Clinical trial NCT06275347: Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD)
Official title: Comparative Study of the Response to Weight Loss and Metabolic Conditions Using Two Non-pharmacological Nutritional Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Universidad Veracruzana
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Clinical Trial was conducted in patients with obesity type I patients
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the efficacy of this nutritional intervention
timeFrame: Every week for 4 months, then every month for two years
measure: Volume of total body tissue corresponding to muscle
timeFrame: Every week for 4 months, then every month for two years
measure: Percentage of body weight made up of adipose tissue
timeFrame: Every week for 4 months, then every month for two years
measure: Visceral Fat
timeFrame: Every week for 4 months, then every month for two years
measure: Bone mass
timeFrame: Every week for 4 months, then every month for two years
measure: Total body water
timeFrame: Every week for 4 months, then every month for two years
measure: Waist circumference
timeFrame: Every week for 4 months, then every month for two years
measure: Hip circumference
timeFrame: Every week for 4 months, then every month for two years
measure: Muscular strenght
timeFrame: Every week for 4 months, then every month for two years
measure: Weight
timeFrame: Every week for 4 months, then every month for two years
measure: Height
timeFrame: Every week for 4 months, then every month for two years
measure: BMI Body index mass
timeFrame: Every week for 4 months, then every month for two years
Secondary outcomes:
measure: Hemoglobin
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Hematocrit
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Leukocytes
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Fasting Blood Glucose
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Glycated hemoglobin (HbA1c)
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Insulin
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Creatinine
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Urea
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Uric acid
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Sodium
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Potassium
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Calcium
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Phosphorus
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Magnesium
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Albumin
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Direct bilirubin
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Indirect bilirubin
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Total bilirubin
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Alanine aminotransferase
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Aspartate Amino Transferase
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Total cholesterol
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Triglycerides
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: High Density Lipoproteins
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Low Density lipoproteins
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Protein C Reactive
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Thyroid stimulating hormone
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Triiodothyronine
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Thyroxine
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Cholecalciferol
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Gasometric variables, Partial pressure of oxygen (PaO2)
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: HCO3 (Bicarbonate ion plasma concentration)
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Arterial pH
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
measure: Lactic acid
timeFrame: Every 2 months for the first 6 months, then every 6 months for two years
Other outcomes:
measure: Adherence to this nutritional intervention
timeFrame: Every week for 4 months, then every month for a two years
measure: Satisfaction survey
timeFrame: Every week for 4 months, then every month for a two years
Locations:
city: Ciudad de Mexico
country: Mexico
facility: Francisco J Nachón García
Study officials:
References:
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.
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.
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.
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.
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.
citation: 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.
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.
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 patients with type 2 diabetes mellitus. Nutr Diabetes. 2016 Sep 19;6(9):e230. doi: 10.1038/nutd.2016.36.
citation: 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.
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 study. Eur J Clin Nutr. 2010 Sep;64(9):994-9. doi: 10.1038/ejcn.2010.110. Epub 2010 Jun 30.
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.
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.
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 and glycemic index for weight-loss maintenance. N Engl J Med. 2010 Nov 25;363(22):2102-13. doi: 10.1056/NEJMoa1007137.
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
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.
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 sistemática y metaanálisis. Rev Nutr Clin Metab. 2021;4(3):98-113. http://dx.doi.org/10.35454/rncm.v4n3.273
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. Eur Rev Med Pharmacol Sci. 2017 Jan;21(2):329-345.
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 Jul 4;11(7):1526. doi: 10.3390/nu11071526.
citation: 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.
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 2016 Sep 13.
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 Bariatric Surgery or a Low-Calorie Diet in Patients with Obesity. Nutrients. 2019 Oct 4;11(10):2368. doi: 10.3390/nu11102368.