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Completed

NCT Number: NCT06275347

Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD)

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–61 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Francisco J Nachón García

Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Zelé

hypocaloric balanced diet

Other

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

Other names: Low-Calorie Diet (CD)

Primary outcomes

  1. Evaluate the efficacy of this nutritional intervention

    Time frame: 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.

  2. Volume of total body tissue corresponding to muscle

    Time frame: 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

  3. Percentage of body weight made up of adipose tissue

    Time frame: 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

  4. Visceral Fat

    Time frame: 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

  5. Bone mass

    Time frame: 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

  6. Total body water

    Time frame: 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

  7. Waist circumference

    Time frame: 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

  8. Hip circumference

    Time frame: 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

  9. Muscular strenght

    Time frame: 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

  10. Weight

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

    it will be measured in unit kilograms, in a weighing machine

  11. Height

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

    The size will be measured in meters with a stadiometer

  12. BMI Body index mass

    Time frame: 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 outcomes

  1. Hemoglobin

    Time frame: 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)

  2. Hematocrit

    Time frame: 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

  3. Leukocytes

    Time frame: 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.

  4. Fasting Blood Glucose

    Time frame: 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.

  5. Glycated hemoglobin (HbA1c)

    Time frame: 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.

  6. Insulin

    Time frame: 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

  7. Creatinine

    Time frame: 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

  8. Urea

    Time frame: 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

  9. Uric acid

    Time frame: 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.

  10. Sodium

    Time frame: 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.

  11. Potassium

    Time frame: 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

  12. Calcium

    Time frame: 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

  13. Phosphorus

    Time frame: 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,

  14. Magnesium

    Time frame: 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,

  15. Albumin

    Time frame: 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,

  16. Direct bilirubin

    Time frame: 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)

  17. Indirect bilirubin

    Time frame: 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

  18. Total bilirubin

    Time frame: 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

  19. Alanine aminotransferase

    Time frame: 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.

  20. Aspartate Amino Transferase

    Time frame: 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

  21. Total cholesterol

    Time frame: 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

  22. Triglycerides

    Time frame: 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

  23. High Density Lipoproteins

    Time frame: 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

  24. Low Density lipoproteins

    Time frame: 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

  25. Protein C Reactive

    Time frame: 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

  26. Thyroid stimulating hormone

    Time frame: 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

  27. Triiodothyronine

    Time frame: 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

  28. Thyroxine

    Time frame: 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

  29. Cholecalciferol

    Time frame: 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

  30. Gasometric variables, Partial pressure of oxygen (PaO2)

    Time frame: 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

  31. HCO3 (Bicarbonate ion plasma concentration)

    Time frame: 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

  32. Arterial pH

    Time frame: 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

  33. Lactic acid

    Time frame: 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

Other outcomes

  1. Adherence to this nutritional intervention

    Time frame: 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.

  2. Satisfaction survey

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

    Interrogation very satified to very dissatisfied

Sponsors and collaborators

Lead sponsor

Universidad Veracruzana

Other

Registry information

Official study title

Comparative Study of the Response to Weight Loss and Metabolic Conditions Using Two Non-pharmacological Nutritional Programs

Acronym: Zelé2021

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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