ObesityZelé2021NCT06275347
Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD)
A study testing Hypocaloric Balanced Diet in people with Obesity, run by Universidad Veracruzana at 1 site in Mexico.
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 Read more about this study
- Who is it for?
- Ages 18 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Hypocaloric Balanced Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jan 2021to 25 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Response to Weight Loss and Metabolic Conditions Using Two Non-pharmacological Nutritional Programs
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
Read the 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.
- Conditions
- Obesity
- Being tested
- Low-fat normoprotein Controlled Ketogenic Diet., Hypocaloric Balanced Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat normoprotein Controlled Ketogenic Diet.Other
Also called Zelé
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 DietOther
Also called Low-Calorie Diet (CD)
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Hypocaloric Balanced Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Every week for 4 months, then every month for two years
Weight
it will be measured in unit kilograms, in a weighing machine
Measured: Every week for 4 months, then every month for two years
Height
The size will be measured in meters with a stadiometer
Measured: 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.
Measured: Every week for 4 months, then every month for two years
Secondary outcomes (33)
Hemoglobin
It will be measured by a Clinical laboratory determination, unit gr/L (grams/liters)
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Hematocrit
It will be measured by a Clinical laboratory determination, unit percentage (%), minimumm 10, maximum 16
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Leukocytes
It will be measured by a Clinical laboratory determination, unit quantity per cc, minimumm 4000, maximum 18000.
Measured: Every 2 months for the first 6 months, then every 6 months for two years
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.
Measured: Every 2 months for the first 6 months, then every 6 months for two years
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.
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Insulin
It will be measured by a blood tests, unit UI/ml (Interantional unit/ mililiter), hyperinsulinemia >6UI/ml
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Creatinine
It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), minimum 0.4, maximum 1.3
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Urea
It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), minimum 8, maximum 54
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Uric acid
It will be measured by a blood tests, unit mg/dl (miligrams/deciliters), minimum 2.4, maximum 9.
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Sodium
It will be measured by a blood tests, unit mEq/l (miliequivalents/ litre), minimum 90, maximum 110.
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Potassium
It will be measured by a blood tests, unit mEq/l (miliequivalents/ litre), minimum 3.5, maximum 5.5
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Calcium
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 8.5, maximum 10.5
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Phosphorus
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 2.5, maximum 4.5,
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Magnesium
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 1.5, maximum 2.5,
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Albumin
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 3.4, maximum 5.4,
Measured: Every 2 months for the first 6 months, then every 6 months for two years
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)
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Indirect bilirubin
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 0.1, maximum 0.5
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Total bilirubin
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 0.1, maximum 1.2
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Alanine aminotransferase
It will be measured by a blood tests, unit IU/L (interantional unit/ liters), minimum 10, maximum 41.
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Aspartate Amino Transferase
It will be measured by a blood tests, unit IU/L (interantional unit/ liters), minimum 5, maximum 37
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Total cholesterol
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 100, maximum 200
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Triglycerides
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), minimum 100, maximum 500
Measured: Every 2 months for the first 6 months, then every 6 months for two years
High Density Lipoproteins
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), greater than 40 mg/dl
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Low Density lipoproteins
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), less than 100 mg/dl
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Protein C Reactive
It will be measured by a blood tests, unit mg/dl (miligrams/ deciliters), less than 10 mg/dl
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Thyroid stimulating hormone
It will be measured by a blood tests, unit IU/L (interantional unit/ liters), from 0.3 to 3 IU
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Triiodothyronine
It will be measured by a blood tests, unit IU/L (nanograms/ mililiters), from 0.8 to 2 ng/ml
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Thyroxine
It will be measured by a blood tests, unit pg/ml (picograms/ mililiters), from 5.4 to 11.5 pg/ml
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Cholecalciferol
It will be measured by a blood tests, unit ng/ml (nanograms/ mililiters), from 25 to 90 ng/ml
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Gasometric variables, Partial pressure of oxygen (PaO2)
It will be measured by a blood tests, unit mmHg (milimeters of mercury), minimum 75, maximum 100
Measured: Every 2 months for the first 6 months, then every 6 months for two years
HCO3 (Bicarbonate ion plasma concentration)
It will be measured by a blood tests, unit mEq/L (miliequivalents per litre), minimum 21, maximum 30
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Arterial pH
It will be measured by a blood tests, minimum 7.35, maximum 7.45
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Lactic acid
It will be measured by a blood tests, unit mg/L (miligrams/liters), from 4.5 to 19 mg/L
Measured: Every 2 months for the first 6 months, then every 6 months for two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start15 Jan 2021
- Primary completion30 Dec 2021
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Clinical Trial was conducted in patients with obesity type I patients
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Veracruzana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco J. Nachón García, Universidad Veracruzana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275347
- Sponsor's protocol ID
- 19CI 30 087 041
- Other IDs
- 1/1142021
- Acronym
- Zelé2021
- Status last verified
- Feb 2024
- First submitted
- 8 Dec 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 4037162Hemmingsson 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.
