The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448940
• Other study ID #: umsu.rec.1393.74
• Status: Completed
• Phase: N/A
• First received: May 6, 2015
• Last updated: May 16, 2015
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2014
• Source: Urmia University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Species of Lactobacillus
2 capsule a day Lactofem probiotics containing Species of Lactobacillus
• lactose
2 capsule a day containing lactose

Locations

Country	Name	City	State
Iran, Islamic Republic of	sardrood Clinic	Tabriz

Sponsors (1)

Lead Sponsor	Collaborator
Urmia University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight change		Change from Baseline in body weight at 12 weeks	Yes
Secondary	defecation	Bristol stool scale (BBS)	Baseline,4 weeks, 8 weeks, 12 weeks	No
Secondary	blood pressure	include systolic and diastolic blood pressure	Baseline,12 weeks	Yes
Secondary	Anthropometric Measurement BMI	Body Mass Index (BMI) kg/m2	Baseline,4 weeks, 8 weeks, 12 weeks	Yes
Secondary	Anthropometric Measurement WC	waist circumference (WC) measures by "cm"	Baseline,12 weeks	Yes
Secondary	Anthropometric Measurement HC	hip circumference (HC) measures by "cm"	Baseline,12 weeks	Yes
Secondary	Appetite	numeric analogue Scale (NAS) mm	Baseline,4 weeks, 8 weeks, 12 weeks	No
Secondary	Anthropometric Measurement WHR	waist to hip ratio (WHR)	Baseline,12 weeks	Yes
Secondary	mid arm circumference Measurement		Baseline,12 weeks	Yes
Secondary	Serum Lipid Profile		Baseline,12 weeks	No
Secondary	skinfold thickness	triceps, biceps, supra iliac and subscapular skinfold	Baseline,12 weeks	No
Secondary	body fat percent		Baseline,12 weeks	Yes