Tokyo, Dec. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059952) titled 'Study of measurement on body temperature for functional foods' on Dec. 3.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Non-randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - CHUSEI OIL CO., LTD.

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

Objective: Narrative objectives1 - A single-blind crossover study will be conducted to examine the time course of change in core body temperature, VAS (sleepiness, fatigue, hunger, etc.), PVT (alertness) after a single intake of macadamia nut oil using soybean oil as a control. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 2 and half of roll bread Interventions/Control_2 - 2 rolls of bread + macadamia nuts oil powder

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Those whose living environment will not change significantly during the test period Those who can visit the designated test location on the designated test date Those who can wear a core body temperature measuring device Key exclusion criteria - Those with food allergies to wheat, nuts, soybeans,dairy products etc. Those who regularly consume foods for specified health uses or foods with functional claims and are unable to stop consuming them while participating in this study period Those who regularly consume foods containing macadamia nuts oils Those who are pregnant, breastfeeding, or intend to become pregnant during the study period Those who have participated in other clinical trials in the month prior to the study period Others who the study director deems inappropriate for this study Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 09 Month 30 Day Date of IRB - 2024 Year 11 Month 25 Day Anticipated trial start date - 2025 Year 12 Month 03 Day Last follow-up date - 2026 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068520

Disclaimer: Curated by HT Syndication.