Obesity
Conditions
Interventions
This is a randomized, parallel clinical trial with two research arms. Due to the nature of the intervention, it cannot be double-blind. Participants will be randomly allocated with the aid of the stat
Sponsors
Univerisidade Federal de Alagoas
Univerisidade Federal de Alagoas
Eligibility
Age
19 Years to 60 Years
Inclusion criteria
Inclusion criteria: Individuals aged between 19 and 60, with obesity defined by 2 of the 3 following criteria: body mass index between 25 and 40 kg/m2; waist circumference greater than or equal to 88 cm for women and greater than or equal to 102 cm for men; body fat percentage greater than or equal to 35% for women and greater than or equal to 25% for men, determined by bioelectrical impedance; who want to lose weight, but who have had a stable weight for at least 1 month at the time of inclusion
Exclusion criteria
Exclusion criteria: Individuals using chronic medications (antidiabetics, antiretrovirals, immunosuppressants, antidepressants); celiac or gluten-sensitive individuals; vegetarians or vegans; who have a condition that makes it impossible to perform anthropometry or measure the components of energy expenditure; menopausal women; pregnant women or nursing mothers; or who have already undergone any surgical intervention for weight loss
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the resting energy expenditure by means of indirect calorimetry, using a gas analyzer (Fitmate RMR, COSMED, Rome, Italy). This procedure will be performed in the absence of physical exercise in the last 24 hours, after the participants have fasted for 10 hours, with only water consumption allowed. The collection site will be silent, with little lighting and at a comfortable temperature, to avoid changes caused by cold or anxiety. Based on the assessments, it is expected that the intervention group will present a reduction of 150kcal/day less than the control group at the end of follow-up.;To evaluate the 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.;To 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 LF/HF marker than the group that will consume a meal without ultra-processed foods.;To assess the subjective sensations of hunger, fullness, satisfaction and ability to eat, four questions were asked to the participants: 1) “How hungry are you now?” 2) “How full do you feel right now?” 3) “How much do you want to eat right now?” and 4) “How much do you think you can eat now?”. Individuals will be able to respond by pointing to a visual | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 and reactance data obtained in the evaluation are interpreted in the Body Composition RJL Systems software, thus defining the percentage of free mass of fat, fat and body water. Based on this, we believe that the intervention group at the end of the follow-up has 5% less body fat compared to the control group.;Evaluate the level of physical activity using estimation with the use of triaxial accelerometers (ActiGraph wGT3X-BT, ActiGraph LLC, Pensacola, Florida, United States), which monitor the physical activities performed by the individual on a daily basis, measuring acceleration in three body axes: anteroposterior, lateral and vertical. Thus, both groups are expected to show a reduction of up to 25% in the metabolic equivalent of the task.;Evaluate the profile of the intestinal microbiota of the participants through the sample of feces by the participant at home, with the aid of the PROBIOME collection kit after instructions given during the moment of inclusion of the participant. After delivering the samples, the collected microtubes will be submitted to the DNA extraction procedure metabacording and sequencing of amplicons of the 16S rRNA gene, V3-V4 region, according to the instructions of the specialized laboratory. From this, it is expected that the group that will be part of the group with restriction of ultra-processed foods will present a more diverse intestinal microbiota profile than the group that will not restrict ultra-processed foods. | — |
Countries
Brazil
Contacts
Public ContactNassib Bueno
Univerisidade Federal de Alagoas
Outcome results
None listed