Assessment of Tolerability of Specialized Foods of Vegetable Proteins and Their Influence on Lipid Profile in Patients With Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- cholesterol
研究概览
简要总结
To this single-centre randomized controlled comparative study it is planned to enroll 50 patients with non-alcoholic fatty liver disease. All these subjects will receive standard isocaloric diet for 14 days. Subjects of the main group will receive vegetable protein-and-fat cutlet or schnitzel insted of the same amount of standard (animal meat based) cutlet or schnitzel. Subjects of the control group will receive standard diet, with cutlets or schnitzels made of animal meat. It is planned to make repeated measurements of serum lipid profile and assess general well-being and tolerability of newly developed product compared to regular meal
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Chicken-flavoured plant-based meat analogs will be used in this study
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate;
- •Confirmed diagnosis of non-alcoholic fatty liver disease based on EASL guidelines.
排除标准
- •Pregnancy and breastfeeding;
- •excessive alcohol intake (>20 g/day women and >30 g/day men)
- •Liver cirrhosis based on liver histology, or liver stiffness measurement (LSM > or =14 kPa by Fibroscan), or APRI > or= 1; or BARD score > or =
- •Chronic heart failure (I-IV class by NYHA).
- •Past bariatric surgery.
- •Clinically relevant acute cardiovascular event within 6 months prior to screening.
- •Uncontrolled arterial hypertension despite optimal anti-hypertensive therapy.
- •Diabetes mellitus type
- •Serum glycated hemoglobin [HbA1c] concentrations >9.0%.
- •Hypersensitivity to the studied product or any of its components.
- •The intake of any medications that may affect the absorption, distribution, metabolism or excretion of investigational products or may lead to the induction or inhibition of microsomal enzymes (for example, indomethacin) - from the moment of randomization to the end of treatment.
- •Any medical conditions that may significantly affect life expectancy, including known cancers;
- •Any clinically significant immunological, endocrine, haematological, gastrointestinal, neurological or psychiatric diseases;
- •Mental instability or incapacity, which may impact the ability to give informed consent, take part in the study, or affect the ability to comply with study protocol requirements.
- •Positive test for to human immunodeficiency virus antibodies .
- •Aspartate aminotransferase (AST) and/or ALT >10 x upper normal limits.
- •conjugated bilirubin > 26 mcmol/l (patients with Gilbert's disease are allowed to the study).
- •International normalized ratio >1.
- •Platelet count <100 x10^9/L due related to portal hypertension.
- •Clinically relevant renal dysfunction, including nephrotic syndrome, chronic kidney disease (determined based on the estimated glomerular filtration rate [eGFR] less than 60 ml/min/1.73 m^2).
研究组 & 干预措施
Control - standard iso-calorie diet
Iso-calorie diet (based on resting energy expenditures measurements) is provided to subjects with non-alcoholic fatty liver disease
干预措施: standard isocalorie diet (Other)
plant-based meat analog
Patients with non-alcoholic fatty liver disease will receive iso-caloric diet with modified fat and protein content: 18.8 g/day animal proteins a day will be substituted by 13.0 g/day vegetable protein; 6.0 g/day animal fat will be substituted by 19.1 g/day vegetable fat. This modification undermines substitution of a portion of meat product made of standard (animal) meat (cutlet or schnitzel) by plant-based analog, based on soy-bean source. The taste will be masked by natural food flavoring (taste of chicken).
干预措施: Specialized food - Plant-Based Meat Analog (Other)
结局指标
主要结局
cholesterol
时间窗: baseline and day 14
serum cholesterol change
C-reactive protein
时间窗: baseline and day 14
Serum concentration of C-reactive protein change
stool form
时间窗: baseline and day 14
Stool form change assessed with standard Bristol stool scale. Type 1 is characterized by separate hard lumps, hard to pass; this often observed in constipation; Type 4 - looks like a sausage or snake, smooth and soft (normal); Type 7 - watery, entirely liquid stool, observed in diarrhea; Mean values of stool forms by previous 7 days at baseline and on day 14 will be assessed to reflect a "change".
Low-density lipoproteins
时间窗: baseline and day 14
Serum concentrations of low-density lipoproteins change
High-density lipoproteins
时间窗: baseline and day 14
Serum concentration of HDLP change
triglycerides
时间窗: baseline and day 14
Serum concentration of triglycerides change
urea
时间窗: baseline and day 14
serum concentration of urea change
Organoleptic qualities of the developed products
时间窗: baseline and day 14
Organoleptic assessment with the use of visual analogue scales (taste, colour, scent, texture) is to be used.
stool frequency
时间窗: baseline and day 14
Mean stool frequency a day will be assessed at baseline and at the end of the study period to detect possible "change" in bowel habits related to product use
次要结局
未报告次要终点