The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements

Study Overview
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Species of Lactobacillus
* Dietary Supplement: lactose


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Species of Lactobacillus<br>2 capsule/day of Lactofem Containing Species of Lactobacillus | Dietary Supplement: Species of Lactobacillus<br>* 2 capsule a day Lactofem probiotics containing Species of Lactobacillus<br>|
| Placebo Comparator: lactose<br>2 capsule/day Containing lactose | Dietary Supplement: lactose<br>* 2 capsule a day containing lactose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change |  | Change from Baseline in body weight at 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, Lactobacillus, obesity, body composition