ObesityPhase 2NCT05676229
Probiotic Blend in Reducing Anthropometric Measurements in Obese Adults
A Phase 2 study testing Probiotic blend in people with Obesity and Obesity; Endocrine, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
Trial summary
It is already known that dysbiosis, that is, qualitative and quantitative changes in the composition of the intestinal microbiota, can be associated with the development of a series of intestinal and extra-intestinal disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Obesity; Endocrine, Overweight and Obesity
- What is being tested?
- Probiotic blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteBrazil
- Study dates
- 11 Jan 2023to 30 Dec 2023
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of Free and Informed Consent in writing, signed and dated;
- Age according to the indicated population (18-65 years old)
- both genders;
- Body mass index (BMI) of 25 - 35 Kg/m2.
Who cannot join
- Pregnant and lactating women
- Individuals with a history of daily consumption of probiotics, fermented milk and/or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product;
- Individuals with concomitant participation in another clinical trial;
- History of autoimmune, cardiovascular, thyroid, or chronic liver disease;
- Making use of medication capable of affecting weight change, antidiabetic medication, hypolipidemic agents;
- Individuals who have undergone weight loss surgery,
- Weight change greater than 5% in the last three months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade do Extremo Sul Catarinense
Criciúma, Santa Catarina, 88806-000
Monique Michels, +55 48 996274651, monique@biohall.com.br
About this study
Official title: The Use of a Probiotic Blend in Reducing Anthropometric Measurements and Improving Biochemical Parameters in Adults With Overweight and/or Obese
It is already known that dysbiosis, that is, qualitative and quantitative changes in the composition of the intestinal microbiota, can be associated with the development of a series of intestinal and extra-intestinal disorders. Dysbiosis is reported in irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, allergic diseases, non-alcoholic steatohepatitis, arteriosclerotic diseases, neurological diseases and metabolic syndromes, mainly diabetes and obesity. Among the many factors that play a key role in obesity, a number of studies show the intestinal microbiota as an important contributor. Many studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of obesity. Furthermore, it is found that benefits for body weight, abdominal adiposity, anthropometric measurements and body composition are often associated with favorable metabolic effects.
Read the detailed description
Obesity is defined as excessive accumulation of body fat, caused by an energy imbalance. Approximately 13% of the world's adult population is obese, and in Brazil 19.8% of adults are obese. This disease is a risk factor for the development of other non-communicable chronic diseases (NCDs), such as: type 2 diabetes mellitus (DM2), dyslipidemia, cardiovascular diseases, musculoskeletal disorders and some types of cancer. It is a complex and multifactorial disease, which is why it is considered difficult to control and a cause for global concern. Among the causes of the disease, genetic, environmental and psychological factors can be mentioned, in addition to the interference of the intestinal microbiota, among others.
The interaction of the intestinal microbiota with the host has been studied through metabolomics, in order to understand the influence that the microbiota can exert on the functioning of the host organism. The study of the profile of low molecular weight metabolites of biological fluids such as serum/plasma and urine aims to understand the metabolic changes that occur in individuals with obesity, encompassing the understanding of the mechanisms of the disease.
Studies have shown differences in the metabolic profile of obese individuals compared to eutrophic individuals, with a positive correlation between body mass index (BMI) and increased concentrations of chain amino acids (BCAA) and glutamate. The gut microbiota appears to play a crucial role in host metabolism, being a pathway through which it leads to changes associated with obesity.
In this context, the intestinal microbiota can be modulated by prebiotics, probiotics and symbiotics, promoting changes in its composition, resulting in the regeneration of the intestinal barrier and, with that, ceasing metabolic endotoxemia and low-grade inflammation.
In addition, they have effects on the modulation of the immune system, regulating the production of pro and anti-inflammatory cytokines, reducing IR. Through these mechanisms, probiotics and symbiotics alter the microbiota profile of individuals leading to loss of body weight and metabolic parameters associated with obesity.
