NCT04223206已完成不适用
K2DTD75 - ALTIS "Alimento Funzionale a Base di Lens Culinaris Tipico Del Territorio Pugliese ed Innovativo Per la Salute" - Regione Puglia "INNONETWORK 2017"
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation of muscle mass
研究概览
简要总结
The objective of the pilot study is to validate the clinical use of a dietary supplement for contrasting sarcopenia in dialysis patients.
The study aims at evaluating the effects of a nutritional supplement, consisting of flour from Lens culinaris of Altamura IGP, pea proteins and vitamins (A, B12, D, E) by achieving the following objectives:
- Reduction of sarcopenia conditions, through improvement of nutritional and anthropometrical levels
- Decrease of the serum levels of microbiota-derived uremic toxins
- Reduction of intestinal permeability and inflammatory markers
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients > 60 years old
- •omnivore controlled normocaloric diet (30 Kcal/kg ideal weight)
- •patients with chronic kidney disease (CKD) and routine hemodialysis or peritoneal dialysis
- •patients with primary sarcopenia identified with score ≥ 4 at SARC-F Questionnaire
- •informed consent signed
排除标准
- •participation to another clinical trial
- •limb removal by amputation
- •altered blood sugar level (HbA1c>8.0%) or type I diabetes mellitus
- •neoplastic events in the last 5 years
- •gut, systemic or autoimmune chronic inflammatory pathologies
- •use of antibiotics or probiotics up to 30 days prior to recruitment
- •life expectancy of less than one year
- •treatment with corticosteroids or immunosuppressive drugs (excluded prednisone at dose <5 mg at day)
- •positivity to hepatitis B and C virus, HIV1/2 and syphilis
- •oxygen saturation in the blood at rest <93%
- •alcohol or drug abuse in the last 3 years
- •clinically important alterations of the following laboratory parameters: hemoglobin <9.0 g / dL, white blood cells <2.500 / μl, platelet count <100.000 / μl, AST and ALT> 3 times the upper limit of the norm, coagulopathy (INR> 1.3 ) not due to a reversible cause (eg Warfarin and / or factor Xa inhibitors)
- •uncontrolled hypertension (resting systolic blood pressure> 180 mmHg or diastolic blood pressure> 110 mmHg)
- •unstable angina pectoris, severe peripheral artery disease, coronary bypass surgery, angioplasty or acute major cardiocirculatory diseases in the previous 3 months
- •definite congestive heart failure class III or IV (NYHS) or ejection fraction <25%
- •severe pulmonary dysfunction: acute exacerbation of chronic obstructive pulmonary disease in phase III or IV (Gold classification) and / or PaO2 levels <60 mmHg
- •significant intestinal malabsorption due to partial ileal bypass or other causes
- •score ≤ 24 at the Mini Mental State Examination (MMSE) or presence of cognitive or linguistic limits that prohibit informed consent or possible elements of study
- •diagnosis of disabling neurological disorder, including Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (for example, muscle weakness or gait disorder), dementia or any psychiatric condition that reduces protocol compliance
- •have a history or evidence of any condition, therapy, laboratory abnormality or other circumstances that could confuse the results of the study or interfere with the patient's participation throughout the duration of the study
结局指标
主要结局
Evaluation of muscle mass
时间窗: 3 months
Change of muscle mass by bioelectrical impedance assessment (BIA)
次要结局
- Change of serum concentration of D-lactate(3 months)
- Change of Mini Nutritional Assessment (MNA) score(3 months)
- Change of anthropometric parameter(3 months)
- Change of body mass index (BMI)(3 months)
- Change of gastrointestinal symptoms(3 months)
- Change of serum concentration of inflammatory markers(3 months)
- Change of sarcopenia conditions(3 months)
- Change of stool type(3 months)
- Change of serum concentration of IS and pCS(3 months)
- Change of blood glucose level(3 months)
- Change of insulin levels(3 months)
- Change of endocrine parameters(3 months)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection.HPV InfectionNCT06285357Lo.Li.Pharma s.r.l100
招募中
不适用
A Pilot Study to Evaluate the Systemic Effect of Oral Supplementation With AM3 in Patients With Metabolic Syndrome.Metabolic SyndromeNCT06158152Industrial Farmacéutica Cantabria, S.A.48
已完成
不适用
Study to Evaluate the Safety and Efficacy of a Proprietary "Joint Health" Dietary Supplement in Subjects With Joint and Connective Tissue PainJoint PainNCT03209895U.S. Nutraceuticals, LLC135
进行中（未招募）
2 期
SIALIDASE INHIBITION AS ANTIATHEROSCLEROTIC THERAPYAtherosclerosisAtheroscleroses, CoronaryCarotid AtherosclerosisNCT06590012Institute for Atherosclerosis Research, Russia1,228
已完成
1 期
Anaplerotic Therapy in Propionic AcidemiaPropionic AcidemiaNCT00645879Nicola Longo3