Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD)

Obesity Clinical Trial

— Zelé2021  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06275347
• Other study ID #: 19CI 30 087 041
• Secondary ID: 1/1142021
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: May 25, 2023

Study information

• Verified date: February 2024
• Source: Universidad Veracruzana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 25, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 61 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Low-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.
• Hypocaloric Balanced Diet
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

Locations

Country	Name	City	State
Mexico	Francisco J Nachón García	Ciudad de Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Veracruzana

Country where clinical trial is conducted

Mexico, 

References & Publications (21)

Blackburn GL, Bistrian BR. Careers in nutrition from the clinical viewpoint. Nutr Rev. 1976 Apr;34(4):97-104. doi: 10.1111/j.1753-4887.1976.tb05719.x. No abstract available. — View Citation

Blackburn GL. Weight of the nation: moving forward, reversing the trend using medical care. Am J Clin Nutr. 2012 Nov;96(5):949-50. doi: 10.3945/ajcn.112.049643. Epub 2012 Oct 3. No abstract available. — View Citation

Cano-Rodríguez I, Ballesteros-Pomar MD, Pérez-Corral B, Aguado R. Dietas bajas en hidratos de carbono frente a dietas bajas en grasas. Endocrinol Nutr 2006;53(3):209-17 dol: http://dx.doi.org/10.1016/s1575-0922(06)71091-9

Colombo O, Ferretti VV, Ferraris C, Trentani C, Vinai P, Villani S, Tagliabue A. Is drop-out from obesity treatment a predictable and preventable event? Nutr J. 2014 Feb 3;13:13. doi: 10.1186/1475-2891-13-13. — View Citation

Díaz-Muñoz GA, Castañeda-Gómez ÁM, Belalcázar-Monsalve MP, Zambrano-Salazar JP, Bautista-Velandia MC, Ballesteros-Arbeláez F. Efecto de la dieta cetogénica baja en calorías sobre la composición corporal en adultos con sobrepeso y obesidad: revisión sistem

Elfhag K, Rossner S. Initial weight loss is the best predictor for success in obesity treatment and sociodemographic liabilities increase risk for drop-out. Patient Educ Couns. 2010 Jun;79(3):361-6. doi: 10.1016/j.pec.2010.02.006. Epub 2010 Mar 11. — View Citation

Foster D, Sanchez-Collins S, Cheskin LJ. Multidisciplinary Team-Based Obesity Treatment in Patients With Diabetes: Current Practices and the State of the Science. Diabetes Spectr. 2017 Nov;30(4):244-249. doi: 10.2337/ds17-0045. Erratum In: Diabetes Spectr. 2018 Feb;31(1):119. — View Citation

Goday A, Bellido D, Sajoux I, Crujeiras AB, Burguera B, Garcia-Luna PP, Oleaga A, Moreno B, Casanueva FF. Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patie — View Citation

Handjieva-Darlenska T, Handjiev S, Larsen TM, van Baak MA, Jebb S, Papadaki A, Pfeiffer AF, Martinez JA, Kunesova M, Holst C, Saris WH, Astrup A. Initial weight loss on an 800-kcal diet as a predictor of weight loss success after 8 weeks: the Diogenes stu — View Citation

Hemmingsson E, Johansson K, Eriksson J, Sundstrom J, Neovius M, Marcus C. Weight loss and dropout during a commercial weight-loss program including a very-low-calorie diet, a low-calorie diet, or restricted normal food: observational cohort study. Am J Clin Nutr. 2012 Nov;96(5):953-61. doi: 10.3945/ajcn.112.038265. Epub 2012 Sep 18. — View Citation

Joint WHO/FAO/UNU Expert Consultation. Protein and amino acid requirements in human nutrition. World Health Organ Tech Rep Ser. 2007;(935):1-265, back cover. — View Citation

Larsen TM, Dalskov SM, van Baak M, Jebb SA, Papadaki A, Pfeiffer AF, Martinez JA, Handjieva-Darlenska T, Kunesova M, Pihlsgard M, Stender S, Holst C, Saris WH, Astrup A; Diet, Obesity, and Genes (Diogenes) Project. Diets with high or low protein content a — View Citation