Several studies have shown beneficial effects of using probiotics on body weight, glycemic control, improvement in lipid profile and blood pressure (BP). However, there are controversies about which are the best strains for this purpose. There are five systematic reviews currently published with or without meta-analysis that address the effect of using different probiotics on body weight. Among the strains associated with weight loss and/or adiposity, L. plantarum associated with L. rhamnosus and hypocaloric diet stand out; L. plantarum with L. curvatus; L. gasseri; L. amylovorus; L. acidophilus and L. casei associated with phenolic compounds; or Lactobacillus mix.
- Conditions
- Obesity, Obesity; Endocrine, Overweight and Obesity, Overweight, Obesity and Other Hyperalimentation
- Being tested
- Probiotic blend, Placebo
- Keywords
- obesity, probiotic, supplement
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic blendDietary supplement
Lactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858
PlaceboDietary supplement
Maltodextrin only (vehicle)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Volunteers supplemented with maltodextrin Receives: Dietary Supplement: Placebo |
| Probiotic Blend | Active comparator | Lactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858 - Final concentration: 1 x 10e10 UFC/ day Receives: Dietary Supplement: Probiotic blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat composition by Bioelectrical impedance analysis
By Bioelectrical impedance analysis (BIA). This is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body.
Measured: three months
Secondary outcomes (9)
Total cholesterol by blood analyses
biochemical analyses before and after inclusion: Total cholesterol to be carried out in a reference laboratory. Total cholesterol will be measured in mg/dL
Measured: three months
quality of life questionnaire score
quality of life and improvement of gastrointestinal symptoms by SF-36 scale (It comprises 36 questions that cover eight domains of health)
Measured: three months
Gastrointestinal Symptom Rating Scale (GSRS) questionnaire score
GSRS scale: An interview-based rating scale consisting of 15 items for assessment of gastrointestinal symptoms
Measured: three months
Weight
weight will be measured in kilograms
Measured: three months
height
height will be measured in centimeters
Measured: three months
HDL levels by blood analyses
biochemical analyses before and after inclusion: HDL to be carried out in a reference laboratory. HDL will be measured in mg/dL
Measured: three months
LDL levels by blood analyses
biochemical analyses before and after inclusion: LDL to be carried out in a reference laboratory. LDL will be measured in mg/dL
Measured: three months
triglycerides levels by blood analyses
biochemical analyses before and after inclusion: triglycerides to be carried out in a reference laboratory. triglycerides will be measured in ml/dL
Measured: three months
Glucose levels by blood analyses
biochemical analyses before and after inclusion: glucose to be carried out in a reference laboratory. glucose will be measured in mg/dL
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start11 Jan 2023
- Primary completion19 Feb 2023
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, triple-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monique Michels, Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676229
- Sponsor's protocol ID
- 65117022.1.0000.0119
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Probiotic Blend in Reducing Anthropometric Measurements and Improving Biochemical Parameters in Adults With Overweight and/or Obese
- ClinicalTrials.gov ID
- NCT05676229
- Acronym / sponsor ID
- 65117022.1.0000.0119
- Conditions
- Obesity, Obesity; Endocrine, Overweight and Obesity, Overweight, Obesity and Other Hyperalimentation
- Keywords
- obesity, probiotic, supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudeUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 19 Feb 2023 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 9 Jan 2023 (actual)
- 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.
It is already known that dysbiosis, that is, qualitative and quantitative changes in the composition of the intestinal microbiota, can be associated with the development of a series of intestinal and extra-intestinal disorders. Dysbiosis is reported in irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, allergic diseases, non-alcoholic steatohepatitis, arteriosclerotic diseases, neurological diseases and metabolic syndromes, mainly diabetes and obesity. Among the many factors that play a key role in obesity, a number of studies show the intestinal microbiota as an important contributor. Many studies carried out with probiotics have shown that their administration can be effective in the prevention and treatment of obesity. Furthermore, it is found that benefits for body weight, abdominal adiposity, anthropometric measurements and body composition are often associated with favorable metabolic effects.
