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Exploratory study on the effect of food material processing on the absorption of functional lipids

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Not applicable
Date of first enrollment	2024/01/15
Target sample size	12
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	1)Single intake of placebo (control food) 2)Washout period is for more than 6 days 3)Single intake of reference food 4)Washout period is for more than 6 days 5)Single intake of test food 6)Washout period is for more than 6 days 7)Single intake of placebo (control food) 1)Single intake of placebo (control food) 2)Washout period is for more than 6 days 3)Single intake of reference food 4)Washout period is for more than 6 days 5)Single intake of placebo (control food) 6)Washout period is for more than 6 days 7)Single intake of test food

Outcome(s)

Primary Outcome	Blood total ketone bodies (delta AUC)
Secondary Outcome	blood metabolites, metabolic markers (AUC, delta AUC, Cmax, delta Cmax, Tmax) blood ketone bodies (beta-Hydroxybutyric acid, acetoacetic acid, and the total value) medium-chain fatty acid (octanoic acid, decanoic acid) acyl-ghrelin and des-acyl ghrelin Glucose insulin abdominal symptoms questionnaire Rating scale about gastralgia, epigastric fullness, nausea bloating, appetite for the foods

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	40years-old
Gender	Male
Include criteria	1) Subjects who have been fully informed of the purpose and content of the study, have the capacity to consent, volunteer of their own free will with full knowledge of the content, and consent to participate in the study 2) Males in the age between 20 and 40 years 3) Subjects whose BMI 18.5 kg/m2 or more and less than 25.0 kg/m2
Exclude criteria	1)Subjects who routinely take pharmaceuticals, quasi-drugs, dietary supplement, foods for specified health uses, medium-chain triglycerides or coconut oil for more than two days per week within a month before the screening test 2)Subjects judged by the principal investigator to have serious chronic illnesses or symptoms 3)Subjects judged by the principal investigator to have abnormalities in lipid metabolism, sugar metabolism, liver function, or kidney function 4)Subjects who have food allergies 5)Subjects who are intolerant to lactose 6)Subjects who have had digestive system surgery 7)Subjects who smoked within a month before the screening test 8)Subjects who were donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test 9)Subjects who participated in other clinical trials within a month before the screening test or plan to participate other clinical trials during this study period 10)Subjects who are judged as ineligible for the study by the investigator