Abdominal ObesityNCT06320782
Effects of Different Dietary Interventions on Abdominal Fat Components, Quadriceps Muscles and Cardiometabolic Parameters
A study testing Calorie restriction and balanced distribution of macronutrients, Calorie restriction and low-carbohydrate diet and Calorie restriction and low-fat diet in people with Abdominal Obesity and Cardiac Disease, run by University of Pernambuco at 1 site in Brazil.
Trial summary
The study aims to evaluate the impact of different dietary interventions on body composition (abdominal fat components and quadriceps muscles) and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity, Cardiac Disease, Metabolic Disease
- What is being tested?
- Calorie restriction and balanced distribution of macronutrients, Calorie restriction and low-carbohydrate diet and Calorie restriction and low-fat diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Aug 2021to Dec 2025
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals of both sexes, aged ≥20 years, Body Mass Index (BMI) ≥25kg/m², attended at the general Nutrition outpatient clinic of a public university hospital reference in cardiology.
Who cannot join
- Malnourished and eutrophic individuals;
- Individuals with liver disease and/or splenomegaly, ascites, or with recent abdominal surgery;
- Pregnant women and women who had children up to 6 months prior to the survey screening;
- Individuals with consumptive diseases whose weight loss may be a consequence;
- Individuals with hypothyroidism or hyperthyroidism, on pharmacological therapy for weight loss and/or on hormone therapy;
- Individuals with mental or psychological illnesses that may make it difficult to understand dietary guidelines;
- Individuals with physical limitations that made it impossible to carry out the anthropometric and abdominal adipose tissue evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Dietary Interventions on Abdominal Fat Components, Quadriceps Muscles and Cardiometabolic Parameters: a Randomized Clinical Trial
The study aims to evaluate the impact of different dietary interventions on body composition (abdominal fat components and quadriceps muscles) and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample was calculated based on data from a study with the Brazilian population, with the sample size calculated as a function of a mean difference (d) in visceral adipose tissue (VAT) after the interventions, standard deviation (s) and a significance level of 5% (z). To correct eventual losses, the number was increased by 20%. Four dietary interventions will be applied in the 6-month period: group with calorie restriction and balanced distribution of macronutrients (group 1); group with calorie restriction and low-carbohydrate diet (group 2); group with calorie restriction and low-fat diet (group 3) and group with collective nutritional guidance (group 4). Patients will be followed up monthly for the first 6 months to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines, and monitor anthropometric measurements, abdominal adipose tissue, quadriceps muscles, and biochemical parameters. A reassessment will be performed at 12 months to analyze weight regain, analysis of anthropometric measurements, abdominal adipose tissue, quadriceps musculature and biochemical parameters. The evaluation of VAT, subcutaneous adipose tissue (SAT) and quadriceps musculature by ultrasound will be performed at baseline and after 3, 6 and 12 months of intervention. The present study is expected to clarify the effects that different dietary interventions produce over 3, 6 and 12 months on weight, abdominal fat deposits, quadriceps muscles and cardiometabolic parameters.
