Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD)

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Low-fat normoprotein Controlled Ketogenic Diet.; Other: Hypocaloric Balanced Diet

• Registration Number: NCT06275347
• Lead Sponsor: Universidad Veracruzana

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.

Study Timeline

• Study Start: 2021-01-15
• Primary Completion: 2021-12-30
• Study Completion: 2023-05-25
• Study First Submitted: 2023-12-08
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Very low calorie ketogenic low-fat diet (VLCKLFD)	Low-fat normoprotein Controlled Ketogenic Diet.	Frank ketosis: between 650 and 730 kcal/day in 5 mealtimes. This stage in the nutritional intervention was done during the first 4 weeks. Mixed Ketosis: in this stage, one intake of commercial preparations was replaced by proteins, which discreetly increased by 100 to 150 Kcal/day. This stage was done during the next 4 weeks.
Low-Calorie Diet (LCD)	Hypocaloric Balanced Diet	The usual caloric intake of a balanced LCD is between 1,200 and 1,500 kcal per day with a macronutrient distribution of 50% carbohydrates, 25% proteins and 25% fats, according to the Diogenes study

Primary Outcome Measures

Name	Time	Method
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
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
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
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.
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
Height	Every week for 4 months, then every month for two years	The size will be measured in meters with a stadiometer
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
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
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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
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
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,
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
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
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
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
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.
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
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
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)
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
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
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)
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.
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,
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
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
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
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
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.
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
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
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.
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
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
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

Trial Locations

Locations (1)

Francisco J Nachón García; 🇲🇽 Ciudad de Mexico, Mexico