Obesity
Conditions
Brief summary
This study aimed to assess the efficacy and safety of the Zélé program, a controlled ketogenic diet, for weight loss and maintenance. It involved a randomized clinical trial with participants aged 18-60, BMI between 30-34.9 kg/m², and no severe health issues
Detailed description
The study will be conducted in Mexico City under the sponsorship of Zélé® and in collaboration with the VIME Weight Loss and Wellness Center of Mexico. During the year 2021 and with follow-up for 24 months. An open call will be made through different media including social networks for the recruitment of patients who meet the inclusion criteria and must present themselves for a clinical evaluation in which pathological history, clinical status, heart rate, blood pressure, oxygenation and temperature will be recorded. Nutritional assessment, and a Complete Blood Count, a biochemical profile. Patients who meet all the inclusion criteria will be selected and will have an interview with the principal investigator in which they will sign their letter of commitment and informed consent, then they will be subjected to the randomization process with a 2:1 allocation for treatment and controls, respectively. Subsequently, they will be submitted to the two nutritional treatments and will be clinically evaluated every week and will receive nutritional, psycho emotional and physical activity counseling. At each visit, adverse effects, changes in clinical status will be recorded and the presence of ketone bodies in capillary blood will be determined. Subsequently, only clinical and nutritional follow-up will be given along with psycho-emotional support and physical activity advice every 3 months up to 12 months and every 6 months up to 24 months.
Interventions
OTHERLow-fat normoprotein Controlled Ketogenic Diet.
Frank ketosis will consist of between 650 and 730 kcal/day in 5 meal times, based on commercial and vegetable preparations with low glycemic index, an average of 1.2 g of protein/kg of ideal weight/day, 20 g/day of lipids based on essential fatty acids and less than 60 g/day of absorbable carbohydrates. Patients will receive vitamin and sodium chloride, magnesium oxide, calcium carbonate. Mixed Ketosis one or two intakes of commercial preparations will be progressively replaced by proteins, which will increase by 100 to 150 Kcal/day, supplementation of vitamins and minerals will continue. Transition Stage simple carbohydrates and some complex carbohydrates are added to the previous program, in an approximate proportion of 30 to 35% protein, 25% fat and 40 to 45 % carbohydrates. Integral and maintenance phase: may vary between 1300 and 2250 kcal/day, with a macronutrient distribution of 50% carbohydrates, 25% proteins and 25% fats.
Balanced hypocaloric diet (caloric intake 20% below basal metabolic expenditure measured by Multifrequency Bioelectrical Impedance or calculated according to the FAO/WHO/UN formula (FAO/WHO/UNU (1985). Energy and Protein requirements. Technical Report Series No 724, World Health Organization, Geneva). The usual caloric intake of a balanced hypocaloric diet is between 1,200 and 1,400 kcal per day with a macronutrient distribution of 50% carbohydrates, 25% proteins and 25% fats, according to the Diogenes study
Sponsors
Universidad Veracruzana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Eligible patients were assigned to a one of the four VIME Weight Loss and Wellness Center for management and follow up according to their preference, a sequential number in inclusion order was given, with all the patients coded with a 4-digit number. This code was sent to the people in the food production plant where the patients were randomized in a double blinded study, with a 2:1 allocation for low-fat, normo-protein, controlled ketogenic diet (Zélé method) or low calories diet
Intervention model description
A Randomized Clinical Trial was conducted in patients with obesity type I patients
Eligibility
Sex/Gender
ALL
Age
18 Years to 61 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients of either sex, between 18 and 60 years old, with a body mass index (BMI) between 30 and 34.9 kg/m2 were eligible to participate in the study. We recruited participants from Mexico City through different media including social networks (Facebook and Instagram). The selection was consecutive according to the order of response of the interested participants. All participants read and signed the Informed Consent form
Exclusion criteria
* Pregnant or breastfeeding patients, patients with severe eating disorders, alcoholism, or drug addiction, patients with severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, mayor depression), patients with hepatic alteration defined as increase of ALT, AST, GGT more than 4 folds the reference value, patients with renal impairment defined as a glomerular filtration rate below 60 ml/min. Patients with type 1 or insulin-dependent DM, or DM2 on insulin therapy, patients with obesity caused by endocrinological diseases (except type 2 DM), patients with hemopathies, cancer patients, patients with active cardiovascular or cerebrovascular disease (heart rhythm disorders, recent infarction \[\<6m\], unstable angina, decompensated heart failure, recent vascular accident \[\<6m\]), patients with gout, patients with known renal lithiasis or cholelithiasis, patients with electrolyte disorders, patients with orthostatic hypotension, patients with known an altered or abnormal electrocardiogram.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI Body index mass | Every week for 4 months, then every month for two years | Body mass index is an index composed of weight/height squared in kg/m2. |
| Height | Every week for 4 months, then every month for two years | The size will be measured in meters with a stadiometer |
| Evaluate the efficacy of this nutritional intervention | Every week for 4 months, then every month for two years | The primary outcome measure was body weight operationalized as the change in an individual's mass or weight loss in kilograms. |
| Volume of total body tissue corresponding to muscle | Every week for 4 months, then every month for two years | It will be measured with unit Kilogram, minimun 10, maximum 150, with a Multi-frequency Bioelectrical Impedance Equipment |