Read the detailed description
The study aims to evaluate the impact of different dietary interventions on abdominal fat components, quadriceps musculature and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample will take place by voluntary adherence, after evaluation of the eligibility criteria and signing of the Free and Informed Consent Form. The sample was calculated based on data from a study with the Brazilian population , with the sample size calculated calculated as a function of a mean difference between the initial visceral adipose tissue (VAT) concentration and after dietary intervention, obtaining a minimum sample of 100 individuals. To correct eventual losses, this number was increased by 20%, totaling a sample n of 120 individuals. Four dietary interventions will be applied: group with calorie restriction and balanced distribution of macronutrients (group 1), considering a progressive reduction of 500 to 1000 calories from the usual food intake or the recommendation of 20 calories/kg of current weight/day and distribution of macronutrients: 5% of carbohydrates, 2% of proteins and 3% of fats; group with calorie restriction and low-carbohydrate diet (group 2), considering a reduction in carbohydrate consumption and an increase in fat and protein intake, with the following proportions: 45% fat, 20% protein and 35% carbohydrate ; group with calorie restriction and low-fat diet (group 3), considering a restriction of fat consumption and an increase in carbohydrate consumption, with the following proportions: 20% fat, 15% protein and 65% carbohydrate and group with collective nutritional guidance (group 4), considering the recommendations of the Food Guide for the Brazilian Population. Patients will be followed up monthly for the first 6 months to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines, and monitor anthropometric measurements, abdominal adipose tissue, quadriceps muscles, and biochemical parameters. A reassessment will be performed at 12 months to analyze weight regain, analysis of anthropometric measurements, abdominal adipose tissue, quadriceps musculature and biochemical parameters. The evaluation of VAT, subcutaneous adipose tissue (SAT) and quadriceps musculature by ultrasound will be performed at baseline and after 3, 6 and 12 months of intervention. The weight loss will be evaluated as a percentage (%), based on the difference between the weight at the outcome and the weight at baseline. The weight regain will be calculated considering the difference between weight at outcome (at 6 months) and weight after six months of completion of the dietary intervention (at 12 months from the start of the study). The following parameters will be monitored: blood pressure, biochemical tests (leptin, adiponectin, fasting glucose, fasting insulin, glycated hemoglobin, triglycerides, total cholesterol and fractions, and C-reactive protein), anthropometric measurements (weight, height, waist circumference, and abdominal circumference), demographic variables (age, gender, schooling) and socioeconomic status. Data will be analyzed using the Statistical Package for Social Sciences - version 13.0 . In the description of the proportions, the binomial distribution will be approximated to the normal distribution by the 95% confidence interval. The proportions will be compared by the Chi-square test. Student's t-tests for paired or Wilcoxon samples will be used to compare VAT, SAT, quadriceps musculature, weight, BMI and biochemical parameters before and after the intervention of each group. To compare the changes in VAT, SAT, quadriceps musculature, anthropometric and biochemical parameters between the intervention groups, the one way or Kruskal Wallis ANOVA test will be used. Statistical significance will be established when a p<0.05 value. The present study is expected to clarify the effects that different dietary interventions produce over 3, 6 and 12 months on weight, abdominal fat deposits, quadriceps muscles and cardiometabolic parameters.
- Conditions
- Abdominal Obesity, Cardiac Disease, Metabolic Disease, Cardiometabolic Syndrome, Sarcopenia
- Being tested
- Calorie restriction and balanced distribution of macronutrients, Calorie restriction and low-carbohydrate diet, Calorie restriction and low-fat diet, Collective nutritional guidance
- Keywords
- Cardiometabolic Risk Factors, Dietetic interventions, Abdominal Obesity, sarcopenia
- Medical subject headings
- Obesity, Abdominal, Heart Diseases, Metabolic Diseases, Metabolic Syndrome, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie restriction and balanced distribution of macronutrientsBehavioural
Progressive reduction of 500 to 1000 calories from the usual food intake or the recommendation of 20 calories/kg of current weight/day and distribution of macronutrients: 5% of carbohydrates, 2% of proteins and 3% of fats
Calorie restriction and low-carbohydrate dietBehavioural
Reduction in carbohydrate consumption and an increase in fat and protein intake, with the following proportions: 45% fat, 20% protein and 35% carbohydrate
Calorie restriction and low-fat dietBehavioural
Restriction of fat consumption and an increase in carbohydrate consumption, with the following proportions: 20% fat, 15% protein and 65% carbohydrate
Collective nutritional guidanceBehavioural
Recommendations of the Food Guide for the Brazilian Population: limitation of the intake of foods with high energy density from fats and simple carbohydrates; substitution of saturated fats for unsaturated fats; exclusion of trans fat from the diet; increasing fruit and vegetable consumption to a daily minimum of 400g; increased consumption of high-fibre foods and limiting the consumption of sugars and salt.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention 1 | Experimental | Calorie restriction and balanced distribution of macronutrients Receives: Behavioral: Calorie restriction and balanced distribution of macronutrients |
| Dietary intervention 2 | Experimental | Calorie restriction and low-carbohydrate diet Receives: Behavioral: Calorie restriction and low-carbohydrate diet |
| Dietary intervention 3 | Experimental | Calorie restriction and low-fat diet Receives: Behavioral: Calorie restriction and low-fat diet |
| Dietary intervention 4 | Experimental | Collective nutritional guidance Receives: Behavioral: Collective nutritional guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness, measured in centimeters, of visceral adipose tissue and quadriceps muscles
The effects that different dietary interventions produce on visceral adipose tissue thickness and quadriceps muscles( measured en centimeters) will be evaluated
Measured: 3,6 and 12 months
Weight loss measured in kilograms
The effect of different dietary interventions produce on weight, measured in kilograms, will be evaluated
Measured: 6 months
Thickness of quadriceps muscle
Thickness, measured in centimeters, of quadriceps muscle
Measured: 3,6 and 12 months
Secondary outcomes (5)
Serum levels of fasting glucose
The effects that different dietary interventions produce in serum levels of fasting glucose ( in mg/dl).), will be evaluated.
