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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic diet arm | Experimental | Ketogenic diet for a month, or a longer period if clinically necessary |
|
| Balanced diet arm | Active Comparator | Balanced diet for a month, or a longer period if clinically necessary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic diet | Other | Prescription of a ketogenic diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of changes in Perceived Quality of Life with IWQOL-Lite Questionnaires | 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 | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes in Perceived Quality of Life with SF-36 Questionnaires | 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 | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes in Perceived Quality of Life with "EQ-5D" Questionnaires | Assessment with the questionnaires "EQ-5D"; scale of every item from 1 to 5; the higher the score, the worse the perceived problem | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of weight loss | Weight loss expressed in Kg | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes of perceived sleep | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome | Roma | Roma | 00161 | Italy |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Patients are sequentially allocated to one of the 2 arms of intervention: the ketogenic diet arm or the balanced diet arm.
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| Balanced diet | Other | Prescription of a balanced diet, 1200 Kcal/die. Patients are encouraged to walk 30 minutes every day. |
|
| At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes of perceived sleepiness | Assessment with the questionnaires Epworth Sleepiness Scale (ESS); score on a scale from 0 to 24; the higher the score, the higher the sleepiness | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes in clock genes expression | Evaluation of the expression of the clock genes in blood cells | At baseline, at 30 days |
| Evaluation of changes in hormonal profile | Assessment of hormonal parameters, as cortisol, expressed in ug/dL | At baseline, at 30 days |
| Evaluation of changes in sexual function in males | 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 | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes in inflammation | Measurements of circulating cytokines, as interleukin 2 and interleukin 10, expressed in ng/mL | At baseline, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes of peripheral blood mononuclear cells | Number of cells of peripheral blood mononuclear cell subpopulations, expressed in number/mm3 | At baseline, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes in sleep parameters (length) | Assessment with actigraphy of latency, total minutes in bed, total sleep time, wake after sleep onset, average awakening length, expressed in minutes | At baseline, at 30 days |
| Evaluation of changes in hip circumference | Assessment of hip circumference, expressed in cm | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes in waist circumference | Assessment of waist circumference, expressed in cm | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Change in circadian rhythm | Evaluation of change in midpoint of sleep, bedtime, sleep onset, rise time and circadian phase, expressed in hours | At baseline, at 30 days |
| Evaluation of changes in Sexual Function in Females | 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 | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of changes in sleep efficiency | Sleep efficiency expressed as a percentage; measurement with actigraphy | At baseline, at 30 days |
| Evaluation of changes in number of awakenings | Measurement with actigraphy | At baseline, at 30 days |
| Evaluation of changes in sleep parameters | Evaluation of sleep fragmentation index and movement index, with actigraphy | At baseline, at 30 days |
| Evaluation of changes in metabolic parameters | Evaluation of changes in metabolic parameters, as glucose, triglycerides, cholesterol and HDL, expressed in mmol/L | At baseline, at 30 days |
| Evaluation of changes in BMI | Weight and height will be combined to report BMI in kg/m^2 | At baseline, at 15 days, at 30 days, at 60 days if the patient continued the diet |
| Evaluation of height | Assessment of height, expressed in cm | At baseline |
| Evaluation of changes in whole blood cells gene expression | Evaluation of the changes in the expression of blood cells genes, as metabolic, inflammatory and immunological genes, with RNA-seq in whole blood cells | At baseline, at 30 days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |