A Study to Explore the Feasibility of Consumption of Specific Complex Amino Acid Supplementation in the Form of an Oral Gel With Additional Leucine (40%) and Vitamin D in Patients With Primary Ciliary Dyskinesia: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percentage consumption of supplement gels
研究概览
简要总结
Feasibility study to understand and gain preliminary information on tolerability and palatability of an oral nutritional supplement gel in a clinical Primary Ciliary Dyskinesia population. To determine if dietary intake is affected by the consumption of the nutritional supplement.
Explore possible future outcome measures that could be important in determining impact of this nutritional intervention on this patient group.
Participants will be provided with the gel supplements and alongside will have other standard and non standard care measures assessed lung function (FEV1%) number of exacerbation's during study period vitamin D status Bio impedance analysis (BIA) skin-fold measures (e.g. Tricep Skin-fold (TSF) Mid upper arm circumference (MUAC) Handgrip strength (HGS) quality of life measures 6-minute walking tests. Hypothesis Patients with PCD can successfully consume 2 gel supplements per day for a period of 3 months with no effect on dietary intake.
详细描述
This is a single site study taking place in a regional PCD clinic. Participants are screened via patient online data system by lead consultants and contacted via telephone to outline study and provide information and contact for queries. participant information sheet and pre-test guidance to be sent to participant prior to next scheduled clinic appointment.
Participants attend their usual clinic appointments where routine care measures are completed by healthcare assistants and lead consultants. They then have opportunity to ask study coordinator any questions and complete consent for additional measures to be recorded.
This is followed by a trial of the supplement to check for immediate tolerance followed by completion of consent to partake in study and initial palatability and acceptability records.
3 month supply of supplement is provided along with storage and consumption instructions (consume 1 at breakfast and 1 at lunch) a waste box to retain consumed sachets and record time of consumption. Additional telephone appointment made for 1 month to collect further palatability and acceptability along with dietary 24 hour recall.
Participant is contacted via telephone at month 1 and 2 to recheck tolerability, acceptability, palatability and dietary intake. Participant can withdraw at any time if unable to continue to tolerate gel supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People aged 17 or over with a confirmed diagnosis of Primary ciliary dyskinesia PCD (nasal brushings)
- •People who attend the Leeds Regional PCD Clinics
- •People who have capacity to give informed consent
排除标准
- •People who are pregnant
- •Those with existing co-morbidities such as malignancy
- •People with connective tissue disorders and immunoglobulin deficiencies
- •People with renal insufficiency r
结局指标
主要结局
Percentage consumption of supplement gels
时间窗: 3 months
To measure through percentage (%) consumed by return of empty sachets over period of three months for each participant
Assessment of palatability of supplement gels
时间窗: 3 months
To measure using hedonic rating scale (like a lot, like a little, neither like nor dislike, dislike a little, dislike a lot) the appearance, aroma, taste, sweetness, texture mouth feel over the study period of 3 months for each participant
Measurement of dietary intake
时间窗: 3 months
To collect dietary intake at monthly intervals (baseline, one, two and three) using multiple pass 24 hour recalls conducted through face to face and telephone interviews at each time point recording all food and drink consumption. This is then analysed via Nutritics software, for each participant
次要结局
- Vitamin D levels(3 months)
- Tricep skinfold measure(3 months)
- Six minute walk tests(3 months)
- Lung Function (Forced Expiratory Volume1 %, Forced Vital Capacity %)(3 months)
- Body Mass Index(3 months)
- Number of infections over study period(3 months)
- Quality of life outcome SF-36 questionnaire(3 months)
- Quality of Life outcome St Georges Respiratory Questionnaire(3 months)
- Hand grip strength dynamometry(3 months)
- Mid upper arm circumference(3 months)
- Habitual activity estimation scale (HAES)(3 months)
- Medical Research Council (MRC) breathlessness score(3 months)
- Bio electrical impedance analysis(3 months)
研究者
Professor Daniel G Peckham
Professor of Respiratory Medicine
University of Leeds