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A verification study of digestion and absorption property of the test food

A verification study of digestion and absorption property of the test food: a randomized, placebo-controlled, double-blind, crossover comparison trial - A verification study of digestion and absorption property of the test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045943
Enrollment
10
Registered
2021-11-01
Start date
2021-11-02
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

Healthy Japanese subjects

Interventions

Yeast protein &lt
Whey protein Administration: After taking blood samples before intake, dissolve test food (30 g) in water (200 mL) and drink within 10 minutes. *The intervention sequence is Period I to Period II
Whey protein &lt
Yeast protein Administration: After taking blood samples before intake, dissolve test food (30 g) in water (200 mL) and drink within 10 minutes. *The intervention sequence is Period I to Period I

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who have lactose intolerance 5. Subjects who have habits of strength training 6. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 7. Subjects currently taking medicines (include herbal medicines) and supplements 8. Subjects who take high-protein diets such as protein drinks or protein bars at least two times a week 9. Subjects who are allergic to medications and/or the test-food-related products (particularly milk) 10. Subjects who are pregnant, breast-feeding, and planning to become pregnant 11. Subjects who suffer from COVID-19 12. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 13. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

MeasureTime frame
1. The time to maximum concentration (Tmax) of total amino acid

Secondary

MeasureTime frame
1. The maximum blood concentration (Cmax), the incremental area under the curve (IAUC), and the measured values at each assessment point*1 of total amino acid 2. The measured values at each assessment point*1 of plasma amino acids fractionation, branched chain amino acid (BCAA), and essential amino acid for Tmax, Cmax, and IAUC 3. The measured values of the visual analogue scale (VAS) score for satiety at each assessment point*2 *1It indicates before test-food consumption, at one, two, four, and six hours after test-food consumption *2It indicates before test-food consumption, at 15, 30, 45, 60, 90, 120, and 180 minutes after test-food consumption

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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