By InvitationNot Applicable

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

Brazil100 participantsStarted 2021-08-23

Plain-language 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.

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Thickness, measured in centimeters, of visceral adipose tissue and quadriceps muscles

Timeframe: 3,6 and 12 months

Weight loss measured in kilograms

Timeframe: 6 months

Thickness of quadriceps muscle

Timeframe: 3,6 and 12 months

Trial details

NCT IDNCT06320782

SponsorUniversity of Pernambuco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-26