Measured: 6 months
Serum levels of Insulin
The effects that different dietary interventions produce in serum levels of insulin in Microinternational Unit per Milliliter (μIU/mL)), will be evaluated.
Measured: 6 months
Serum levels Triglycerides
The effects that different dietary interventions produce in serum levels of triglycerides (in mg/dl), ), will be evaluated.
Measured: 6 months
Serum levels Lipid profile
The effects that different dietary interventions produce in serum levels of cholesterol (in mg/dl) , low-density lipoprotein cholesterol (LDL-C) ( in mg/dl), high-density lipoprotein cholesterol (HDL-C) ( in mg/dl), ), will be evaluated.
Measured: 6 months
Serum levels C-reactive protein (hs-CRP)
The effects that different dietary interventions produce in serum levels of C-reactive protein (hs-CRP) (in mg/dl)), will be evaluated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start23 Aug 2021
- Primary completion26 Mar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 interventions distributed in a randomized manner among 4 different groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Pernambuco
- Responsible party
- Principal investigator, Isa Galvão Rodrigues, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320782
- Sponsor's protocol ID
- 4659262
- Status last verified
- Oct 2024
- First submitted
- 17 Jan 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Souza RJ, Bray GA, Carey VJ, Hall KD, LeBoff MS, Loria CM, Laranjo NM, Sacks FM, Smith SR. Effects of 4 weight-loss diets differing in fat, protein, and carbohydrate on fat mass, lean mass, visceral adipose tissue, and hepatic fat: results from the POUNDS LOST trial. Am J Clin Nutr. 2012 Mar;95(3):614-25. doi: 10.3945/ajcn.111.026328. Epub 2012 Jan 18.
PubMed 22258266
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Dietary Interventions on Abdominal Fat Components, Quadriceps Muscles and Cardiometabolic Parameters: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06320782
- Acronym / sponsor ID
- 4659262
- Conditions
- Abdominal Obesity, Cardiac Disease, Metabolic Disease, Cardiometabolic Syndrome, Sarcopenia
- Keywords
- Cardiometabolic Risk Factors, Dietetic interventions, Abdominal Obesity, sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Collaborators
- Universidade Federal de Pernambuco
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 26 Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Mar 2024 (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.
The study aims to evaluate the impact of different dietary interventions on body composition (abdominal fat components and quadriceps muscles) and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample was calculated based on data from a study with the Brazilian population, with the sample size calculated as a function of a mean difference (d) in visceral adipose tissue (VAT) after the interventions, standard deviation (s) and a significance level of 5% (z). To correct eventual losses, the number was increased by 20%. Four dietary interventions will be applied in the 6-month period: group with calorie restriction and balanced distribution of macronutrients (group 1); group with calorie restriction and low-carbohydrate diet (group 2); group with calorie restriction and low-fat diet (group 3) and group with collective nutritional guidance (group 4). Patients will be followed up monthly for the first 6 months to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines, and monitor anthropometric measurements, abdominal adipose tissue, quadriceps muscles, and biochemical parameters. A reassessment will be performed at 12 months to analyze weight regain, analysis of anthropometric measurements, abdominal adipose tissue, quadriceps musculature and biochemical parameters. The evaluation of VAT, subcutaneous adipose tissue (SAT) and quadriceps musculature by ultrasound will be performed at baseline and after 3, 6 and 12 months of intervention. The present study is expected to clarify the effects that different dietary interventions produce over 3, 6 and 12 months on weight, abdominal fat deposits, quadriceps muscles and cardiometabolic parameters.
