Tokyo, Feb. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060571) titled 'A study to evaluate the postprandial increase in blood triglyceride levels after consumption of a single serving of processed food product' on Feb. 3.

Study Type: Interventional

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

Primary Sponsor: Institute - NISSIN FOODS HOLDINGS CO., LTD.

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

Objective: Narrative objectives1 - To confirm the effect of single serving of processed food product on postprandial blood triglyceride levels Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of test food1 (single serving) - washout period - test food2 (single serving) - washout period - test food3 (single serving) Interventions/Control_2 - Intake of test food2 (single serving) - washout period - test food3 (single serving) - washout period - test food1 (single serving)

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - (1) Healthy males from 20 to 59 years of age (2) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study Key exclusion criteria - (1) Subjects who regularly use health foods that may affect the research. (2) Subjects who regularly use pharmaceutical drugs or quasi-drugs and cannot restrict their intake during the research period. (3) Subjects who have shown abnormalities in clinical test values or cardiopulmonary function, or have a medical history or surgical history that may affect the study are deemed unsuitable for participation in the study. (4) Subjects who may be at risk of developing allergies in relation to the research. (5) Subjects who require regular medication (whether topical or oral), those currently undergoing treatment for a disease (excluding dry eye or dental caries treatment), and those with a history of severe diseases that required medication treatment. (6) Subjects who work in shifts, night shifts, or have irregular daily schedules. (7) Heavy drinkers. (8) Smoker. (9) Subjects with lactose intolerance (10) Subjects with BMI less than 18.5 or greater than 30.0 kg / m^2 (11) Subjects with fasting blood triglyceride levels greater than 150 mg/dL. (12) Subjects with fasting low-density lipoprotein cholesterol levels greater than 140 mg/dL. (13) Subjects with fasting blood glucose levels less than 70 or greater than 110 mg/dL. (14) Subjects with fasting HbA1c(NGSP) greater than 5.6%. (15) Subjects who have participated in other clinical studies, clinical trials, or human trials from within one month before the date of consent. (16) Subjects expected to experience significant changes in their living environment during the research period. (17) Subjects whose blood donation volume before the start of the study exceeds the regulations. (18) Subjects who regularly skip meals or have extremely irregular eating habits. (19) Subjects deemed inappropriate as subjects by the responsible investigator due to background information, pre-examination results, or other reasons. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 29 Day Date of IRB - 2026 Year 01 Month 29 Day Anticipated trial start date - 2026 Year 02 Month 04 Day Last follow-up date - 2026 Year 03 Month 12 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069282

Disclaimer: Curated by HT Syndication.