- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06320782
Effects of Different Dietary Interventions on Abdominal Fat Components and Cardiometabolic Parameters.
March 18, 2024 updated by: Isa Galvão Rodrigues, University of Pernambuco
Effects of Different Dietary Interventions on Abdominal Fat Components and Cardiometabolic Parameters: a Randomized Clinical Trial.
The study aims to evaluate the impact of different dietary interventions on abdominal fat components 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 to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines and monitor anthropometric measurements and abdominal adipose tissue.
The evaluation of VAT and subcutaneous adipose tissue (SAT) by ultrasonography will be performed at baseline and after 6 months of intervention.
The present study is expected to clarify the effects that different dietary interventions produce over 6 months on abdominal fat deposits and cardiometabolic parameters.
Study Overview
Status
Enrolling by invitation
Detailed Description
The study aims to evaluate the impact of different dietary interventions on abdominal fat components 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 in the 6-month period: 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 to assess weight loss, analyze adherence to the diet therapy plan, reinforce nutritional guidelines and monitor anthropometric measurements and abdominal adipose tissue.
The evaluation of VAT and subcutaneous adipose tissue (SAT) by ultrasonography will be performed at baseline and after 6 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 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, weight, BMI and biochemical parameters before and after the intervention of each group.
To compare the changes in VAT, SAT, 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 6 months on abdominal fat deposits and cardiometabolic parameters.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
PE
-
Recife, PE, Brazil, 51021120
- Isa Galvao Rodrigues
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dietary intervention 1
Calorie restriction and balanced distribution of macronutrients
|
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
|
Experimental: Dietary intervention 2
Calorie restriction and low-carbohydrate diet
|
Reduction in carbohydrate consumption and an increase in fat and protein intake, with the following proportions: 45% fat, 20% protein and 35% carbohydrate
|
Experimental: Dietary intervention 3
Calorie restriction and low-fat diet
|
Restriction of fat consumption and an increase in carbohydrate consumption, with the following proportions: 20% fat, 15% protein and 65% carbohydrate
|
Experimental: Dietary intervention 4
Collective nutritional guidance
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Thickness, measured in centimeters, of visceral adipose tissue
Time Frame: 6 months
|
The effects that different dietary interventions produce on visceral adipose tissue thickness ( measured en centimeters) will be evaluated
|
6 months
|
Weight loss measured in kilograms
Time Frame: 6 months
|
The effect of different dietary interventions produce on weight, measured in kilograms, will be evaluated
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum levels of fasting glucose
Time Frame: 6 months
|
The effects that different dietary interventions produce in serum levels of fasting glucose ( in mg/dl).),
will be evaluated.
|
6 months
|
Serum levels of Insulin
Time Frame: 6 months
|
The effects that different dietary interventions produce in serum levels of insulin in Microinternational Unit per Milliliter (μIU/mL)), will be evaluated.
|
6 months
|
Serum levels Triglycerides
Time Frame: 6 months
|
The effects that different dietary interventions produce in serum levels of triglycerides (in mg/dl), ), will be evaluated.
|
6 months
|
Serum levels Lipid profile
Time Frame: 6 months
|
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.
|
6 months
|
Serum levels C-reactive protein (hs-CRP)
Time Frame: 6 months
|
The effects that different dietary interventions produce in serum levels of C-reactive protein (hs-CRP) (in mg/dl)), will be evaluated.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 23, 2021
Primary Completion (Actual)
December 26, 2023
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
January 17, 2024
First Submitted That Met QC Criteria
March 18, 2024
First Posted (Actual)
March 20, 2024
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4659262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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