AzTrials
AzTrials

ObesityNCT04086173

Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota

A study testing Probiotics in people with Obesity and Insulin Resistance, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to evaluate the modifications in body composition and insulin resistance state in patients with grade II and III obesity included in an interventional lifestyle changes program and treated with probiotics (1 x 1011 CFU) or placebo for 16 weeks and its associations with intestinal microbiota behaviour Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Probiotics
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteMexico
Study dates
1 Mar 2018to 31 Jul 2020
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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with grade II y III obesity (IMC > or = 35 Kg/m2), who receive the initial evaluation at the Integral Attention Clinic for Diabetes and Obesity at Hospital General de México
  • Patients who signed informed consent.

Who cannot join

  • Diabetes mellitus 2
  • Secondary causes of obesity (hypothyroidism, Cushing syndrome).
  • Patients receiving pharmacological treatment that may affect lipid or glucose metabolism.
  • Patients who received broad-spectrum antibiotics during the 4 previous weeks.
  • Ingestion of products that contain probiotics.
  • Relevant changes in diet habits during the 4 previous weeks
  • Intestinal Malabsorption disorders ( inflammatory bowel disease, chronic diarrhea, C. difficile infection).

Trial locations and contacts

1 site in 1 country.

Nayely Garibay, MSc contact

+525546037000

gngaribay@hotmail.com

Alejandro Velasco, MSc contact

+525541449172

jano_vm@yahoo.com

Mexico1 site, 1 recruiting

  • Hospital General de México "Dr. Eduardo Liceaga"

    Mexico City

    Alejandro Velasco Medina, MSc, 5541449172, jano_vam@yahoo.com.mx

    Recruiting

Other trials in Mexico

About this study

Official title: Effects of Probiotic Treatment on Body Composition and Insulin Resistance in Patients With Obesity Grade II and III and Its Association With Changes in Intestinal Microbiota

This study aims to evaluate the modifications in body composition and insulin resistance state in patients with grade II and III obesity included in an interventional lifestyle changes program and treated with probiotics (1 x 1011 CFU) or placebo for 16 weeks and its associations with intestinal microbiota behaviour

Read the detailed description

A randomized placebo-controlled clinical trial will take place in which both arms will be included in an interventional lifestyle changes program at the Clinic for Integral Treatment of patients with Diabetes and Obesity. The study group will be treated with probiotics (1 x 1011 CFU) for 16 weeks and will be compared to a control group who will receive placebo.

Changes in body composition (weight, BMI, fat percentage, fat mass, lean body mass) and insulin resistance indexes (HOMA, insulin sensitivity index and Quicki) will be evaluated in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group.

Changes in metabolic profile (glucose tolerance test, glycosylated haemoglobin, lipid profile, leptin and transaminases) in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group.

Changes in microRNAs profile (miR-133 and miR-27 in patients with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to a placebo group.

The threshold for basic tastes will be evaluated (salted, bitter, acid, sweet) and will be evaluated in those patients receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to the group receiving only placebo.

Changes in intestinal microbiota behaviour will be evaluated in participants with obesity receiving probiotics (1 x 1011 CFU) for 16 weeks, and compared to the group receiving placebo.

Being tested
Probiotics, Placebo
Medical subject headings
Obesity, Insulin Resistance, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticsDietary supplement

    Probiotics will be administered at night and will consist of 4 capsules

  • PlaceboOther

    Placebo

Study groups in NCT04086173
Study groupRoleWhat they receive
Study groupExperimentalSubjects will be randomly assigned to receive a daily nightly dose (4 capsules) of probiotics for 16 weeks. Probiotics (LACTIPAN®) include 2.5 billion CFU of 6 different strains of live microorganisms, such as Lactobacillus acidophilus (1.0 x 109 CFU), Lactobacillus casei (1.0 x 109 CFU), Lactobacillus rhamnosus (4.4 x 108 CFU), Lactobacillus plantarum (1.76 x 108 CFU), Bifidobacterium infantis (2.76 x 107 CFU), Streptococcus thermophilus (6.66 x 105 CFU) and 50 mg of oligofructose enriched inulin.
Receives: Dietary Supplement: Probiotics
Control groupPlacebo comparatorSubjects will be randomly assigned to receive a daily nightly dose (4 capsules) of placebo for 16 weeks. Placebo presentation will have the same aspect as those of the probiotic treatment.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in fat mass in patients with obesity

    Evaluate changes in fat mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis

    Measured: 16 weeks

  2. Changes in fat percentage in patients with obesity

    Evaluate changes in fat percentage after probiotics treatment in patients with obesity, by bioelectrical impedance analysis

