Effects of Different Dietary Interventions on Abdominal Fat Components, Quadriceps Muscles and Cardiometabolic Parameters

NCT ID: NCT06320782

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2025-12-31

Brief 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 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.

Conditions

Abdominal Obesity; Cardiac Disease; Metabolic Disease; Cardiometabolic Syndrome; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Dietary intervention 1

Calorie restriction and balanced distribution of macronutrients

Group Type: EXPERIMENTAL

Calorie restriction and balanced distribution of macronutrients

Intervention Type: BEHAVIORAL

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

Dietary intervention 2

Calorie restriction and low-carbohydrate diet

Group Type: EXPERIMENTAL

Calorie restriction and low-carbohydrate diet

Intervention Type: BEHAVIORAL

Reduction in carbohydrate consumption and an increase in fat and protein intake, with the following proportions: 45% fat, 20% protein and 35% carbohydrate

Dietary intervention 3

Calorie restriction and low-fat diet

Group Type: EXPERIMENTAL

Calorie restriction and low-fat diet

Intervention Type: BEHAVIORAL

Restriction of fat consumption and an increase in carbohydrate consumption, with the following proportions: 20% fat, 15% protein and 65% carbohydrate

Dietary intervention 4

Collective nutritional guidance

Group Type: EXPERIMENTAL

Collective nutritional guidance

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: collaborator

University of Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Isa Galvão Rodrigues

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Isa Galvao Rodrigues

Recife, Pernambuco, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 22258266 (View on PubMed)

Other Identifiers

4659262

Identifier Type: -

Identifier Source: org_study_id