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临床试验/NCT07028580
NCT07028580招募中不适用

Evaluation of a High Protein Plant Dominant Diet (HiProPlaDo) in Sarcopenia, Quality of Life and Metabolic Parameters in Patients With Liver Cirrhosis: A Randomized Clinical Trial

Agricultural University of Athens2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Anthropometric measurements

研究概览

简要总结

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:

  1. Liver function

  2. Nutritional status and the risk of malnutrition

  3. Body composition, with emphasis on muscle mass

  4. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients with decompensated cirrhosis awaiting kidney transplantation who have not previously received dietary advice.

排除标准

  • •Psychopathological illness
  • •Adoption of a vegetarian diet prior to study entry
  • •Hepatonephrotic syndrome requiring protein restriction

研究组 & 干预措施

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.

干预措施: Diet based on animal proteins (Other)

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.

干预措施: Diet based on plant proteins. (Other)

Group C (control)

Other

Control group who were given general instructions for patients with liver disease.

干预措施: General instructions for patients with liver disease. (Other)

结局指标

主要结局

Anthropometric measurements

时间窗: From the first day and 3 months later

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.

Quality of life (QoL) assessment

时间窗: From the first day and 3 months later

Quality of life (QoL) was assessed with the SF-36 questionnaire.

Dietary compliance

时间窗: From the first day and 3 months later

Dietary compliance was assessed with 24-hour recalls and a food frequency questionnaire.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kalliopi Anna Poulia

Assistant Professor in Clinical Dietetics

Agricultural University of Athens

研究点 (2)

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