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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
| Aristotle University Of Thessaloniki | OTHER |
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The aim of the study is to compare the implementation of a high-protein diet based on plant-based foods (Group A) with the usual guidelines for liver patients, in which protein needs are met by low-fat animal foods (Group B). The parameters that will be studied concern:
3. Muscular system functionality and sarcopenia 4. The intestinal microbiome 5. The quality of life of the patients
This is a randomized, double-blind intervention study lasting 6 months, during which volunteers will be asked to answer, with the help of the researchers, questionnaires assessing nutritional risk, assessing physical activity and quality of life, and assessing nutritional intake (24-hour food recall and Food Frequency Questionnaire). At the same time, a blood sample will be collected for analysis of inflammatory factors and indicators related to nutritional status (albumin, prealbumin, cholesterol, total iron binding capacity). Body composition will be assessed using the method of anthropometry and dual-energy X-ray absorptiometry (DEXA), and hand dynamometry to assess functionality. The assessment of the microbiome will be performed by saliva collection and/or stool collection. The impact on liver function will be assessed by recording every 3 months a) natriuresis/microalbuminuria (in 24-hour urine collection or urine sample) and the severity of ascites (grade I, II, III), b)ammonia levels and episodes of encephalopathy, c) complications of cirrhosis, such as variceal hemorrhage, encephalopathy, spontaneous bacterial peritonitis and renal dysfunction, d) liver disease severity assessment scores, such as MELD and Child-Pugh scores.
The aim of the study is to see if there is a difference in sarcopenia and the values of various biochemical indicators between patients who received plant-based proteins compared to patients who received animal-based proteins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (diet with animal protein). | Experimental | In group Α, a diet was designed based on the needs of each individual, based on proteins of animal origin. |
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| Group B (diet with plant based protein). | Experimental | In group B, a diet was designed based on the needs of each individual, based on proteins of plant origin. |
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| Group C (control) | Other | Control group who were given general instructions for patients with liver disease. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet based on animal proteins | Other | Ιntervention with a diet based on animal proteins. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric measurements | The following parameters will be measured and combined into various equations to evaluate the body weight and body composition of each patient, body weight (kg) , height (m^2) , mid-arm circumference (cm) , skinfolds (mm), dynamometry and biochemical/hematological testing were performed. | From the first day and 3 months later |
| Quality of life (QoL) assessment | Quality of life (QoL) was assessed with the SF-36 questionnaire. | From the first day and 3 months later |
| Dietary compliance | Dietary compliance was assessed with 24-hour recalls and a food frequency questionnaire. | From the first day and 3 months later |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laikon General Hospital of Athens | Recruiting | Athens | Attica | 11527 | Greece |
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Double Blind randomized clinical trial
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| Diet based on plant proteins. | Other | Ιntervention with a diet based on animal proteins. |
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| General instructions for patients with liver disease. | Other | Α brochure with general instructions was designed for patients with liver disease. |
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| Agricultural University of Athens | Recruiting | Athens | Attica | 11855 | Greece |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D055948 | Sarcopenia |
| D044342 | Malnutrition |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D013851 | Thinness |
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