The Effect of Targeted Nutrient Supplementation on Physical Activity and Healthy Related Quality of Life in COPD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Change in generic health status measured by EuroQol-5 dimensions (EQ-5D)
研究概览
简要总结
The overall objective is to investigate the efficacy of targeted nutrient supplementation on daily physical activity level as well as generic health status in patients with COPD. Additionally the investigators aim to investigate the relative effect of targeted nutrient supplementation on the recovery after hospitalization for a COPD exacerbation. The secondary objective is to investigate the effect of targeted nutrient supplementation on mental health, physical performance, blood markers, patient related outcomes and gut health. Additionally, a secondary objective is to compare the gut microbiome composition of patients with COPD compared to healthy controls.
详细描述
Rationale: Impaired physical and mental health are common features in COPD adversely affecting disease course and quality of life. Furthermore, nutritional status is often impaired due to dietary and plasma nutrient deficiencies, decreased muscle oxidative metabolism and impaired intestinal permeability. The investigators hypothesize that targeted nutrient supplementation can lead to gut-muscle-brain axis-mediated amelioration of physical, cognitive and mental health domains, resulting in a healthier lifestyle, in patients with COPD.
Study design: Randomized, placebo-controlled, double-blind trial.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The nutrient supplement is hypothesized to have beneficial effects on general health because it applies physical and mental health domains. The healthy lifestyle counselling aims to improve medical adherence, to address a healthier lifestyle and to manage weight loss which would contribute to improved general health. Risks and inconveniences are limited to the time investment associated with taking the supplements and measuring days. During the test-days various non-invasive measurements as well as minor invasive blood sampling will be performed. The investigators expect no risk of the nutrient supplementation. Healthy controls will only attend a subgroup of baseline measurements which are limited to non-invasive measurements and one minor invasive blood sampling. Healthy controls will not receive the nutritional supplement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD Patients:
- •COPD patients with moderate to very severe disease stage according to GOLD criteria (i.e. GOLD stage II-IV);
- •Medically stable.
排除标准
- •COPD Patients:
- •Age <18 years;
- •Allergy or intolerance to components of the study product;
- •Not willing or not able to quit vitamin D or fatty acid supplement intake;
- •Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment);
- •Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study;
- •Patients with terminal illness;
- •Recent hospital admission (<4 weeks prior to the start of the study);
- •Temporary oral steroid or antibiotics use due to a COPD exacerbation in the last 4 weeks;
- •Lung malignancy in the previous 5 years;
- •Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records;
- •Recent diagnosis of cerebral conditions (<1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records;
- •Any medical condition that significantly interferes with digestion and/or gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator.
- •Inclusion Criteria Healthy Controls
- •Forced expiratory volume in 1 second/Forced vital capacity > 0.7;
- •Medically stable.
- •Exclusion Criteria Healthy Controls
- •Age <18 years;
- •Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements (e.g. leg amputation) or patients suffering from other acute or unstable chronic diseases that will compromise the study outcome (e.g. active cancer requiring treatment);
- •Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study;
- •Patients with terminal illness;
- •Recent hospital admission (<4 weeks prior to the start of the study);
- •Temporary antibiotics use in the last 4 weeks;
- •Lung malignancy in the previous 5 years;
- •Diagnosis of dementia or neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, Huntington's chorea, frontotemporal dementia) in the medical records;
- •Recent diagnosis of cerebral conditions (<1 year e.g. cerebral infarction, hemorrhage, brain tumors, transient ischemic attack) in the medical records;
- •Any medical condition that significantly interferes with digestion and/or gastrointestinal function (e.g. short bowel syndrome, inflammatory bowel disease, gastric ulcers, gastritis, (gastro)-enteritis, GI-cancer) as judged by the investigator.
- •Diagnosis of any chronic lung disease.
研究组 & 干预措施
Group Long-drink
83 COPD patients will receive:
- Targeted nutrient supplementation (Long-drink) once daily
- Counselling once monthly
干预措施: Targeted nutrient supplementation (Long-drink) (Dietary Supplement)
Group Long-drink
83 COPD patients will receive:
- Targeted nutrient supplementation (Long-drink) once daily
- Counselling once monthly
干预措施: Counselling (Behavioral)
Group Placebo
83 COPD patients will receive:
- Isocaloric placebo supplement once daily
- Counselling once monthly
干预措施: Placebo supplement (Dietary Supplement)
Group Placebo
83 COPD patients will receive:
- Isocaloric placebo supplement once daily
- Counselling once monthly
干预措施: Counselling (Behavioral)
Healthy control group
30 healthy controls will be included for baseline comparison of the microbiome composition. These healthy controls will only perform a subset of baseline measurements and will not be included in the intervention.
结局指标
主要结局
Change in generic health status measured by EuroQol-5 dimensions (EQ-5D)
时间窗: 0, 3, and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later
The EQ-5D is a generic classification system used to characterize current health states of patients. It consists of 5 domains (mobility; self-care; usual activity; pain/discomfort; anxiety/depression) and a visual analogue scale (EQ-VAS). The domains have a scale from 1-3 and the VAS-scale from 0-100 in which higher values represent a better outcome.
Change in physical activity level assessed by measuring step count with accelerometry
时间窗: 0, 3, and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later
Subjects will wear an activPAL accelerometer for 1 week to assess physical activity.
次要结局
- Change in Cohen's Perceived Stress Scale (PSS)(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in cognitive function measured by the Neuropsychological test automated battery (CANTAB)(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in blood pressure after the socially evaluated cold pressure test(0-12 months.)
- Change in hair cortisol(0 and 12-14 months and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in exercise performance by measuring the 6 minute walking distance(0-12 months.)
- Change in weight(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in pain using the Visual Analogue Scale (VAS)(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in intestinal fatty acid binding protein (blood) in rest(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in Depression Anxiety Stress Scale 21 (DASS-21)(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in Hospital and Anxiety Scale (HADS)(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in cortisol in the saliva after the socially evaluated cold pressure test(0-12 months.)
- Change in muscle strength by measuring handgrip strength(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in body composition by performing Dual energy X-ray absorptiometry (DEXA-scan)(0-12 months.)
- Change in height(0-12 months)
- Change in blood markers of systemic inflammation(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in blood markers of gut-muscle-brain cross-talk(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in sleep quality by the Pittsburgh Sleep Quality Index (PSQI)(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in respiratory muscle strength by measuring the inspiratory and expiratory mouth pressure(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in lower extremity performance by the short physical performance battery (SPPB)(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in blood markers of nutritional status(0-3 months; 0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in fatigue by using the checklist individual strength (CIS)(0-12 months; and in case of hospitalization for COPD exacerbation within one week after discharge and 4 weeks later.)
- Change in intestinal fatty acid binding protein (blood) after the 6MWT(0-12 months.)
- Change in gut microbiome composition (optional)(0, 3 and 12 months.)
研究者
Rosanne Beijers
Principal investigator
Maastricht University Medical Center