PubMed 22990030Lartey 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.
PubMed 32994229Foster 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.
PubMed 29151714Pirozzo 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.
PubMed 12760443Blackburn 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.
PubMed 817237Tsai 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.
PubMed 16988070Goday 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.
PubMed 27643725Elfhag 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.
PubMed 20223613Handjieva-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.
PubMed 20588292Nackers 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.
PubMed 20443094Blackburn 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.
PubMed 23034956Larsen 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.
PubMed 21105792Cano-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
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.
PubMed 18330140
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Response to Weight Loss and Metabolic Conditions Using Two Non-pharmacological Nutritional Programs
- ClinicalTrials.gov ID
- NCT06275347
- Acronym / sponsor ID
- Zelé2021 / 19CI 30 087 041
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Universidad VeracruzanaUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A Randomized Clinical Trial was conducted in patients with obesity type I patients
| Arm | Type | Receives |
|---|---|---|
| Intervention Very low calorie ketogenic low-fat diet (VLCKLFD) | Experimental | Other: 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) | Active comparator | Other: Hypocaloric Balanced DietThe 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 |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-fat normoprotein Controlled Ketogenic Diet.Also: ZeléFrank 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 | Intervention Very low calorie ketogenic low-fat diet (VLCKLFD) |
| Hypocaloric Balanced DietAlso: Low-Calorie Diet (CD)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 | Low-Calorie Diet (LCD) |
Primary outcome
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.
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
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
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
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
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
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
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
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
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
Height
Time frame: Every week for 4 months, then every month for two years
The size will be measured in meters with a stadiometer
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.
33 secondary outcomes
Hemoglobin
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Hematocrit
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Leukocytes
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Fasting Blood Glucose
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Glycated hemoglobin (HbA1c)
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Insulin
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Creatinine
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Urea
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Uric acid
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Sodium
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Potassium
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Calcium
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Phosphorus
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Magnesium
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Albumin
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Direct bilirubin
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Indirect bilirubin
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Total bilirubin
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Alanine aminotransferase
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Aspartate Amino Transferase
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Total cholesterol
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Triglycerides
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
High Density Lipoproteins
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Low Density lipoproteins
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Protein C Reactive
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Thyroid stimulating hormone
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Triiodothyronine
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Thyroxine
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Cholecalciferol
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Gasometric variables, Partial pressure of oxygen (PaO2)
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
HCO3 (Bicarbonate ion plasma concentration)
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Arterial pH
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Lactic acid
Time frame: Every 2 months for the first 6 months, then every 6 months for two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 4037162Palgi 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.
- Background: PubMed 22990030Hemmingsson 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.
- Background: PubMed 32994229Lartey 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.
- Background: PubMed 29151714Foster 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.
- Results publication: PubMed 12760443Pirozzo 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.
- Results publication: PubMed 817237Blackburn 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.
- Results publication: PubMed 16988070Tsai 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.
- Results publication: PubMed 27643725Goday 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.
- Results publication: PubMed 20223613Elfhag 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.
- Results publication: PubMed 20588292Handjieva-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.
- Results publication: PubMed 20443094Nackers 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.
- Results publication: PubMed 23034956Blackburn 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.
- 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.Link provided by the sponsor.
- Initial weight loss is the best predictor for success in obesity treatment and sociodemographic liabilities increase risk for drop-outLink provided by the sponsor.
- Initial weight loss on an 800-kcal diet as a predictor of weight loss success after 8 weeks: the Diogenes study.Link provided by the sponsor.
- The association between rate of initial weight loss and long-term success in obesity treatment: Does slow and steady win the race?Link provided by the sponsor.
- Weight of the nation: moving forward, reversing the trend using medical careLink provided by the sponsor.
- Dietas bajas en hidratos de carbono frente a dietas bajas en grasas.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypocaloric Balanced Diet in people with Obesity, run by Universidad Veracruzana at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of this nutritional intervention (time frame: Every week for 4 months, then every month for two years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06275347, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.