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Completed

NCT Number: NCT02448940

The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements

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

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

sardrood Clinic

Tabriz, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Species of Lactobacillus

Dietary Supplement

2 capsule a day Lactofem probiotics containing Species of Lactobacillus

Lactose

Dietary Supplement

2 capsule a day containing lactose

Primary outcomes

  1. weight change

    Time frame: Change from Baseline in body weight at 12 weeks

Secondary outcomes

  1. defecation

    Time frame: Baseline,4 weeks, 8 weeks, 12 weeks

    Bristol stool scale (BBS)

  2. blood pressure

    Time frame: Baseline,12 weeks

    include systolic and diastolic blood pressure

  3. Anthropometric Measurement BMI

    Time frame: Baseline,4 weeks, 8 weeks, 12 weeks

    Body Mass Index (BMI) kg/m2

  4. Anthropometric Measurement WC

    Time frame: Baseline,12 weeks

    waist circumference (WC) measures by "cm"

  5. Anthropometric Measurement HC

    Time frame: Baseline,12 weeks

    hip circumference (HC) measures by "cm"

  6. Appetite

    Time frame: Baseline,4 weeks, 8 weeks, 12 weeks

    numeric analogue Scale (NAS) mm

  7. Anthropometric Measurement WHR

    Time frame: Baseline,12 weeks

    waist to hip ratio (WHR)

  8. mid arm circumference Measurement

    Time frame: Baseline,12 weeks

  9. Serum Lipid Profile

    Time frame: Baseline,12 weeks

  10. skinfold thickness

    Time frame: Baseline,12 weeks

    triceps, biceps, supra iliac and subscapular skinfold

  11. body fat percent

    Time frame: Baseline,12 weeks

Sponsors and collaborators

Lead sponsor

Urmia University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 20, 2015
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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