 1: Dissolve 20 g of high protein powder in 442 mL of water and consume it within 15 minutes after completing the pre-consumption measurement. Test 2: Consume 442 mL within 15 minutes after completing the pre-consumption measurement.

*The intervention sequence is Test 1 to Test 2. *The washout period is one week or more. Interventions/Control_2 - Single ingestion

Test 1: Commercially available milk (Meiji Oishii Gyunyu) Test 2: High protein powder

Test 1: Consume 442 mL within 15 minutes after completing the pre-consumption measurement. Test 2: Dissolve 20 g of high protein powder in 442 mL of water and consume it within 15 minutes after completing the pre-consumption measurement.

*The intervention sequence is Test 1 to Test 2. *The washout period is one week or more.

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 60

4. Healthy individuals

5. Individuals whose body mass index (BMI) is less than 30 kg/m2 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 medications (including herbal medicines) or supplements

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

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

8. Individuals who have food allergies or food intolerances, particularly lactose intolerance

9. Individuals who have developed abdominal pain or gastrointestinal symptoms due to consuming high-protein foods

10. Individuals who have or are undergoing medical treatment for diseases that influence digestion and absorption of nutrients

11. Individuals who are taking steroids, protease inhibitors, or antipsychotics

12. Individuals who are smokers

13. Individuals who have difficulty consuming the food in the prescribed administration

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

15. 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

16. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 14

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 04 Month 09 Day Date of IRB - 2025 Year 04 Month 09 Day Anticipated trial start date - 2025 Year 04 Month 30 Day Last follow-up date - 2025 Year 06 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065983

Disclaimer: Curated by HT Syndication.