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A Randomized Open-Label Crossover Trial on the Effects of Pre-Meal Intake of Fermented Foods on Dietary Intake.

A Randomized Open-Label Crossover Trial on the Effects of Pre-Meal Intake of Fermented Foods on Dietary Intake. - A Randomized Open-Label Crossover Trial on the Effects of Pre-Meal Intake of Fermented Foods on Dietary Intake.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060309
Enrollment
20
Registered
2026-01-11
Start date
2026-01-19
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

None

Interventions

Taking fermented food once before meals Not taking fermented food before meals

Sponsors

KSO corporation
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1)Women aged between 20 and 34 years old at the time of consent acquisition. (2)BMI ranging from 18.5 kg/m2 to < 25 kg/m2. (3)Persons who have been sufficiently informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a thorough understanding of the purpose and content of the study, and have given their consent to participate in the study in writing.

Exclusion criteria

Exclusion criteria: (1)Persons with a current or past medical history of severe liver dysfunction, kidney disease, cardiovascular disorders, respiratory disorders, endocrine disorders, metabolic disorders, digestive disorders, eating disorders, or taste disorders. (2)Persons with digestive disorders affecting digestion and absorption, or a history of digestive tract surgery (excluding appendicitis). (3)Persons regularly taking prescription drugs or quasi-drugs. (4)Persons unable to discontinue consumption of health foods (including foods for specified health uses and foods with functional claims) or supplements during the trial period. (5)Persons not consuming three regular meals per day. (6)Persons with food allergies. (7)Persons who habitually engage in severe selective eating or dietary restrictions. (8)Persons who have difficulty consuming test foods and prescribed meals. (9)Pregnant persons, persons planning to become pregnant during the trial period, and persons who are breastfeeding. (10)Persons with irregular menstrual cycles. (11)Persons with irregular work schedules, such as shift work or night work. (12)Persons with a current or past history of drug dependence or alcohol dependence. (13)Persons with a history of smoking. (14)Persons who have participated in trials involving other drugs or foods within the past month, or who intend to participate in such trials. (15)Persons deemed unsuitable as subjects by the principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Dietary Content (Nutrient Intake, Total Energy Intake, Energy-Producing Nutrient Balance, Intake by Food Group, Prescribed Meal Sequence).

Secondary

MeasureTime frame
Appetite (hunger, fullness, prospective food consumption, satiety), Preference, Well-being, Sleepiness.

Countries

Japan

Contacts

Public ContactEriko Yokoshima

KSO Corporation Clinical Trial Management department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026