Study of the Efficacy of a Multispecies Probiotic Mixture in Obese Adults

A Randomized, Double-blind, Placebo-controlled Human Study to Evaluate the Efficacy and Safety of a Multispecies Probiotic Mixture in Obese Adults

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001588

Enrollment

Registered

2015-08-04

Start date

2015-07-09

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Dietary Supplement : Participantss will be given a multispecies probiotic mixture or placebo orally once a day for 12 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects aged between 19 and 75 years 2) Subjects who have a body index greater than 25kg/m2 3) Subjects who are willing to sign the informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects with a history of eating disorder (anorexia, bulimia) and depressive disorder, 2) Subjects who have taken amphetamine, cyproheptadine, phenothiazine, anorexigenic agent, orexigenic agent, or any health functional food including probiotics within 2 weeks (Inclusion: subjects who take steroid and thyroid hormone in safety capacity with principke investigator’s prediction of no changes during the trial period) 3) Subjects who check 4 points or more in the questionnaire of dietary exercise therapy 4) Subjects who underwent surgeries for weiight reduction (gastroplastia, carboxy therapy, hypotonic pharmacologic lipo-dissolusion, and Meso therapy) 5) Subjects with hypersensitivity to probiotics 6) Patients with active infection who need heavy doses of antibiotics 7) Subjects who gain 10% more weight within 6 months 8) Pregnant women, breast feeder, women planning a pregnancy and those who do not agree to use adequate contraception 9) Participants in any clinical trial within the 4 weeks prior to screening. 10) Subjects who have recieved dietary exercise therapy that can affect the body weight within the 3 months 11) Subjects which in the opinion investigator could affect preclude evaluation of response

Design outcomes

Secondary

Measure	Time frame
Change in body weight and BMI ;Change in fat mass (by BIA) ;Change in liver fat accumulation (by MRI);Change in AST and ALT;Change in presence of metabolic syndrome (abdominal obesity, TG, HDL cholesterol, blood pressure, and fasting glucose);Change in inflammatory related factors (IL-6, TNF-?, CRP, FGF-19, and LPS);Change in LDL-C and fasting insulin;Change in gut microbiota;Change in amount of fat within the liver and liver fibrosis within the elastic limit (by CAP)	—

Measure

Time frame

Change in body weight and BMI ;Change in fat mass (by BIA) ;Change in liver fat accumulation (by MRI);Change in AST and ALT;Change in presence of metabolic syndrome (abdominal obesity, TG, HDL cholesterol, blood pressure, and fasting glucose);Change in inflammatory related factors (IL-6, TNF-?, CRP, FGF-19, and LPS);Change in LDL-C and fasting insulin;Change in gut microbiota;Change in amount of fat within the liver and liver fibrosis within the elastic limit (by CAP)

—

Primary

Measure	Time frame
Change in visceral fat area (by MRI)	—

Countries

Korea, Republic of

Contacts

Public ContactDae Won Jun

Hanyang University Seoul Hospital

gongori1004@gmail.com+82-2-2290-8338

Outcome results