NCT00880958

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

First QC Date

April 13, 2009

Last Update Submit

October 28, 2009

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    16 weeks

Secondary Outcomes (7)

  • Body fat mass

    Week -4, Week 0, Week 4, Week 12

  • Abdominal circumference

    Week -4, Week 0, Week 4, Week 12

  • Visceral fat area by CT scan

    Week 0, Week 12

  • Intestinal flora

    Week 0, Week 12

  • Serum lipid profile

    Week -4, Week 0, Week 4, Week 12

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: Mixture of various probiotics and fermentation products

2

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Mixture of various probiotics and fermentation productsDIETARY_SUPPLEMENT
1
PlaceboDIETARY_SUPPLEMENT
2

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, Hiroshima, 734-8551, Japan

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2009

First Posted

April 14, 2009

Study Start

March 1, 2009

Study Completion

September 1, 2009

Last Updated

October 29, 2009

Record last verified: 2009-10

Locations

JP(1)