The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Species of Lactobacillus; Dietary Supplement: lactose

• Registration Number: NCT02448940
• Lead Sponsor: Urmia University of Medical Sciences

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.

Study Timeline

• Study Start: 2014-02
• Status Verified: 2014-06
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-16
• Last Update Submitted: 2015-05-16
• Study First Posted: 2015-05-20
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Species of Lactobacillus	Species of Lactobacillus	2 capsule/day of Lactofem Containing Species of Lactobacillus
lactose	lactose	2 capsule/day Containing lactose

Primary Outcome Measures

Name	Time	Method
weight change	Change from Baseline in body weight at 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

sardrood Clinic; 🇮🇷 Tabriz, Iran, Islamic Republic of