Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD)

NCT06275347 | Completed DMC

• 2 other identifiers: 19CI 30 087 0411/1142021
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Weight

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

  Every week for 4 months, then every month for two years

• Height

  The size will be measured in meters with a stadiometer

  Every week for 4 months, then every month for two years

• 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 Outcomes (33)

• Hemoglobin

  Every 2 months for the first 6 months, then every 6 months for two years

• Hematocrit

  Every 2 months for the first 6 months, then every 6 months for two years

• Leukocytes

  Every 2 months for the first 6 months, then every 6 months for two years

• Fasting Blood Glucose

  Every 2 months for the first 6 months, then every 6 months for two years

• Glycated hemoglobin (HbA1c)

  Every 2 months for the first 6 months, then every 6 months for two years

Other Outcomes (2)

• Adherence to this nutritional intervention

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

• Satisfaction survey

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

Study Arms (2)

Intervention Very low calorie ketogenic low-fat diet (VLCKLFD)

EXPERIMENTAL

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.

Other: Low-fat normoprotein Controlled Ketogenic Diet.

Low-Calorie Diet (LCD)

ACTIVE COMPARATOR

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

Other: Hypocaloric Balanced Diet

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.

Also known as: Zelé

Intervention Very low calorie ketogenic low-fat diet (VLCKLFD)

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

Also known as: Low-Calorie Diet (CD)

Low-Calorie Diet (LCD)

Eligibility Criteria

• Age: 18 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Veracruzana: lead

Study Sites (1)

Francisco J Nachón García

Mexico City, Mexico

Location

Related Publications (21)

• 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.

  PMID: 4037162 BACKGROUND

• 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.

  PMID: 22990030 BACKGROUND

• 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.

  PMID: 32994229 BACKGROUND

• 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.

  PMID: 29151714 BACKGROUND

• 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.

  PMID: 12760443 RESULT

• 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.

  PMID: 817237 RESULT

• 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.

  PMID: 16988070 RESULT

• 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 patients with type 2 diabetes mellitus. Nutr Diabetes. 2016 Sep 19;6(9):e230. doi: 10.1038/nutd.2016.36.

  PMID: 27643725 RESULT

• 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.

  PMID: 20223613 RESULT

• 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 study. Eur J Clin Nutr. 2010 Sep;64(9):994-9. doi: 10.1038/ejcn.2010.110. Epub 2010 Jun 30.

  PMID: 20588292 RESULT

• 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.

  PMID: 20443094 RESULT

• 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.

  PMID: 23034956 RESULT

• 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 and glycemic index for weight-loss maintenance. N Engl J Med. 2010 Nov 25;363(22):2102-13. doi: 10.1056/NEJMoa1007137.

  PMID: 21105792 RESULT

• 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

  RESULT

• 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.

  PMID: 18330140 RESULT

• 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 sistemática y metaanálisis. Rev Nutr Clin Metab. 2021;4(3):98-113. http://dx.doi.org/10.35454/rncm.v4n3.273

  RESULT

• 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. Eur Rev Med Pharmacol Sci. 2017 Jan;21(2):329-345.

  PMID: 28165552 RESULT

• 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 Jul 4;11(7):1526. doi: 10.3390/nu11071526.

  PMID: 31277506 RESULT

• 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.

  PMID: 24490952 RESULT

• 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 2016 Sep 13.

  PMID: 27623967 RESULT

• 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 Bariatric Surgery or a Low-Calorie Diet in Patients with Obesity. Nutrients. 2019 Oct 4;11(10):2368. doi: 10.3390/nu11102368.

  PMID: 31590286 RESULT

Related Links

• 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.
• 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.
• 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
• 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

MeSH Terms

Conditions

Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD Senior Researcher of the Institute of Health Sciences at Universidad Veracruzana Xalapa

Model Details: A Randomized Clinical Trial was conducted in patients with obesity type I patients

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: February 23, 2024
• Study Start: January 15, 2021
• Primary Completion: December 30, 2021
• Study Completion: May 25, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)