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A verification study of the effect of energy metabolism improvement by consumption of Bifidobacterium animalis subsp. lactis GCL2505 and inulin

A verification study of the effect of energy metabolism improvement by consumption of Bifidobacterium animalis subsp. lactis GCL2505 and inulinbasal metabolism: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the effect of energy metabolism improvement by consumption of Bifidobacterium animalis subsp. lactis GCL2505 and inulin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052686
Enrollment
40
Registered
2024-12-17
Start date
2023-11-06
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 subjects

Interventions

Duration: Four weeks Test beverage: Milk beverage containing 10 billion Bifidobacterium animalis subsp. lactis GCL2505 and 2 g of inulin Administration: Take one bottle (100 g) once daily after brea

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women aged 25 or more and 60 or less 2) Subjects whose BMI are 25 kg/m2 or more and less than 30 kg/m2 at screening 3) Fully informed of the purpose and content of the study, deemed to have the capacity to consent, and volunteered of their own accord to participate in the study based on a thorough understanding of the purpose and content of the study, and provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1)Subjects who are undergoing medical treatment of chronic diseases 2)Treatment for severe kidney disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal gland disease, other metabolic diseases, diabetes, or other illness (excluding transient illnesses such as colds) 3)use of antibiotics within 1 month prior to the start of the study 4)regularly use intestinal drugs and laxatives (including strong laxatives) 5)unable to stop intake of health foods or supplements that affect energy metabolism 6)unable to restrict the intake of foods that might affect the intestinal microbiota 7)Who regularly consume yogurt, lactic fermenting beverages, and foods with intestinal function (those who can discontinue consumption from the screening test to the end of the study are allowed), and those who cannot stop consuming probiotics, fermented foods, and foods containing high amounts of oligosaccharides. 8)who cannot abstain from alcohol for 2 days prior to each test. 9)who are unable to fast for 12 hours prior to the metabolic rate measurement or are unable to consume 3 meals of the prescribed foods. 10)who cannot have a stool sample taken during the specified period or cannot arrange for shipping. 11)Smokers 12)history of allergy to any of the study food ingredients 13)current or former drug or alcohol dependence 14)Shift workers or late-night workers 15)who exercise regularly (about 60 minutes per week of breathless and sweaty exercise) 16)who have a cardiac pacemaker, implantable cardioverter-defibrillator, or who have metal in the measurement site due to surgery, etc. 17)who are pregnant, lactating, or planning to become pregnant during this trial 18)who are participating, or intend to participate during the study period, in a study involving the ingestion of other foods or the use of drugs, or the application of cosmetics or drugs. 19)deemed ineligible by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Resting energy expenditure at four weeks after consumption (4w)

Secondary

MeasureTime frame
1. Resting energy expenditure at two weeks after consumption (2w) 2. Respiratory quotient, energy expenditure, muscle mass, skeletal muscle mass, body fat percentage, body fat mass, acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid, and fecal Bifidobacterium at 2w and 4w

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

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