NCT06275347

Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD)

Comparative Study of the Response to Weight Loss and Metabolic Conditions Using Two Non-pharmacological Nutritional Programs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Universidad Veracruzana · Academic / Other
• Sex: All
• Age: 18 Years – 61 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
OTHER	Low-fat normoprotein Controlled Ketogenic Diet.	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.
OTHER	Hypocaloric Balanced Diet	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

Timeline

• Start date: 2021-01-15
• Primary completion: 2021-12-30
• Completion: 2023-05-25
• First posted: 2024-02-23
• Last updated: 2024-02-23

Locations

1 site across 1 country: Mexico