Tokyo, March 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057951) titled 'A verification study of blood amino acid levels at intake of protein material' on March 31.

Study Type: Interventional

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

Primary Sponsor: Institute - Mitsubishi Corporation Life Sciences Limited

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify blood amino acid levels at intake of protein material and the absorption of protein material. To characterize protein derived from test material A by verifying protein utilization and absorption rate compared to existing milk protein (animal) and soy protein (plant). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Single ingestion (three times) Test product: Protein derived from test material A Soy protein Milk protein (whey protein)

Intake method: Add 200 mL of water and the test product to a shaker container, intake after thoroughly stirring. Immediately afterward, add 100 mL of water again to the empty shaker container and intake after thoroughly stirring for total consumption. Then intake 50 mL of water for oral refreshment. (The entire process described above should be conducted over a period of five minutes so that all individuals are at the same pace.)

*The washout period is at least one week. *The intervention sequence is Test 1 to Test 3. Interventions/Control_2 - Duration: Single ingestion (three times) Test product: Soy protein Milk protein (whey protein) Protein derived from test material A

Intake method: Add 200 mL of water and the test product to a shaker container, intake after thoroughly stirring. Immediately afterward, add 100 mL of water again to the empty shaker container and intake after thoroughly stirring for total consumption. Then intake 50 mL of water for oral refreshment. (The entire process described above should be conducted over a period of five minutes so that all individuals are at the same pace.)

*The washout period is at least one week. *The intervention sequence is Test 1 to Test 3.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Japanese 2. Men or women 3. Individuals aged >= 20 and = 18.5 kg/m2 and = 60 g/day a week 8. Individuals who are smokers or have quit smoking within the last year 9. Individuals whose lifestyles or dietary habits are irregular due to working a late-night shift or others 10. Individuals who have food allergies or food intolerances including the test foods and the prescribed food 11. Individuals who have a history of serious diseases of digestive organs, or surgical history of digestive organs 12. Individuals who have developed abdominal pain or gastrointestinal symptoms due to consuming high-protein foods 13. Individuals who have or have a history of a diseases which influence digestion and absorption of nutrients 14. Individuals who are taking steroids, protease inhibitors, or antipsychotics 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 Target Size - 15

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 05 Month 12 Day Date of IRB - 2025 Year 05 Month 12 Day Anticipated trial start date - 2025 Year 05 Month 23 Day Last follow-up date - 2025 Year 08 Month 04 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066251

Disclaimer: Curated by HT Syndication.