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| Name | Class |
|---|---|
| Universidade Federal de Pernambuco | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention 1 | Experimental | Calorie restriction and balanced distribution of macronutrients |
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| Dietary intervention 2 | Experimental | Calorie restriction and low-carbohydrate diet |
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| Dietary intervention 3 | Experimental | Calorie restriction and low-fat diet |
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| Dietary intervention 4 | Experimental | Collective nutritional guidance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calorie restriction and balanced distribution of macronutrients | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 6 months |
| Thickness of quadriceps muscle | Thickness, measured in centimeters, of quadriceps muscle | 3,6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of fasting glucose | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isa Galvao Rodrigues | Recife | Pernambuco | 51021120 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22258266 | Background | 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. |
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4 interventions distributed in a randomized manner among 4 different groups
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The data analysis and interpretation stage will be carried out by the study coordinator, who will not have knowledge about the allocation of participants among the intervention groups
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| Calorie restriction and low-carbohydrate diet | Behavioral | 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 diet | Behavioral | Restriction of fat consumption and an increase in carbohydrate consumption, with the following proportions: 20% fat, 15% protein and 65% carbohydrate |
|
| Collective nutritional guidance | 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. |
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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 | The effects that different dietary interventions produce in serum levels of triglycerides (in mg/dl), ), will be evaluated. | 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. | 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. | 6 months |
| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D006331 | Heart Diseases |
| D008659 | Metabolic Diseases |
| D024821 | Metabolic Syndrome |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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