Lartey S, Si L, Lung T, Magnussen CG, Boateng GO, Minicuci N, Kowal P, Hayes A, de Graaff B, Blizzard L, Palmer AJ. Impact of overweight and obesity on life expectancy, quality-adjusted life years and lifetime costs in the adult population of Ghana. BMJ Glob Health. 2020 Sep;5(9):e003332. doi: 10.1136/bmjgh-2020-003332. — View Citation

Merra G, Gratteri S, De Lorenzo A, Barrucco S, Perrone MA, Avolio E, Bernardini S, Marchetti M, Di Renzo L. Effects of very-low-calorie diet on body composition, metabolic state, and genes expression: a randomized double-blind placebo-controlled trial. Eu — View Citation

Moreno B, Crujeiras AB, Bellido D, Sajoux I, Casanueva FF. Obesity treatment by very low-calorie-ketogenic diet at two years: reduction in visceral fat and on the burden of disease. Endocrine. 2016 Dec;54(3):681-690. doi: 10.1007/s12020-016-1050-2. Epub 2 — View Citation

Nackers LM, Ross KM, Perri MG. The association between rate of initial weight loss and long-term success in obesity treatment: does slow and steady win the race? Int J Behav Med. 2010 Sep;17(3):161-7. doi: 10.1007/s12529-010-9092-y. — View Citation

Palgi A, Read JL, Greenberg I, Hoefer MA, Bistrian BR, Blackburn GL. Multidisciplinary treatment of obesity with a protein-sparing modified fast: results in 668 outpatients. Am J Public Health. 1985 Oct;75(10):1190-4. doi: 10.2105/ajph.75.10.1190. — View Citation

Pirozzo S, Summerbell C, Cameron C, Glasziou P. Should we recommend low-fat diets for obesity? Obes Rev. 2003 May;4(2):83-90. doi: 10.1046/j.1467-789x.2003.00099.x. Erratum In: Obes Rev. 2003 Aug;4(3):185. — View Citation

Romano L, Marchetti M, Gualtieri P, Di Renzo L, Belcastro M, De Santis GL, Perrone MA, De Lorenzo A. Effects of a Personalized VLCKD on Body Composition and Resting Energy Expenditure in the Reversal of Diabetes to Prevent Complications. Nutrients. 2019 J — View Citation

Sajoux I, Lorenzo PM, Gomez-Arbelaez D, Zulet MA, Abete I, Castro AI, Baltar J, Portillo MP, Tinahones FJ, Martinez JA, Crujeiras AB, Casanueva FF. Effect of a Very-Low-Calorie Ketogenic Diet on Circulating Myokine Levels Compared with the Effect of Baria — View Citation

