Clinical Trial: Effects of Continued Consumption of Commercially Available Emergency Foods on Bowel Habits, Blood Pressure, and Glucose Variability: A Randomized Crossover Trial (Japan)

Tokyo, Aug. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062535) titled 'A study comparing bowel habits, blood pressure,and glucose changes after 5-day consumption of emergency foods and health-conscious foods in healthy adults' on Aug. 11.

Study Type: Interventional

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

Primary Sponsor: Institute - Tokushima University Hospital

Condition: Condition - Changes in bowel habits, blood pressure, body fluid regulation, and glucose variability associated with continued consumption of emergency foods Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to explore the short-term effects of 5-day consumption of commercially available emergency foods, compared with 5-day consumption of health-conscious retort and shelf-stable foods, on bowel movement frequency, stool form, home blood pressure, body fluid composition, blood and urinary markers related to fluid regulation, and interstitial glucose variability measured by continuous glucose monitoring in healthy adult volunteers aged 20 to 60 years. Adherence to the study diets, satisfaction, and safety will also be assessed to identify practical issues in dietary support during disasters. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Participants will consume three meals per day of commercially available emergency foods for 5 days, followed by a 4-week washout period, and then three meals per day of health-conscious foods for 5 days. Interventions/Control_2 - Participants will consume three meals per day of health-conscious foods for 5 days, followed by a 4-week washout period, and then three meals per day of commercially available emergency foods for 5 days.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Participants aged 20 to 60 years at the time of informed consent. No restriction on sex. Healthy adults who, at the time of study participation, have no acute or chronic disease that interferes with activities of daily living. Participants who are able to comply with the 5-day study diet, home blood pressure measurements, recording of bowel movements, food intake, and symptoms in a daily diary, blood and urine tests, body fluid composition measurements, and continuous glucose monitoring using the FreeStyle Libre or an equivalent device. Participants who have received an explanation of the study objectives, procedures, expected benefits, and potential disadvantages, and who voluntarily provide written informed consent. Key exclusion criteria - Participants with: (1) conditions that may affect outcomes or safety, including hypertension, heart failure, ischemic heart disease, arrhythmia, cerebrovascular disease, chronic kidney disease, diabetes, liver disease, inflammatory bowel disease, irritable bowel syndrome, or chronic constipation; (2) regular use of antihypertensives, diuretics, laxatives, antidiarrheals, corticosteroids, NSAIDs, or continued use of medications, supplements, dietary fiber products, or foods that may affect blood pressure, body fluid volume, bowel habits, electrolytes, or glucose variability; (3) severe food allergy, prior anaphylaxis, or restriction to allergens in the study foods; (4) pregnancy, possible pregnancy, breastfeeding, or plans for pregnancy during the study; (5) difficulty with blood sampling or substantial sampling-related health risk as judged by an investigator; (6) skin disease, wounds, excessive sweating, severe atopic dermatitis, or severe adhesive/medical-tape dermatitis or allergy preventing upper-arm sensor placement; (7) implanted medical devices such as pacemakers, or planned MRI, CT, X-ray, or other procedures requiring sensor removal during an intervention period and preventing adequate CGM data collection; (8) inability to comply with the study diet or measurements because of dietary restrictions, travel, work schedules, or other circumstances; or (9) any other reason judged by an investigator to make participation inappropriate. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 01 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2026 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071586

Disclaimer: Curated by HT Syndication.