Overweight and ObesityNCT02448940
The Effect of Supplementation With Species of Lactobacillus on Anthropometric Measurements
A study testing Species of Lactobacillus and lactose in people with Overweight and Obesity, run by Urmia University of Medical Sciences at 1 site in Iran.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Species of Lactobacillus and lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIran
- Study dates
- Feb 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- BMI more than 25 Kg/m2
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Species of Lactobacillus, lactose
- Keywords
- probiotics, Lactobacillus, obesity, body composition
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Species of LactobacillusDietary supplement
2 capsule a day Lactofem probiotics containing Species of Lactobacillus
lactoseDietary supplement
2 capsule a day containing lactose
| Study group | Role | What they receive |
|---|---|---|
| Species of Lactobacillus | Experimental | 2 capsule/day of Lactofem Containing Species of Lactobacillus Receives: Dietary Supplement: Species of Lactobacillus |
| lactose | Placebo comparator | 2 capsule/day Containing lactose Receives: Dietary Supplement: lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
Measured: Change from Baseline in body weight at 12 weeks
Secondary outcomes (11)
defecation
Bristol stool scale (BBS)
Measured: Baseline,4 weeks, 8 weeks, 12 weeks
blood pressure
include systolic and diastolic blood pressure
Measured: Baseline,12 weeks
Anthropometric Measurement BMI
Body Mass Index (BMI) kg/m2
Measured: Baseline,4 weeks, 8 weeks, 12 weeks
Anthropometric Measurement WC
waist circumference (WC) measures by "cm"
Measured: Baseline,12 weeks
Anthropometric Measurement HC
hip circumference (HC) measures by "cm"
Measured: Baseline,12 weeks
Appetite
numeric analogue Scale (NAS) mm
Measured: Baseline,4 weeks, 8 weeks, 12 weeks
Anthropometric Measurement WHR
waist to hip ratio (WHR)
Measured: Baseline,12 weeks
mid arm circumference Measurement
Measured: Baseline,12 weeks
Serum Lipid Profile
Measured: Baseline,12 weeks
skinfold thickness
triceps, biceps, supra iliac and subscapular skinfold
Measured: Baseline,12 weeks
body fat percent
Measured: Baseline,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Urmia University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Alizadeh, PhD, Principal investigator, Department of Nutrition, School of Medicine, Urmia University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448940
- Sponsor's protocol ID
- umsu.rec.1393.74
- Status last verified
- Jun 2014
- First submitted
- 6 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02448940
- Acronym / sponsor ID
- umsu.rec.1393.74
- Conditions
- Overweight and Obesity
- Keywords
- probiotics, Lactobacillus, obesity, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Urmia University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Species of Lactobacillus | Experimental | Dietary Supplement: Species of Lactobacillus2 capsule/day of Lactofem Containing Species of Lactobacillus |
| lactose | Placebo comparator | Dietary Supplement: lactose2 capsule/day Containing lactose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65 years
- BMI more than 25 Kg/m2
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Species of Lactobacillus2 capsule a day Lactofem probiotics containing Species of Lactobacillus | Dietary supplement | Species of Lactobacillus |
| lactose2 capsule a day containing lactose | Dietary supplement | lactose |
Primary outcome
weight change
Time frame: Change from Baseline in body weight at 12 weeks
11 secondary outcomes
defecation
Time frame: Baseline,4 weeks, 8 weeks, 12 weeks
blood pressure
Time frame: Baseline,12 weeks
Anthropometric Measurement BMI
Time frame: Baseline,4 weeks, 8 weeks, 12 weeks
Anthropometric Measurement WC
Time frame: Baseline,12 weeks
Anthropometric Measurement HC
Time frame: Baseline,12 weeks
Appetite
Time frame: Baseline,4 weeks, 8 weeks, 12 weeks
Anthropometric Measurement WHR
Time frame: Baseline,12 weeks
mid arm circumference Measurement
Time frame: Baseline,12 weeks
Serum Lipid Profile
Time frame: Baseline,12 weeks
skinfold thickness
Time frame: Baseline,12 weeks
body fat percent
Time frame: Baseline,12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Alizadeh, PhD principal investigator
Department of Nutrition, School of Medicine, Urmia University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Species of Lactobacillus and lactose in people with Overweight and Obesity, run by Urmia University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight change (time frame: Change from Baseline in body weight at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.