| Percentage of body weight made up of adipose tissue | Every week for 4 months, then every month for two years | It will be measured with unit percentaje, minimum 9, maximum 90, with a Multi-frequency Bioelectrical Impedance Equipment |
| Visceral Fat | Every week for 4 months, then every month for two years | It will be measured with unit index, from 1 to 40, with a Multi-frequency Bioelectrical Impedance Equipment |
| Bone mass | Every week for 4 months, then every month for two years | the skeletal weight will be measured with unit kilograms (kg), from 1 to 70 kg, with a Multi-frequency Bioelectrical Impedance Equipment |
| Total body water | Every week for 4 months, then every month for two years | Percentage of the body that corresponds to water, unit % (percentaje) and/ or kilograms (kg) from 0 to 150 with a Multi-frequency bioelectrical impedance equipment |
| Waist circumference | Every week for 4 months, then every month for two years | Measurement made with a tape measure directly on the skin (without clothing). It will be measured at the height of the middle of the armpit, at the point between the bottom of the last rib and the highest part of the hip. Unit centimeters (cm), minimum 30, maximum 200, Using tape measure |
| Hip circumference | Every week for 4 months, then every month for two years | Circumference of the widest part above the buttocks. Unit cm, minimum 30, maximum 200. Measuring with tape measure |
| Muscular strenght | Every week for 4 months, then every month for two years | Isometric muscle strenght in the dominant hand, unit kilograms (kg)/ Strength, registration form digital dynamometer |
| Weight | Every week for 4 months, then every month for two years | it will be measured in unit kilograms, in a weighing machine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calcium | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 8.5, maximum 10.5 |
| Phosphorus | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 2.5, maximum 4.5, |
| Magnesium | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 1.5, maximum 2.5, |
| Albumin | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 3.4, maximum 5.4, |
| Direct bilirubin | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), normal value less than 0.3 mg/dl (0 less than 5.1mg/dl) |
| Indirect bilirubin | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 0.1, maximum 0.5 |
| Total bilirubin | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 0.1, maximum 1.2 |
| Alanine aminotransferase | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit IU/L (interantional unit/ liters), minimum 10, maximum 41. |
| Aspartate Amino Transferase | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit IU/L (interantional unit/ liters), minimum 5, maximum 37 |
| Total cholesterol | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 100, maximum 200 |
| Triglycerides | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 100, maximum 500 |
| High Density Lipoproteins | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), greater than 40 mg/dl |
| Low Density lipoproteins | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), less than 100 mg/dl |
| Protein C Reactive | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), less than 10 mg/dl |
| Thyroid stimulating hormone | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit IU/L (interantional unit/ liters), from 0.3 to 3 IU |
| Thyroxine | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit pg/ml (picograms/ mililiters), from 5.4 to 11.5 pg/ml |
| Cholecalciferol | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit ng/ml (nanograms/ mililiters), from 25 to 90 ng/ml |
| Gasometric variables, Partial pressure of oxygen (PaO2) | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mmHg (milimeters of mercury), minimum 75, maximum 100 |
| HCO3 (Bicarbonate ion plasma concentration) | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mEq/L (miliequivalents per litre), minimum 21, maximum 30 |
| Arterial pH | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, minimum 7.35, maximum 7.45 |
| Lactic acid | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/L (miligrams/liters), from 4.5 to 19 mg/L |
| Triiodothyronine | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit IU/L (nanograms/ mililiters), from 0.8 to 2 ng/ml |
| Hemoglobin | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a Clinical laboratory determination, unit gr/L (grams/liters) |
| Hematocrit | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a Clinical laboratory determination, unit percentage (%), minimumm 10, maximum 16 |
| Leukocytes | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a Clinical laboratory determination, unit quantity per cc, minimumm 4000, maximum 18000. |
| Fasting Blood Glucose | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), Normoglycemia in fasting 70 to 100 mg/dl. Hyperglycemia higher than 100 mg/dl in fasting. Diabetes 126 mg/Dl of fasting blood glucose. |
| Glycated hemoglobin (HbA1c) | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit percentage (%), 6% very low, 7% moderate, 8% high, 9% very high, 10% risk. |
| Insulin | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit UI/ml (Interantional unit/ mililiter), hyperinsulinemia \>6UI/ml |
| Creatinine | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), minimum 0.4, maximum 1.3 |
| Urea | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), minimum 8, maximum 54 |
| Uric acid | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), minimum 2.4, maximum 9. |
| Sodium | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mEq/l (miliequivalents/ litre), minimum 90, maximum 110. |
| Potassium | Every 2 months for the first 6 months, then every 6 months for two years | It will be measured by a blood tests, unit mEq/l (miliequivalents/ litre), minimum 3.5, maximum 5.5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence to this nutritional intervention | Every week for 4 months, then every month for a two years | It will be measured by complied or did not comply with the program, making a question. |
| Satisfaction survey | Every week for 4 months, then every month for a two years | Interrogation very satified to very dissatisfied |
Countries
Mexico
Outcome results
None listed