NCT02448940CompletedNot Applicable
The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements, Body Composition, Appetite and Serum Lipid Profile in Overweight and Obese Adults
Urmia University of Medical Sciences1 site in 1 country72 target enrollmentStarted: February 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- weight change
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
weight change
Time Frame: Change from Baseline in body weight at 12 weeks
Secondary Outcomes
- defecation(Baseline,4 weeks, 8 weeks, 12 weeks)
- blood pressure(Baseline,12 weeks)
- Anthropometric Measurement BMI(Baseline,4 weeks, 8 weeks, 12 weeks)
- Anthropometric Measurement WC(Baseline,12 weeks)
- Anthropometric Measurement HC(Baseline,12 weeks)
- Appetite(Baseline,4 weeks, 8 weeks, 12 weeks)
- Anthropometric Measurement WHR(Baseline,12 weeks)
- mid arm circumference Measurement(Baseline,12 weeks)
- Serum Lipid Profile(Baseline,12 weeks)
- skinfold thickness(Baseline,12 weeks)
- body fat percent(Baseline,12 weeks)
Investigators
Study Sites (1)
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