Effects of dietary restriction of ultra-processed foods on the health of individuals with excess weight

INTERVENTION: E02.642.249.200 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 one of the secretaries of the Faculty of Nutrition not related to the research, to ensure allocation secrecy. Two interventions will be compared: a) One consisting of a diet with specific calorie restriction in ultra‐processed foods (CR‐UPF) (= 5% of energy intake from UPF) and b) another consisting of a diet with generic calorie restriction (CR‐G). The determination of the energy content of the diets will be done individually, that is, each participant will have their daily energy needs estimated with the aid of an indirect calorimeter and triaxial accelerometers and a caloric deficit calculated by the Body Weight Planner will be assigned, based on a standard 10% weight loss for 180 days. All diets will follow the distribution of macronutrients as recommended by the Associação Brasileira para o Estudo da Obesidade e Síndrome Metabólica. Thus, the only difference between the groups will be observed in the reduction of UPF consumption in the diets. After 180 days of weight loss, individuals will receive diets to maintain the lost weight, based on the measurement of energy needs measured in the sixth month of follow‐up until the 12th month. Follow‐ups will be carried out every 15 days during the first two months after delivery of the diets. In these first follow‐ups, food and nutrition education activities will be carried out on portioning and labeling, in addition to monitoring weight loss and main doubts. Those individuals who are allocated to the CR‐UPF group will have explanations directed to the NOVA classification of foods (in natura/minimally processed, processed CONDITION: C18.654 Obesity PRIMARY OUTCOME: 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. SECONDARY OUTCOME: Assess food addiction using the modified Yale Food Addiction Scale 2.0 (mYFAS 2.0). Based on this, it is expected that both groups will have a prevalence of food addiction of 18% at the end of follow‐up. Evaluate HDL‐cholesterol using blood samples taken in the morning, after fasting for 12 hours, blood samples will be collected by peripheral venipuncture in the left or right cubital fossa, taking 20 mL of blood, on average, and transferred to a gel tube separator. The collection will take place on the premises of the Faculty of Nutrition and the laboratory will only send the necessary professionals to carry out the collection and transport of the samples to the said laboratory. This measurement will occur before and after 6 months of intervention. From this, it is expected that the intervention group will show an increase of 5 mg/dL compared to the control group after the end of follow‐up. Evaluate LDL‐cholesterol through blood collections, after fasting for 12 hours, blood samples will be collected by peripheral venipuncture in the left or right cubital fossa, taking 20 mL of blood, on average, and transferred to a separator gel tube . The collection will take place on the premises of the Faculty of Nutrition and the laboratory will only send the necessary professionals to carry out the collection and transport of the samples to the said laboratory. This measurement will occur before and after 6 months of intervention. The intervention group is expected to show a reduction of 15 mg/dL more than the control group at the end of follow‐up. 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. Evaluate postprandial Ghrelin using hormone analysis, which will be performed using the Human Metabolic Hormone Magnetic Bead Panel ‐ Metabolism Multiple XAssay (HMHEMAK‐4K, MERCK KGAA, Darmstadt, Germany). This measurement will be performed 90 minutes after the test meal. Based on this assessment, it is expected that the group that will have a meal with ultra‐processed foods will present a 10% lower reduction than the group that will consume a meal without ultra‐processed foods. Evaluate postprandial glucagon‐like peptide 1 (GLP‐1) using hormone analysis, which will be performed using the Human Metabolic Hormone Magnetic Bead Panel ‐ Metabolism Multiple XAssay (HMHEMAK‐4K, MERCK KGAA, Darmstadt, Germany). This measurement will be performed 90 minutes after the test meal. From this, it is expected that the group that will eat ultra‐processed foods will show a 10% greater increase than the group that will consume meals without ultra‐processed foods. Evaluate proprandial Leptin using hormonal analysis, which will be performed using the Human Metabolic Hormone Magnetic Bead Panel ‐ Metabolism Multiple XAssay (HMHEMAK‐4K, MERCK KGAA, Darmstadt, Germany). This measurement will be performed 90 minutes after the test meal. From this, it is expected that the group that will eat ultra‐processed foods will show a 10% lower increase than the group that will consume meals without ultra‐processed foods. Evaluate 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. 