The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements

May 16, 2015 updated by: Urmia University of Medical Sciences

The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements, Body Composition, Appetite and Serum Lipid Profile in Overweight and Obese Adults

The investigators aimed to study the effect of supplementation with species of Lactobacillus on anthropometric measurements, body composition, appetite and serum lipid profile in overweight and obese adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Objective of This Study was Evaluating the Effect of supplementation with Species of Lactobacillus on anthropometric measurements include weight, waist and hip circumference , body composition include body fat and muscle percent, appetite measured by visual analogues scale and serum lipid profile in overweight and obese adults.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65 years
  • BMI more than 25 Kg/m2

Exclusion Criteria:

  • taking drugs that could affect weight change, including anti-diabetic drugs, lipid lowering drugs
  • endocrine,cardiovascular, thyroid, or chronic liver disease.
  • had received surgery to reduce weight
  • taking probiotics or antibiotics within one month
  • Pregnancy or lactation or menopause
  • A history of cancer
  • Heart disease - cardiovascular, pulmonary, renal and diabetes
  • A history of autoimmune disease
  • Taking certain medications such as blood pressure control, statins, insulin sensitivity enhancers
  • weight change over five percent within three months
  • change in activity or diet habit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Species of Lactobacillus
2 capsule/day of Lactofem Containing Species of Lactobacillus
Dietary supplement: Species of Lactobacillus
2 capsule a day Lactofem probiotics containing Species of Lactobacillus
Placebo Comparator: lactose
2 capsule/day Containing lactose
Dietary supplement: lactose
2 capsule a day containing lactose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight change
Time Frame: Change from Baseline in body weight at 12 weeks
Change from Baseline in body weight at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
defecation
Time Frame: Baseline,4 weeks, 8 weeks, 12 weeks
Bristol stool scale (BBS)
Baseline,4 weeks, 8 weeks, 12 weeks
blood pressure
Time Frame: Baseline,12 weeks
include systolic and diastolic blood pressure
Baseline,12 weeks
Anthropometric Measurement BMI
Time Frame: Baseline,4 weeks, 8 weeks, 12 weeks
Body Mass Index (BMI) kg/m2
Baseline,4 weeks, 8 weeks, 12 weeks
Anthropometric Measurement WC
Time Frame: Baseline,12 weeks
waist circumference (WC) measures by "cm"
Baseline,12 weeks
Anthropometric Measurement HC
Time Frame: Baseline,12 weeks
hip circumference (HC) measures by "cm"
Baseline,12 weeks
Appetite
Time Frame: Baseline,4 weeks, 8 weeks, 12 weeks
numeric analogue Scale (NAS) mm
Baseline,4 weeks, 8 weeks, 12 weeks
Anthropometric Measurement WHR
Time Frame: Baseline,12 weeks
waist to hip ratio (WHR)
Baseline,12 weeks
mid arm circumference Measurement
Time Frame: Baseline,12 weeks
Baseline,12 weeks
Serum Lipid Profile
Time Frame: Baseline,12 weeks
Baseline,12 weeks
skinfold thickness
Time Frame: Baseline,12 weeks
triceps, biceps, supra iliac and subscapular skinfold
Baseline,12 weeks
body fat percent
Time Frame: Baseline,12 weeks
Baseline,12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urmia University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 16, 2015

First Posted (Estimate)

May 20, 2015

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 16, 2015

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • umsu.rec.1393.74

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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