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A Study on the Effect of Test Food on Appetite -A Randomized, Double-blind, Placebo-controlled, Triple-cross-over Study-

A Study on the Effect of Test Food on Appetite -A Randomized, Double-blind, Placebo-controlled, Triple-cross-over Study- - A Study on the Effect of Test Food on Appetite

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056748
Enrollment
15
Registered
2025-01-17
Start date
2025-01-18
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

Test foods high-dose, single ingestion. Wash out. Test foods low-dose, single ingestion. Wash out. Control foods, single ingestion. Test foods low-dose, single ingestion. Wash out. Control foods, sing

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy Japanese males and females aged 20 to 64 years-old. 2) Subjects who have no habit of smoking. 3) Subjects who do not habitually consume a large amounts of alcohol. 4) Subjects whose BMI are less than 30. 5) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: Subjects(who) 1) contract or have a history of serious diseases (eg, liver, kidney, digestive, heart, respiratory, endocrine, metabolic, skeletal muscle and/or tendon disease) 2) have a chronic disease and regularly use medications. 3) contract or have a surgical history of digestive disease affecting digestion and absorption. 4) have declared allergic reaction to ingredients contained in test foods or loading foods. 5) can't stop using supplements, and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims, or enriched foods or nutritional supplements which contain proteins and/or amino acids). 6) were judged as unsuitable for the current study by screening tests. 7) are diagnosed as anemic by the screening tests and unsuitable for frequent blood sampling. 8) have had diarrhea within the last 1 week prior to the screening tests. 9) can't stop drinking from 2 days before each measurement. 10) pregnant or breastfeed or planning to become pregnant during this study. 11) have a habit of skipping breakfast. 12) have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week. 13) are shiftworker and/or midnight-shift worker. 14) are under treatment for or have a history of drug addiction and/or alcoholism. 15) have donated over 200 mL of blood and/or blood components within the last 1 month or over 400 mL of blood and/or blood components within the last 3 months prior to the current study. 16) are participating in or willing to participate in other clinical studies. 17) are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Appetite (hunger, fullness, prospective consumption, satiety) score on the Japanese version of appetite sensations questionnaire using visual analogue scales (VAS) after the single ingestion.

Secondary

MeasureTime frame
The blood concentration of on appetite related hormones after the single ingestion.

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Clinical Trial Management department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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