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

NCT06320782 | Enrolling By Invitation

• 1 other identifier: 4659262
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cardiometabolic Risk Factors; Dietetic interventions; Abdominal Obesity; sarcopenia

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Serum levels of fasting glucose

  6 months

• Serum levels of Insulin

  6 months

• Serum levels Triglycerides

  6 months

• Serum levels Lipid profile

  6 months

• Serum levels C-reactive protein (hs-CRP)

  6 months

Study Arms (4)

Dietary intervention 1

EXPERIMENTAL

Calorie restriction and balanced distribution of macronutrients

Behavioral: Calorie restriction and balanced distribution of macronutrients

Dietary intervention 2

EXPERIMENTAL

Calorie restriction and low-carbohydrate diet

Behavioral: Calorie restriction and low-carbohydrate diet

Dietary intervention 3

EXPERIMENTAL

Calorie restriction and low-fat diet

Behavioral: Calorie restriction and low-fat diet

Dietary intervention 4

EXPERIMENTAL

Collective nutritional guidance

Behavioral: Collective nutritional guidance

Interventions

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

Dietary intervention 1

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

Dietary intervention 2

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

Dietary intervention 3

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.

Dietary intervention 4

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pernambuco: lead
• Universidade Federal de Pernambuco: collaborator

Study Sites (1)

Isa Galvao Rodrigues

Recife, Pernambuco, 51021120, Brazil

Location

Related Publications (1)

• 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.

  PMID: 22258266 BACKGROUND

MeSH Terms

Conditions

Obesity, Abdominal; Heart Diseases; Metabolic Diseases; Metabolic Syndrome; Sarcopenia

Interventions

Diet, Carbohydrate-Restricted; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 4 interventions distributed in a randomized manner among 4 different groups

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: March 20, 2024
• Study Start: August 23, 2021
• Primary Completion: March 26, 2025
• Study Completion: December 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)