Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD)

Universidad Veracruzana88 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity

Interventions

Low-fat normoprotein Controlled Ketogenic Diet.OTHER

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.

Hypocaloric Balanced DietOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 61 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Francisco J Nachón García

Mexico City, Mexico

Outcomes

Primary Outcomes

Evaluate the efficacy of this nutritional intervention

The primary outcome measure was body weight operationalized as the change in an individual's mass or weight loss in kilograms.

Time frame: Every week for 4 months, then every month for two years

Volume of total body tissue corresponding to muscle

It will be measured with unit Kilogram, minimun 10, maximum 150, with a Multi-frequency Bioelectrical Impedance Equipment

Time frame: Every week for 4 months, then every month for two years

Percentage of body weight made up of adipose tissue

It will be measured with unit percentaje, minimum 9, maximum 90, with a Multi-frequency Bioelectrical Impedance Equipment

Time frame: Every week for 4 months, then every month for two years

Visceral Fat

It will be measured with unit index, from 1 to 40, with a Multi-frequency Bioelectrical Impedance Equipment

Time frame: Every week for 4 months, then every month for two years

Bone mass

the skeletal weight will be measured with unit kilograms (kg), from 1 to 70 kg, with a Multi-frequency Bioelectrical Impedance Equipment

Time frame: Every week for 4 months, then every month for two years

Total body water

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

Time frame: Every week for 4 months, then every month for two years

Waist circumference

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

Data from ClinicalTrials.gov

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