Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059692) titled 'Evaluation of the effect of a test food on lipid metabolism during sleep' on Nov. 10.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluate the lipid metabolism following a single ingestion of a food ingredient in men aged 20-64 years.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - A single intake of test food 1 will be administered. Following a washout period of 2 days or more, a single intake of test food 2 will be administered.
Interventions/Control_2 - A single intake of test food 2 will be administered. Following a washout period of 2 days or more, a single intake of test food 1 will be administered.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male
Key inclusion criteria - (1) Males aged 20 years or older but under 65 years at the time of consent acquisition
(2) Individuals with a BMI of 18.5 kg/m2 or higher but less than 30.0 kg/m2
(3) Individuals able to visit the designated trial site on the scheduled visit date
(4) Individuals who have fully understood the purpose and content of this trial and have provided informed consent
Key exclusion criteria - (1) Individuals with irregular lifestyles, such as those working rotating day-night shifts
(2) Individuals with a Pittsburgh Sleep Quality Index Global Rating score of 6 or higher
(3) Individuals with a Morningness-Eveningness Questionnaire score of lower than 30 or higher than 70
(4) Individuals unable to sleep while wearing an electroencephalograph
(5) Individuals unable to consume prescribed meals at designated times
(6) Individuals unable to perform fingerstick blood sampling
(7) Individuals unable to wear continuous glucose monitoring devices on the upper arm
(8) Individuals unable to remain in confined spaces for extended periods
(9) Individuals consuming more than 60 g of pure alcohol per day on average
(10) Individuals with smoking habits
(11) Individuals with irregular eating habits
(12) Individuals currently undergoing weight loss or planning to do so during the trial period
(13) Individuals regularly consume health foods or supplements that affect lipid metabolism, such as specific health foods, foods with functional claims, etc.
(14) Individuals with systolic blood pressure below 90 mmHg
(15) Individuals with abnormal electrocardiogram findings
(16) Individuals prone to constipation
(17) Individuals weighing less than 40 kg
(18) Individuals with pacemakers or electrical medical implants
(19) Individuals with dysphagia
(20) Individuals scheduled for magnetic resonance imaging during the trial period
(21) Individuals currently participating as subjects in another human trial, or within 4 weeks of completing such a trial
(22) Individuals with a current or past medical history of any of the following conditions:
A) Heart, liver, or kidney disease(including complications from other diseases)
B) Cardiovascular disease
C) Diabetes
D) Gastrointestinal disease
E) Allergy to the test food or prescribed diet
(23) Any other individual deemed unsuitable for this trial by the principal investigator or study physician
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 07 Day
Date of IRB - 2025 Year 11 Month 07 Day
Anticipated trial start date - 2025 Year 11 Month 10 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068253
Disclaimer: Curated by HT Syndication.
