NCT02448940

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
Last Updated

May 20, 2015

Status Verified

June 1, 2014

Enrollment Period

11 months

First QC Date

May 6, 2015

Last Update Submit

May 16, 2015

Conditions

Overweight and Obesity

Keywords

probioticsLactobacillusobesitybody composition

Outcome Measures

Primary Outcomes (1)

  • weight change

    Change from Baseline in body weight at 12 weeks

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Species of Lactobacillus

EXPERIMENTAL

2 capsule/day of Lactofem Containing Species of Lactobacillus

Dietary Supplement: Species of Lactobacillus

lactose

PLACEBO COMPARATOR

2 capsule/day Containing lactose

Dietary Supplement: lactose

Interventions

Species of LactobacillusDIETARY_SUPPLEMENT

2 capsule a day Lactofem probiotics containing Species of Lactobacillus

Species of Lactobacillus
lactoseDIETARY_SUPPLEMENT

2 capsule a day containing lactose

lactose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • BMI more than 25 Kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sardrood Clinic

Tabriz, Iran

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Lactose

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Mohammad Alizadeh, PhD

    Department of Nutrition, School of Medicine, Urmia University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 20, 2015

Study Start

February 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

May 20, 2015

Record last verified: 2014-06

Locations

IR(1)