    Measured: 16 weeks

  3. Changes in body mass index in patients with obesity

    Evaluate changes in body mass index after probiotics treatment in patients with obesity. Calculated with the weight in kilograms divided by the square of the height in meters

    Measured: 16 weeks

  4. Changes in weight in patients with obesity

    Evaluate changes in weight kilograms after probiotics treatment in patients with obesity

    Measured: 16 weeks

  5. Changes in lean body mass in patients with obesity

    Evaluate changes in lean body mass kilograms after probiotics treatment in patients with obesity, by bioelectrical impedance analysis

    Measured: 16 weeks

  6. Changes in Insulin resistance indexes

    Modification in HOMA index after probiotics treatment in patients with obesity

    Measured: 16 weeks

  7. Changes in Insulin sensitivity indexes

    Modification in insulin sensitivity index after probiotics treatment in patients with obesity

    Measured: 16 weeks

  8. Changes in Quicki insulin sensitivity index

    Modification in Quicki index after probiotics treatment in patients with obesity

    Measured: 16 weeks

Secondary outcomes (10)

  1. Changes in glucose tolerance test

    Evaluate changes in glucose tolerance test after treatment with probiotics in patients with obesity. By using plasma concentrations of insulin and glucose obtained during 120 min of a standard (75 g glucose).

    Measured: 16 weeks

  2. Changes in glycated haemoglobin

    Evaluate changes in percentage glycated haemoglobin after treatment with probiotics in patients with obesity. Obtain by capillary electrophoresis system

    Measured: 16 weeks

  3. Changes in triglycerides

    Evaluate changes in triglycerides (mg/dL) after treatment with probiotics in patients with obesity

    Measured: 16 weeks

  4. Changes in total cholesterol

    Evaluate changes in total cholesterol (mg/dL) after treatment with probiotics in patients with obesity

    Measured: 16 weeks

  5. Changes in HDL cholesterol

    Evaluate changes in HDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity

    Measured: 16 weeks

  6. Changes in LDL cholesterol

    Evaluate changes in LDL cholesterol (mg/dL) after treatment with probiotics in patients with obesity

    Measured: 16 weeks

  7. Changes in uric acid

    Evaluate changes in uric acid (mg/dL) after treatment with probiotics in patients with obesity

    Measured: 16 weeks

  8. Changes in aspartate aminotransferase

    Evaluate changes in aspartate aminotransferase (U/L) after treatment with probiotics in patients with obesity

    Measured: 16 weeks

  9. Changes in alanine aminotransferase

    Evaluate changes in alanine aminotransferase (U/L) after treatment with probiotics in patients with obesity

    Measured: 16 weeks

  10. Changes in leptin

    Evaluate changes in leptin (ng/mL) after treatment with probiotics in patients with obesity

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2019
  2. Study start1 Mar 2018
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion31 Jul 2020 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blinded randomized placebo-controlled clinical assay
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04086173
Sponsor's protocol ID
00000
Status last verified
Sep 2019
First submitted
5 Mar 2019
Last updated
11 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Banegas JR, Lopez-Garcia E, Gutierrez-Fisac JL, Guallar-Castillon P, Rodriguez-Artalejo F. A simple estimate of mortality attributable to excess weight in the European Union. Eur J Clin Nutr. 2003 Feb;57(2):201-8. doi: 10.1038/sj.ejcn.1601538.

    PubMed 12571650

  • Neish AS. Microbes in gastrointestinal health and disease. Gastroenterology. 2009 Jan;136(1):65-80. doi: 10.1053/j.gastro.2008.10.080. Epub 2008 Nov 19.

    PubMed 19026645

  • Hooper LV, Wong MH, Thelin A, Hansson L, Falk PG, Gordon JI. Molecular analysis of commensal host-microbial relationships in the intestine. Science. 2001 Feb 2;291(5505):881-4. doi: 10.1126/science.291.5505.881.

    PubMed 11157169

  • Jalanka J, Mattila E, Jouhten H, Hartman J, de Vos WM, Arkkila P, Satokari R. Long-term effects on luminal and mucosal microbiota and commonly acquired taxa in faecal microbiota transplantation for recurrent Clostridium difficile infection. BMC Med. 2016 Oct 11;14(1):155. doi: 10.1186/s12916-016-0698-z.

    PubMed 27724956

  • Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3. doi: 10.1038/4441022a.

    PubMed 17183309

Questions about this trial

What is this clinical trial studying?

A study testing Probiotics in people with Obesity and Insulin Resistance, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.

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 7 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: status not confirmed, as of the sponsor's last update on 11 Sep 2019. 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 Mexico. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nayely Garibay, MSc (+525546037000, gngaribay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in fat mass in patients with obesity (time frame: 16 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04086173, which also lists 5 linked publications.

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 11 Sep 2019.

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