Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD) (Zelé2021)

Universidad Veracruzana

Status: Completed

Conditions: Obesity

Treatments: Other: Hypocaloric Balanced Diet; Other: Low-fat normoprotein Controlled Ketogenic Diet.

Study type: Interventional

Funder types: Other

Identifiers

NCT06275347

1/1142021 (Other Identifier)

19CI 30 087 041

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 61 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Low-fat normoprotein Controlled Ketogenic Diet.

Low-Calorie Diet (LCD)

Active Comparator group

Description:

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

Treatment:

Other: Hypocaloric Balanced Diet