Detailed description
The study aims to evaluate the impact of different dietary interventions on abdominal fat components, quadriceps musculature and cardiometabolic parameters. This is a randomized clinical trial study conducted in overweight adults, selected by voluntary adherence, in an outpatient clinic of a cardiology hospital. The sample will take place by voluntary adherence, after evaluation of the eligibility criteria and signing of the Free and Informed Consent Form. The sample was calculated based on data from a study with the Brazilian population , with the sample size calculated calculated as a function of a mean difference between the initial visceral adipose tissue (VAT) concentration and after dietary intervention, obtaining a minimum sample of 100 individuals. To correct eventual losses, this number was increased by 20%, totaling a sample n of 120 individuals. Four dietary interventions will be applied: group with calorie restriction and balanced distribution of macronutrients (group 1), considering a progressive reduction of 500 to 1000 calories from the usual food intake or the recommendation of 20 calories/kg of current weight/day and distribution of macronutrients: 5% of carbohydrates, 2% of proteins and 3% of fats; group with calorie restriction and low-carbohydrate diet (group 2), considering a reduction in carbohydrate consumption and an increase in fat and protein intake, with the following proportions: 45% fat, 20% protein and 35% carbohydrate ; group with calorie restriction and low-fat diet (group 3), considering a restriction of fat consumption and an increase in carbohydrate consumption, with the following proportions: 20% fat, 15% protein and 65% carbohydrate and group with collective nutritional guidance (group 4), considering the recommendations of the Food Guide for the Brazilian Population. Patients will be followed up monthly for the first 6 months to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines, and monitor anthropometric measurements, abdominal adipose tissue, quadriceps muscles, and biochemical parameters. A reassessment will be performed at 12 months to analyze weight regain, analysis of anthropometric measurements, abdominal adipose tissue, quadriceps musculature and biochemical parameters. The evaluation of VAT, subcutaneous adipose tissue (SAT) and quadriceps musculature by ultrasound will be performed at baseline and after 3, 6 and 12 months of intervention. The weight loss will be evaluated as a percentage (%), based on the difference between the weight at the outcome and the weight at baseline. The weight regain will be calculated considering the difference between weight at outcome (at 6 months) and weight after six months of completion of the dietary intervention (at 12 months from the start of the study). The following parameters will be monitored: blood pressure, biochemical tests (leptin, adiponectin, fasting glucose, fasting insulin, glycated hemoglobin, triglycerides, total cholesterol and fractions, and C-reactive protein), anthropometric measurements (weight, height, waist circumference, and abdominal circumference), demographic variables (age, gender, schooling) and socioeconomic status. Data will be analyzed using the Statistical Package for Social Sciences - version 13.0 . In the description of the proportions, the binomial distribution will be approximated to the normal distribution by the 95% confidence interval. The proportions will be compared by the Chi-square test. Student's t-tests for paired or Wilcoxon samples will be used to compare VAT, SAT, quadriceps musculature, weight, BMI and biochemical parameters before and after the intervention of each group. To compare the changes in VAT, SAT, quadriceps musculature, anthropometric and biochemical parameters between the intervention groups, the one way or Kruskal Wallis ANOVA test will be used. Statistical significance will be established when a p<0.05 value. The present study is expected to clarify the effects that different dietary interventions produce over 3, 6 and 12 months on weight, abdominal fat deposits, quadriceps muscles and cardiometabolic parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 4 interventions distributed in a randomized manner among 4 different groups
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention 1 | Experimental | Behavioral: Calorie restriction and balanced distribution of macronutrientsCalorie restriction and balanced distribution of macronutrients |
| Dietary intervention 2 | Experimental | Behavioral: Calorie restriction and low-carbohydrate dietCalorie restriction and low-carbohydrate diet |
| Dietary intervention 3 | Experimental | Behavioral: Calorie restriction and low-fat dietCalorie restriction and low-fat diet |
| Dietary intervention 4 | Experimental | Behavioral: Collective nutritional guidanceCollective nutritional guidance |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals of both sexes, aged ≥20 years, Body Mass Index (BMI) ≥25kg/m², attended at the general Nutrition outpatient clinic of a public university hospital reference in cardiology.
