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The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Species of Lactobacillus
lactose
Sponsored by
Urmia University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring probiotics, Lactobacillus, obesity, body composition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • sardrood Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Species of Lactobacillus

lactose

Arm Description

2 capsule/day of Lactofem Containing Species of Lactobacillus

2 capsule/day Containing lactose

Outcomes

Primary Outcome Measures

weight change

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2015
Last Updated
May 16, 2015
Sponsor
Urmia University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02448940
Brief Title
The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements
Official Title
The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements, Body Composition, Appetite and Serum Lipid Profile in Overweight and Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urmia University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
probiotics, Lactobacillus, obesity, body composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Species of Lactobacillus
Arm Type
Experimental
Arm Description
2 capsule/day of Lactofem Containing Species of Lactobacillus
Arm Title
lactose
Arm Type
Placebo Comparator
Arm Description
2 capsule/day Containing lactose
Intervention Type
Dietary Supplement
Intervention Name(s)
Species of Lactobacillus
Intervention Description
2 capsule a day Lactofem probiotics containing Species of Lactobacillus
Intervention Type
Dietary Supplement
Intervention Name(s)
lactose
Intervention Description
2 capsule a day containing lactose
Primary Outcome Measure Information:
Title
weight change
Time Frame
Change from Baseline in body weight at 12 weeks
Secondary Outcome Measure Information:
Title
defecation
Description
Bristol stool scale (BBS)
Time Frame
Baseline,4 weeks, 8 weeks, 12 weeks
Title
blood pressure
Description
include systolic and diastolic blood pressure
Time Frame
Baseline,12 weeks
Title
Anthropometric Measurement BMI
Description
Body Mass Index (BMI) kg/m2
Time Frame
Baseline,4 weeks, 8 weeks, 12 weeks
Title
Anthropometric Measurement WC
Description
waist circumference (WC) measures by "cm"
Time Frame
Baseline,12 weeks
Title
Anthropometric Measurement HC
Description
hip circumference (HC) measures by "cm"
Time Frame
Baseline,12 weeks
Title
Appetite
Description
numeric analogue Scale (NAS) mm
Time Frame
Baseline,4 weeks, 8 weeks, 12 weeks
Title
Anthropometric Measurement WHR
Description
waist to hip ratio (WHR)
Time Frame
Baseline,12 weeks
Title
mid arm circumference Measurement
Time Frame
Baseline,12 weeks
Title
Serum Lipid Profile
Time Frame
Baseline,12 weeks
Title
skinfold thickness
Description
triceps, biceps, supra iliac and subscapular skinfold
Time Frame
Baseline,12 weeks
Title
body fat percent
Time Frame
Baseline,12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Alizadeh, PhD
Organizational Affiliation
Department of Nutrition, School of Medicine, Urmia University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
sardrood Clinic
City
Tabriz
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements

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