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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053245
Enrollment
12
Registered
2023-12-27
Start date
2024-01-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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)Washou

Sponsors

APO PLUS STATION CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Blood total ketone bodies (delta AUC)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactMisaki Sakata

APO PLUS STATION CO., LTD. Clinical Operations Dept., CRO Business div.

food-contact@apoplus.co.jp03-6386-8809

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026