Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity

Hiroshima University30 enrolled

Overview

The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

Mixture of various probiotics and fermentation productsDIETARY_SUPPLEMENT

PlaceboDIETARY_SUPPLEMENT

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy as based on medical history and physical examination * BMI between 25 and 30 kg/m2 * Willing not to serve as blood donor during the study * Informed consent signed Exclusion Criteria: * Food allergy * Female subjects who are pregnant or nursing a child * Participation in any clinical trial up to 90 days before Day 01 of this study * Renal or hepatic dysfunction * Heart disease * Under medication * Subjects who are taking functional food designed for weight loss or serum lipid reduction

Locations (1)

Hiroshima University

Hiroshima, Hiroshima, Japan

Outcomes

Primary Outcomes

Body mass index

Time frame: 16 weeks

Secondary Outcomes

Body fat mass

Time frame: Week -4, Week 0, Week 4, Week 12

Abdominal circumference

Time frame: Week -4, Week 0, Week 4, Week 12

Visceral fat area by CT scan

Time frame: Week 0, Week 12

Intestinal flora

Time frame: Week 0, Week 12

Serum lipid profile

Time frame: Week -4, Week 0, Week 4, Week 12

Serum adiponectin and leptin levels

Time frame: Week 0, Week 12

Fasting serum glucose and HbA1c levels

Time frame: Week -4, Week 0, Week 4, Week 12

Data from ClinicalTrials.gov

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