The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements

NCT ID: NCT02448940

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Species of Lactobacillus

2 capsule/day of Lactofem Containing Species of Lactobacillus

Group Type EXPERIMENTAL

Species of Lactobacillus

Intervention Type DIETARY_SUPPLEMENT

2 capsule a day Lactofem probiotics containing Species of Lactobacillus

lactose

2 capsule/day Containing lactose

Group Type PLACEBO_COMPARATOR

lactose

Intervention Type DIETARY_SUPPLEMENT

2 capsule a day containing lactose

Interventions

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Species of Lactobacillus

2 capsule a day Lactofem probiotics containing Species of Lactobacillus

Intervention Type DIETARY_SUPPLEMENT

lactose

2 capsule a day containing lactose

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Urmia University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Alizadeh, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, School of Medicine, Urmia University of Medical Sciences

Locations

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sardrood Clinic

Tabriz, , Iran

Site Status

Countries

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Iran

Other Identifiers

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umsu.rec.1393.74

Identifier Type: -

Identifier Source: org_study_id

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