Detailed description
Obesity is defined as excessive accumulation of body fat, caused by an energy imbalance. Approximately 13% of the world's adult population is obese, and in Brazil 19.8% of adults are obese. This disease is a risk factor for the development of other non-communicable chronic diseases (NCDs), such as: type 2 diabetes mellitus (DM2), dyslipidemia, cardiovascular diseases, musculoskeletal disorders and some types of cancer. It is a complex and multifactorial disease, which is why it is considered difficult to control and a cause for global concern. Among the causes of the disease, genetic, environmental and psychological factors can be mentioned, in addition to the interference of the intestinal microbiota, among others.
The interaction of the intestinal microbiota with the host has been studied through metabolomics, in order to understand the influence that the microbiota can exert on the functioning of the host organism. The study of the profile of low molecular weight metabolites of biological fluids such as serum/plasma and urine aims to understand the metabolic changes that occur in individuals with obesity, encompassing the understanding of the mechanisms of the disease.
Studies have shown differences in the metabolic profile of obese individuals compared to eutrophic individuals, with a positive correlation between body mass index (BMI) and increased concentrations of chain amino acids (BCAA) and glutamate. The gut microbiota appears to play a crucial role in host metabolism, being a pathway through which it leads to changes associated with obesity.
In this context, the intestinal microbiota can be modulated by prebiotics, probiotics and symbiotics, promoting changes in its composition, resulting in the regeneration of the intestinal barrier and, with that, ceasing metabolic endotoxemia and low-grade inflammation.
In addition, they have effects on the modulation of the immune system, regulating the production of pro and anti-inflammatory cytokines, reducing IR. Through these mechanisms, probiotics and symbiotics alter the microbiota profile of individuals leading to loss of body weight and metabolic parameters associated with obesity.
Several studies have shown beneficial effects of using probiotics on body weight, glycemic control, improvement in lipid profile and blood pressure (BP). However, there are controversies about which are the best strains for this purpose. There are five systematic reviews currently published with or without meta-analysis that address the effect of using different probiotics on body weight. Among the strains associated with weight loss and/or adiposity, L. plantarum associated with L. rhamnosus and hypocaloric diet stand out; L. plantarum with L. curvatus; L. gasseri; L. amylovorus; L. acidophilus and L. casei associated with phenolic compounds; or Lactobacillus mix.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, triple-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboVolunteers supplemented with maltodextrin |
| Probiotic Blend | Active comparator | Dietary Supplement: Probiotic blendLactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858 - Final concentration: 1 x 10e10 UFC/ day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of Free and Informed Consent in writing, signed and dated;
- Age according to the indicated population (18-65 years old)
- both genders;
- Body mass index (BMI) of 25 - 35 Kg/m2.
Key exclusion criteria (7 listed)
- Pregnant and lactating women
- Individuals with a history of daily consumption of probiotics, fermented milk and/or yogurt; subjects known to have demonstrated a prior reaction, including anaphylaxis, to any substance in the composition of the study product;
- Individuals with concomitant participation in another clinical trial;
- History of autoimmune, cardiovascular, thyroid, or chronic liver disease;
- Making use of medication capable of affecting weight change, antidiabetic medication, hypolipidemic agents;
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 |
|---|---|---|
| Probiotic blendLactobacillus gasseri CCT 7850 and Bifidobacterium lactis CCT 7858 | Dietary supplement | Probiotic Blend |
| PlaceboMaltodextrin only (vehicle) | Dietary supplement | Placebo |
Primary outcome
Body fat composition by Bioelectrical impedance analysis
Time frame: three months
By Bioelectrical impedance analysis (BIA). This is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body.
9 secondary outcomes
Total cholesterol by blood analyses
Time frame: three months
quality of life questionnaire score
Time frame: three months
Gastrointestinal Symptom Rating Scale (GSRS) questionnaire score
Time frame: three months
Weight
Time frame: three months
height
Time frame: three months
HDL levels by blood analyses
Time frame: three months
LDL levels by blood analyses
Time frame: three months
triglycerides levels by blood analyses
Time frame: three months
Glucose levels by blood analyses
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic blend in people with Obesity and Obesity; Endocrine, run by Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude at 1 site in Brazil.
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 4 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 21 Feb 2023. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat composition by Bioelectrical impedance analysis (time frame: three months). 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 21 Feb 2023.