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 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. Evaluate the postprandial glycemia after 90 minutes of the participants' test meal. From this assessment, it is expected that the group that will consume the meal of only ultra‐processed foods will present an average of postprandial glycemia of 130 mg/dL, while the group that will consume the meal of in natura and minimally processed foods, a glycemia postprandial dose of 120 mg/dL. Evaluate the postprandial insulin after 90 minutes of the test meal of the participants who will have the blood drawn. From this, it is expected that the group that will consume the meal without ultra‐processed foods will present a postprandial insulin 15% lower than the group that will receive the meal with only ultra‐processed foods. In addition, it is expected that the group that will have a meal with ultra‐processed foods will show a 10% greater increase than the group that will consume a meal without ultra‐processed foods. Evaluate the postprandial PYY using the hormone analysis method, which will be done using the Human Metabolic Hormone Magnetic Bead Panel ‐ Metabolism Multiple XAssay (HMHEMAK‐4K, MERCK KGAA, Darmstadt, Germany). This measurement will be performed 90 minutes after the test meal. From this, it is expected that the group that will eat ultra‐processed foods will show a 10% lower increase than the group that will consume meals without ultra‐processed foods. Evaluate Thyroxine (T4) through blood collections that will be performed in the morning, after fasting for 12 hours, blood samples will be collected by peripheral venipuncture in the left or right cubital fossa, removing 20 mL of blood, on average, and transferred to separator gel tube. The collection will take place on the premises of the Faculty of Nutrition and the laboratory will only send the necessary professionals to carry out the collection and transport of the samples to the said laboratory. Based on the analyses, it is expected that there will be no difference between the groups at the end of the follow‐up. In order to evaluate the time of the test meal, the time in which the individual manages to consume the entire delivered test meal will be timed, making it possible to calculate the indices grams consumed/minute and calories consumed/minute. From this, it is expected that the group that eats the ultra‐processed food meal will consume everything 5 minutes faster than the group that will eat in natura and minimally processed foods. 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. 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. The evaluation of postprandial gastric inhibitory peptide (GIP) will be using hormone analysis, which will be done using the Human Metabolic Hormone Magnetic Bead Panel ‐ Metabolism Multiple XAssay (HMHEMAK‐4K, MERCK KGAA, Darmstadt, Germany). This measurement will be performed 90 minutes after the test meal. In view of this, it is expected that the group that will eat ultra‐processed foods will show a 10% lower increase than the group that will consume meals without ultra‐processed foods. The evaluation of Thyroid Stimulating Hormone (TSH) will have blood samples taken in the morning, after fasting for 12 hours. Blood samples will be collected by peripheral venipuncture in the left or right cubital fossa, taking 20 mL of blood, on average, and transferred to a separator gel tube. The collection will take place on the premises of the Faculty of Nutrition and the laboratory will only send the necessary professionals to carry out the collection and transport of the samples to the said laboratory. From this, it is expected that there will be no difference between the groups at the end of the follow‐up. 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 analogue scale (VAS) ranging from 0 to 10, in which the number 0 corresponds to “not at all/none” and 10 to “a lot”. These questions will be asked at the same moment before the collection of resting energy expenditure and body composition, with participants fasting for 12 hours, immediately after the test meal, and after 75‐90 minutes of the test meal. Still using the VAS, the participants will be asked how pleasant and familiar the test meal was immediately after consuming the food. The intervention group is expected to be 25% more hungry and able to eat, and 25% less full, than the control group at the end of follow‐up. While the control group will present 25% more satisfaction than the intervention group. To evaluate Tri‐iodothyronine (T3) blood collections will be performed in the morning, after fasting for 12 hours, blood samples will be collected by peripheral venipuncture in the left or right cubital fossa, removing 20 mL of blood, on average, and transferred for separator gel tube. The collection will take place on the premises of the Faculty of Nutrition and the laboratory will only send the necessary professionals to carry out the collection and transport of the samples to the said laboratory. From this, it is expected that there will be no difference between the groups at the end of the follow‐up. 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 inde Xbetween 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