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Completed

NCT Number: NCT05898204

KEtogenic Diet and Its Multiple EffectS on Obesity

The prevalence of obesity and metabolic disturbances is worryingly increasing worldwide, therefore the study of their pathophysiology is extremely important to find new strategies for their treatment. Obesity has a strong impact not only on the metabolism of the patients, but also may impact hormonal, inflammatory and immune profile, and profoundly influence the daily life of the patients. Weight loss may determine an amelioration of these parameters, but the impact of the diet composition aimed to weight loss on them has not been profoundly studied yet.

The aim of our research project is to study the effects of a ketogenic diet in comparison with an isocaloric balanced diet on weight loss and anthropometric parameters, quality of life, hormone profile, sleep, sexual function, circadian rhythm, inflammatory and immunological parameters in obese patients.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome

Roma, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years
  • BMI≥ 30 Kg/m2

Exclusion criteria

  • Type 1 diabetes mellitus and latent autoimmune diabetes in adults
  • β-cell failure in type 2 diabetes mellitus
  • Use of sodium/glucose cotransporter 2 (SGLT2) inhibitors
  • Pregnancy and breastfeeding
  • Kidney failure and moderate-to-severe chronic kidney disease
  • Liver failure
  • Heart failure (NYHA III-IV)
  • Respiratory failure
  • Unstable angina, stroke or myocardial infarction in the last 12 months
  • Cardiac arrhythmias
  • Eating disorders and other severe mental illnesses, alcohol and substance abuse
  • Active/severe infections
  • Planned elective surgery or invasive procedures
  • Rare disorders: porphyria, carnitine deficiency, carnitine palmitoyltransferase deficiency, carnitine-acylcarnitine translocase deficiency, mitochondrial fatty acid β-oxidation disorders, pyruvate carboxylase deficiency

Treatment and study plan

Ketogenic diet

Other

Prescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.

Balanced Diet

Other

Prescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day.

Primary outcomes

  1. Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Assessment with the questionnaires Impact of weight/Quality of Life-Lite (IWQOL-Lite); global scale from 0 to 100; the higher the score, the better the quality of life

  2. Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Assessment with the questionnaires Short Form Health Survey 36 (SF-36); scale of every item from 0 to 100; the higher the score, the better the quality of life

  3. Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem

Secondary outcomes

  1. Evaluation of weight loss

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Weight loss expressed in Kg

  2. Evaluation of changes of perceived sleep

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Assessment with the questionnaires Pittsburgh Sleep Quality Index; global score on a scale from 0 to 21; the higher the score, the worse the sleep quality

  3. Evaluation of changes of perceived sleepiness

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness

  4. Evaluation of changes in clock genes expression

    Time frame: At baseline, at 30 days

    Evaluation of the expression of the clock genes in blood cells

  5. Evaluation of changes in hormonal profile

    Time frame: At baseline, at 30 days

    Assessment of hormonal parameters, as cortisol, expressed in ug/dL

  6. Evaluation of changes in sexual function in males

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Assessed with the questionnaires International Index of Erectile Function (IIEF-5); scale from 5 to 25; the higher the score, the better the erectile function

  7. Evaluation of changes in inflammation

    Time frame: At baseline, at 30 days, at 60 days if the patient continued the diet

    Measurements of circulating cytokines, as interleukin 2 and interleukin 10, expressed in ng/mL

  8. Evaluation of changes of peripheral blood mononuclear cells

    Time frame: At baseline, at 30 days, at 60 days if the patient continued the diet

    Number of cells of peripheral blood mononuclear cell subpopulations, expressed in number/mm3

  9. Evaluation of changes in sleep parameters (length)

    Time frame: At baseline, at 30 days

    Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes

  10. Evaluation of changes in hip circumference

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Assessment of hip circumference, expressed in cm

  11. Evaluation of changes in waist circumference

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Assessment of waist circumference, expressed in cm

  12. Change in circadian rhythm

    Time frame: At baseline, at 30 days

    Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours

  13. Evaluation of changes in Sexual Function in Females

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Assessed with the questionnaire Female Sexual Function Index (FSFI); scale of every item from 1 to 5; the higher score, the better the sexual function

  14. Evaluation of changes in sleep efficiency

    Time frame: At baseline, at 30 days

    Sleep efficiency expressed as a percentage; measurement with actigraphy

  15. Evaluation of changes in number of awakenings

    Time frame: At baseline, at 30 days

    Measurement with actigraphy

  16. Evaluation of changes in sleep parameters

    Time frame: At baseline, at 30 days

    Evaluation of sleep fragmentation index and movement index, with actigraphy

  17. Evaluation of changes in metabolic parameters

    Time frame: At baseline, at 30 days

    Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L

  18. Evaluation of changes in BMI

    Time frame: At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet

    Weight and height will be combined to report BMI in kg/m^2

  19. Evaluation of height

    Time frame: At baseline

    Assessment of height, expressed in cm

  20. Evaluation of changes in whole blood cells gene expression

    Time frame: At baseline, at 30 days

    Evaluation of the changes in the expression of blood cells genes, as metabolic, inflammatory and immunological genes, with RNA-seq in whole blood cells

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Comparison of the Effects of a Ketogenic Diet and an Isocaloric Balanced Diet in Obese Patients: a Randomized Clinical Trial

Acronym: KEMESO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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