Comparative Study of the Response to Weight Loss and Metabolic Conditions Using Two Non-pharmacological Nutritional Programs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad Veracruzana
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Bone mass
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to 61 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Intervention Very low calorie ketogenic low-fat diet (VLCKLFD)
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.
Intervention: Low-fat normoprotein Controlled Ketogenic Diet. (Other)
Low-Calorie Diet (LCD)
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
Intervention: Hypocaloric Balanced Diet (Other)
Outcomes
Primary Outcomes
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
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
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
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.
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
Height
Time Frame: Every week for 4 months, then every month for two years
The size will be measured in meters with a stadiometer
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
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
BMI Body index mass
Time Frame: Every week for 4 months, then every month for two years
Body mass index is an index composed of weight/height squared in kg/m2.
Secondary Outcomes
- 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)
- Glycated hemoglobin (HbA1c)(Every 2 months for the first 6 months, then every 6 months for two years)
- Calcium(Every 2 months for the first 6 months, then every 6 months for two years)
- Potassium(Every 2 months for the first 6 months, then every 6 months for two years)
- Phosphorus(Every 2 months for the first 6 months, then every 6 months for two years)
- Indirect bilirubin(Every 2 months for the first 6 months, then every 6 months for two years)
- Aspartate Amino Transferase(Every 2 months for the first 6 months, then every 6 months for two years)
- Thyroid stimulating hormone(Every 2 months for the first 6 months, then every 6 months for two years)
- Lactic acid(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)
- Insulin(Every 2 months for the first 6 months, then every 6 months for two years)
- Urea(Every 2 months for the first 6 months, then every 6 months for two years)
- Albumin(Every 2 months for the first 6 months, then every 6 months for two years)
- Direct bilirubin(Every 2 months for the first 6 months, then every 6 months for two years)
- High Density Lipoproteins(Every 2 months for the first 6 months, then every 6 months for two years)
- HCO3 (Bicarbonate ion plasma concentration)(Every 2 months for the first 6 months, then every 6 months for two years)
- Arterial pH(Every 2 months for the first 6 months, then every 6 months for two years)
- Hemoglobin(Every 2 months for the first 6 months, then every 6 months for two years)
- Uric acid(Every 2 months for the first 6 months, then every 6 months for two years)
- Magnesium(Every 2 months for the first 6 months, then every 6 months for two years)
- Total bilirubin(Every 2 months for the first 6 months, then every 6 months for two years)
- Total cholesterol(Every 2 months for the first 6 months, then every 6 months for two years)
- Gasometric variables, Partial pressure of oxygen (PaO2)(Every 2 months for the first 6 months, then every 6 months for two years)
- Alanine aminotransferase(Every 2 months for the first 6 months, then every 6 months for two years)
- Creatinine(Every 2 months for the first 6 months, then every 6 months for two years)
- Sodium(Every 2 months for the first 6 months, then every 6 months for two years)
- Protein C Reactive(Every 2 months for the first 6 months, then every 6 months for two years)
- Triiodothyronine(Every 2 months for the first 6 months, then every 6 months for two years)
- Triglycerides(Every 2 months for the first 6 months, then every 6 months for two years)
- Low Density lipoproteins(Every 2 months for the first 6 months, then every 6 months for two years)
- Thyroxine(Every 2 months for the first 6 months, then every 6 months for two years)
- Cholecalciferol(Every 2 months for the first 6 months, then every 6 months for two years)
Investigators
Francisco J. Nachón García
MD. PhD Senior Researcher of the Institute of Health Sciences at Universidad Veracruzana Xalapa
Universidad Veracruzana