Obesity
Conditions
Interventions
Participants will be randomly allocated with the aid of the RUNIF function in R (R core Team, v 4.1.2, Vienna, Austria) to generate the sequence of random numbers, so that it is under the custody of o
Sponsors
Univerisidade Federal de Alagoas
Univerisidade Federal de Alagoas
Eligibility
Age
19 Years to 60 Years
Inclusion criteria
Inclusion criteria: Adult individuals (19-60 years old); with the wish to lose weight; with a stable weight for at least 1 month; with obesity defined by two of the following three criteria: body mass index between 25 and 40 kg/m2, waist circumference bigger or equal to 88 cm for women and bigger or equal to 102 cm for men, body fat percentage of 35% for women and 25% for men determined by bioelectrical impedance
Exclusion criteria
Exclusion criteria: Individuals using chronic medications (anti-diabetics, anti-retrovirals, immunosuppressants, anti-depressants) or on hormone replacement; those with a condition that makes it impossible to carry out anthropometry or measure the components of energy expenditure; menopause, pregnant or lactating women; those who have already undergone any surgical intervention for weight loss
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success in losing weight: subjects will be classified by weight loss and maintenance lost after 12 months of intervention in the following groups: success: when the weight lost is greater than or equal to 10% of the initial weight; partial success: when the weight lost is greater than or equal to 5% and less than 10% of the initial weight; failure: when the weight lost is less than 5% of the initial weight. It is expected that 50% of the intervention group achieve weight loss success, while only 25% of the control group. Success in losing weight is a primary outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate postprandial energy expenditure after each measurement of resting energy expenditure, for which the participants will receive a type of test meal. Depending on the group in which the participant is allocated, he/she will receive only ultra-processed or no ultra-processed food to compose this meal. Using the method of indirect calorimetry after 75-90 minutes of the conclusion of the meal, the participant will be subjected again to the measurement of oxygen volumes. From this, it is expected that the group that will receive the test meal with ultra-processed foods will show a 10% lower increase in energy expenditure. This is a secondary outcome.;The assessment of food consumption will be through the application method of three 24-hour food recalls, which will include 2 days of the week and 1 day of the weekend. Food intake will be reported using household measurements and the Brazilian Table of Food Composition (2011), PHILIPPI (2016) and information provided by food manufacturers will be used to quantify energy and nutrients (carbohydrates, proteins, lipids and fibers). food products, in this order of preference. Based on this method, it is expected that the intervention group, at the end of the follow-up, ingests 15% less ultra-processed foods in the energy value in the reported consumption than the control group. This is a secondary outcome.;Evaluate the participants' autonomic function through heart rate variability using a heart rate monitor (Polar H10, São Paulo, Brazil) before measuring resting energy expenditure. From this, it is expected that the group that will have a meal with ultra-processed foods will show a 10% greater decrease in the RMSSD marker than the group that will consume a meal without ultra-processed foods. This is a secondary outcome.;It is expected to evaluate body composition by using the estimation by the RJL Quantum IV tetrapolar bioelectric impedance method (RJL Systems Inc., Michigan, United States of America). The resistance an | — |
Countries
Brazil
Contacts
Public ContactNassib Bueno
Univerisidade Federal de Alagoas
Outcome results
None listed