Key exclusion criteria (7 listed)
- Malnourished and eutrophic individuals;
- Individuals with liver disease and/or splenomegaly, ascites, or with recent abdominal surgery;
- Pregnant women and women who had children up to 6 months prior to the survey screening;
- Individuals with consumptive diseases whose weight loss may be a consequence;
- Individuals with hypothyroidism or hyperthyroidism, on pharmacological therapy for weight loss and/or on hormone therapy;
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 |
|---|---|---|
| Calorie restriction and balanced distribution of macronutrientsProgressive reduction of 500 to 1000 calories from the usual food intake or the recommendation of 20 calories/kg of current weight/day and distribution of macronutrients: 5% of carbohydrates, 2% of proteins and 3% of fats | Behavioural | Dietary intervention 1 |
| Calorie restriction and low-carbohydrate dietReduction in carbohydrate consumption and an increase in fat and protein intake, with the following proportions: 45% fat, 20% protein and 35% carbohydrate | Behavioural | Dietary intervention 2 |
| Calorie restriction and low-fat dietRestriction of fat consumption and an increase in carbohydrate consumption, with the following proportions: 20% fat, 15% protein and 65% carbohydrate | Behavioural | Dietary intervention 3 |
| Collective nutritional guidanceRecommendations of the Food Guide for the Brazilian Population: limitation of the intake of foods with high energy density from fats and simple carbohydrates; substitution of saturated fats for unsaturated fats; exclusion of trans fat from the diet; increasing fruit and vegetable consumption to a daily minimum of 400g; increased consumption of high-fibre foods and limiting the consumption of sugars and salt. | Behavioural | Dietary intervention 4 |
Primary outcome
Thickness, measured in centimeters, of visceral adipose tissue and quadriceps muscles
Time frame: 3,6 and 12 months
The effects that different dietary interventions produce on visceral adipose tissue thickness and quadriceps muscles( measured en centimeters) will be evaluated
Weight loss measured in kilograms
Time frame: 6 months
The effect of different dietary interventions produce on weight, measured in kilograms, will be evaluated
Thickness of quadriceps muscle
Time frame: 3,6 and 12 months
Thickness, measured in centimeters, of quadriceps muscle
5 secondary outcomes
Serum levels of fasting glucose
Time frame: 6 months
Serum levels of Insulin
Time frame: 6 months
Serum levels Triglycerides
Time frame: 6 months
Serum levels Lipid profile
Time frame: 6 months
Serum levels C-reactive protein (hs-CRP)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 22258266de Souza RJ, Bray GA, Carey VJ, Hall KD, LeBoff MS, Loria CM, Laranjo NM, Sacks FM, Smith SR. Effects of 4 weight-loss diets differing in fat, protein, and carbohydrate on fat mass, lean mass, visceral adipose tissue, and hepatic fat: results from the POUNDS LOST trial. Am J Clin Nutr. 2012 Mar;95(3):614-25. doi: 10.3945/ajcn.111.026328. Epub 2012 Jan 18.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie restriction and balanced distribution of macronutrients, Calorie restriction and low-carbohydrate diet and Calorie restriction and low-fat diet in people with Abdominal Obesity and Cardiac Disease, run by University of Pernambuco 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 1 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 15 Oct 2024. 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. 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?
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?
Thickness, measured in centimeters, of visceral adipose tissue and quadriceps muscles (time frame: 3,6 and 12 months). The study lists 3 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 NCT06320782, which also lists 1 linked publication.
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 15 Oct 2024.