Tsai AG, Wadden TA. The evolution of very-low-calorie diets: an update and meta-analysis. Obesity (Silver Spring). 2006 Aug;14(8):1283-93. doi: 10.1038/oby.2006.146. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to this nutritional intervention	It will be measured by complied or did not comply with the program, making a question.	Every week for 4 months, then every month for a two years
Other	Satisfaction survey	Interrogation very satified to very dissatisfied	Every week for 4 months, then every month for a two years
Primary	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.	Every week for 4 months, then every month for two years
Primary	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	Every week for 4 months, then every month for two years
Primary	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	Every week for 4 months, then every month for two years
Primary	Visceral Fat	It will be measured with unit index, from 1 to 40, with a Multi-frequency Bioelectrical Impedance Equipment	Every week for 4 months, then every month for two years
Primary	Bone mass	the skeletal weight will be measured with unit kilograms (kg), from 1 to 70 kg, with a Multi-frequency Bioelectrical Impedance Equipment	Every week for 4 months, then every month for two years
Primary	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	Every week for 4 months, then every month for two years
Primary	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	Every week for 4 months, then every month for two years
Primary	Hip circumference	Circumference of the widest part above the buttocks. Unit cm, minimum 30, maximum 200. Measuring with tape measure	Every week for 4 months, then every month for two years
Primary	Muscular strenght	Isometric muscle strenght in the dominant hand, unit kilograms (kg)/ Strength, registration form digital dynamometer	Every week for 4 months, then every month for two years
Primary	Weight	it will be measured in unit kilograms, in a weighing machine	Every week for 4 months, then every month for two years
Primary	Height	The size will be measured in meters with a stadiometer	Every week for 4 months, then every month for two years
Primary	BMI Body index mass	Body mass index is an index composed of weight/height squared in kg/m2.	Every week for 4 months, then every month for two years
Secondary	Hemoglobin	It will be measured by a Clinical laboratory determination, unit gr/L (grams/liters)	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Hematocrit	It will be measured by a Clinical laboratory determination, unit percentage (%), minimumm 10, maximum 16	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Leukocytes	It will be measured by a Clinical laboratory determination, unit quantity per cc, minimumm 4000, maximum 18000.	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Fasting Blood Glucose	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.	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Glycated hemoglobin (HbA1c)	It will be measured by a blood tests, unit percentage (%), 6% very low, 7% moderate, 8% high, 9% very high, 10% risk.	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Insulin	It will be measured by a blood tests, unit UI/ml (Interantional unit/ mililiter), hyperinsulinemia >6UI/ml	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Creatinine	It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), minimum 0.4, maximum 1.3	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Urea	It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), minimum 8, maximum 54	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Uric acid	It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), minimum 2.4, maximum 9.	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Sodium	It will be measured by a blood tests, unit mEq/l (miliequivalents/ litre), minimum 90, maximum 110.	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Potassium	It will be measured by a blood tests, unit mEq/l (miliequivalents/ litre), minimum 3.5, maximum 5.5	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Calcium	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 8.5, maximum 10.5	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Phosphorus	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 2.5, maximum 4.5,	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Magnesium	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 1.5, maximum 2.5,	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Albumin	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 3.4, maximum 5.4,	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Direct bilirubin	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)	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Indirect bilirubin	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 0.1, maximum 0.5	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Total bilirubin	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 0.1, maximum 1.2	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Alanine aminotransferase	It will be measured by a blood tests, unit IU/L (interantional unit/ liters), minimum 10, maximum 41.	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Aspartate Amino Transferase	It will be measured by a blood tests, unit IU/L (interantional unit/ liters), minimum 5, maximum 37	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Total cholesterol	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 100, maximum 200	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Triglycerides	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 100, maximum 500	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	High Density Lipoproteins	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), greater than 40 mg/dl	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Low Density lipoproteins	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), less than 100 mg/dl	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Protein C Reactive	It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), less than 10 mg/dl	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Thyroid stimulating hormone	It will be measured by a blood tests, unit IU/L (interantional unit/ liters), from 0.3 to 3 IU	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Triiodothyronine	It will be measured by a blood tests, unit IU/L (nanograms/ mililiters), from 0.8 to 2 ng/ml	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Thyroxine	It will be measured by a blood tests, unit pg/ml (picograms/ mililiters), from 5.4 to 11.5 pg/ml	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Cholecalciferol	It will be measured by a blood tests, unit ng/ml (nanograms/ mililiters), from 25 to 90 ng/ml	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Gasometric variables, Partial pressure of oxygen (PaO2)	It will be measured by a blood tests, unit mmHg (milimeters of mercury), minimum 75, maximum 100	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	HCO3 (Bicarbonate ion plasma concentration)	It will be measured by a blood tests, unit mEq/L (miliequivalents per litre), minimum 21, maximum 30	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Arterial pH	It will be measured by a blood tests, minimum 7.35, maximum 7.45	Every 2 months for the first 6 months, then every 6 months for two years
Secondary	Lactic acid	It will be measured by a blood tests, unit mg/L (miligrams/liters), from 4.5 to 19 mg/L	Every 2 months for the first 6 months, then every 6 months for two years

External Links

•   Careers in nutrition from the clinical viewpoint.
•   Clinical correlates of weight loss and attrition during a 10-week dietary intervention study: results from the NUGENOB project.
•   Dietas bajas en hidratos de carbono frente a dietas bajas en grasas.
•   Efecto de la dieta cetogénica baja en calorías sobre la composición corporal en adultos con sobrepeso y obesidad: revisión sistemática y metaanálisis
•   Initial weight loss is the best predictor for success in obesity treatment and sociodemographic liabilities increase risk for drop-out
•   Initial weight loss on an 800-kcal diet as a predictor of weight loss success after 8 weeks: the Diogenes study.
•   Multidisciplinary team-based obesity treatment in patients with diabetes: Current practices and the state of the science.
•   Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus.
•   The association between rate of initial weight loss and long-term success in obesity treatment: Does slow and steady win the race?
•   Weight of the nation: moving forward, reversing the trend using medical care