Clinical trial

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

Invitation only · Not applicable · 1 countries · Registry ID NCT06320782

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionAbdominal Obesity, Cardiac Disease, Metabolic Disease, Cardiometabolic Syndrome, Sarcopenia

Full registry 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.

Treatments and study arms

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

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.

Primary outcomes

Thickness, measured in centimeters, of visceral adipose tissue and quadriceps muscles3,6 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 kilograms6 months

The effect of different dietary interventions produce on weight, measured in kilograms, will be evaluated

Thickness of quadriceps muscle3,6 and 12 months

Thickness, measured in centimeters, of quadriceps muscle

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Isa Galvao Rodrigues🇧🇷 Recife, Pernambuco, Brazil

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