Effect of continuous ingestion of Bifidobacterium and N-acetylglucosamine on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial -

Effect of continuous ingestion of Bifidobacterium and N-acetylglucosamine on VFA reduction. - A randomized, double-blind, placebo-controlled, parallel-group clinical trial - - A clinical trial to study the effect of Bifidobacterium on VFA reduction.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020434

Enrollment

100

Registered

2016-12-01

Start date

2016-01-12

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

Interventions

Test food contained Bifidbacterium and N-acetylglucosamine, 4 capsules once day for 12weeks. Control food not contained Bifidbacterium and N-acetylglucosamine, 4 capsules once a day for 12weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)BMI 25 - 30 kg/m2 2)Subjects who giving written informed consent

Exclusion criteria

Exclusion criteria: 1)Subjects who take drug including Bifidbacterium or drug having an effect on intestinal functions. 2)Subjects who consecutively take dietary supplement or food including Bifidbacterium (more than three times a week for more than half year), and can't stop those foods during the test period. 3)Subjects who consecutively take dietary supplement or food including N-acetylglucosamine (more than three times a week for more than half year), and can't stop those foods during the test period. 4)Subjects who constantly use drugs and/or Kampo preparation and/or dietary supplement affecting the body fat. 5)Subjects who have colonic disease within 10 years (except polyp or infectious colitis). 6)Subjects who take medical treatment for obesity-related disease. (glucose intolerance, dyslipidemia, hypertension, hyperuricemia, gout, coronary artery disease, cerebral infarction, fatty liver, menstrual abnormality, sleep apnea syndrome, obesity hypoventilation syndrome, orthopedic disease, obesity-related renal disease) 7)Subjects who have severe disorders in liver function and/or kidney function. 8)Subjects who have medical history of gastrointestinal surgery (gastrectomy, gastrointestinal suture, enterectomy, etc.). 9)Subjects who have allergy to medicine, shrimp, crab, milk or egg. 10)Subjects who can't discontinue dietary supplements for test period. 11)Subjects who are planned to participate in other clinical study. 12)Female with pregnancies, lactating or planning to become pregnant during the study. 13)Subjects who are judged as unsuitable for the study by the investigator for other reason.

Design outcomes

Primary

Measure	Time frame
Visceral Fat Area(VFA)	—

Secondary

Measure	Time frame
Body Weight, BMI, Subcutaneous fat area(SFA), Total fat area(TFA),Body fat percentage	—

Countries

Japan

Contacts

Public ContactIsao Takehara

Clinical Support Corporation PI Food Service Division

takehara@csc-smo.co.jp011-223-3130

Outcome results

None listed

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