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Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD)

NCT06275347 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-02-23

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Universidad Veracruzana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2021-12-30
Completion
2023-05-25

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06275347 on ClinicalTrials.gov