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| Name | Class |
|---|---|
| Francesco Russo | UNKNOWN |
| Giuseppe, Riezzo | UNKNOWN |
| Michele, Linsalata | UNKNOWN |
| Antonella, Orlando |
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This study is open label, with one arm only. In this study will be enrolled patients with obesity (BMI more than 30). Aim of the study is to determine the influence (if any) of a very low calorie ketogenic diet (VLCKD) on gut permeability and liver steatosis.
The first objective is to examine the influence of obesity on the prevalence and severity of impaired intestinal permeability and hepatic steatosis.
Intestinal permeability means the ability of the intestinal barrier to block the passage of substances potentially harmful to our body.
The second objective is to evaluate whether a low-calorie and ketogenic dietary intervention, lasting 6 weeks, can change intestinal permeability and hepatic steatosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention arm with VLCKD | Experimental | all patients will receive a very low calorie Ketogenic diet (VLCKD) and will be followed for all the time of the study, monitoring gut permeability, liver steatosis and microbiome composition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic Diet | Dietary Supplement | all patients will receive a very low calorie ketogenic diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut permeability | examine the influence of obesity on possible alterations (if any) in intestinal permeability. subjects drank a sugar test solution containing 10 g of lactulose, 5 g of mannitol, and 40 g of sucrose in a volume of 100 ml. Urine samples were collected up to 5 h after administration. . Te percentage of ingested La (%La), Ma (%Ma), and Su (%Su) were evaluated in urine, and the La/Ma ratio was calculated for each sample. Patients with a La/Ma ratio higher than 0.030 were considered as having an altered gut permeability | 6 weeks |
| Gut Dysbiosis | evaluate the impact of the low-calorie and ketogenic diet on possible alterations of the intestinal microbiome. The dysbiosis test is based on urinary quantification of two metabolites deriving from the decomposition of tryptophan, skatole (3-methyl-indole), and indican. Urinary indican and skatole were considered normal at values lower than 10 mg/L and 10 µg/L, respectively. Urinary concentrations of indican and skatole higher than 20 mg/L and 20 µg/L indicate the presence of fermentative and putrefactive grade I dysbiosis, respectively | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni De Perogla, Prof | Contact | 0804994635 | giovanni.depergola@irccsdebellis.it |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni De Pergola, Prof | IRCCS "Saverio de Bellis" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs Saverio de Bellis | Recruiting | Castellana Grotte | BARI | 70013 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29984492 | Result | Genser L, Aguanno D, Soula HA, Dong L, Trystram L, Assmann K, Salem JE, Vaillant JC, Oppert JM, Laugerette F, Michalski MC, Wind P, Rousset M, Brot-Laroche E, Leturque A, Clement K, Thenet S, Poitou C. Increased jejunal permeability in human obesity is revealed by a lipid challenge and is linked to inflammation and type 2 diabetes. J Pathol. 2018 Oct;246(2):217-230. doi: 10.1002/path.5134. Epub 2018 Aug 28. | |
| 28049662 |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
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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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| UNKNOWN |
| Benedetta, D Attoma | UNKNOWN |
| Laura, Prospero | UNKNOWN |
| Antonia, Ignazzi | UNKNOWN |
| Sara, De Nucci | UNKNOWN |
| Raffaele, Cozzolongo | UNKNOWN |
| Vito, Giannuzzi | UNKNOWN |
| Maria, De Angelis | UNKNOWN |
| Giusy Rita, Caponio | UNKNOWN |
| Oronzo, Milella | UNKNOWN |
| Gianluigi, Giannelli | UNKNOWN |
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| Result |
| Damms-Machado A, Louis S, Schnitzer A, Volynets V, Rings A, Basrai M, Bischoff SC. Gut permeability is related to body weight, fatty liver disease, and insulin resistance in obese individuals undergoing weight reduction. Am J Clin Nutr. 2017 Jan;105(1):127-135. doi: 10.3945/ajcn.116.131110. Epub 2016 Nov 9. |
| 32922055 | Result | Mkumbuzi L, Mfengu MMO, Engwa GA, Sewani-Rusike CR. Insulin Resistance is Associated with Gut Permeability Without the Direct Influence of Obesity in Young Adults. Diabetes Metab Syndr Obes. 2020 Aug 24;13:2997-3008. doi: 10.2147/DMSO.S256864. eCollection 2020. |
| 28931850 | Result | Ott B, Skurk T, Hastreiter L, Lagkouvardos I, Fischer S, Buttner J, Kellerer T, Clavel T, Rychlik M, Haller D, Hauner H. Effect of caloric restriction on gut permeability, inflammation markers, and fecal microbiota in obese women. Sci Rep. 2017 Sep 20;7(1):11955. doi: 10.1038/s41598-017-12109-9. |
| 33882506 | Result | Muscogiuri G, El Ghoch M, Colao A, Hassapidou M, Yumuk V, Busetto L; Obesity Management Task Force (OMTF) of the European Association for the Study of Obesity (EASO). European Guidelines for Obesity Management in Adults with a Very Low-Calorie Ketogenic Diet: A Systematic Review and Meta-Analysis. Obes Facts. 2021;14(2):222-245. doi: 10.1159/000515381. Epub 2021 Apr 21. |
| D044343 |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| 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 |