Study of the Efficiency of the Innovative Food Supplement in Improving Nutritional Status of Elderly Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in serum vitamin D levels will be determined
研究概览
简要总结
The aim of this pilot study is to conduct a study on geriatric population in Slovenia (non-users of dietary supplements/medicines with vitamine D, vitamin B12 and protein) and assess deficiency of selected nutrients, and to investigate the efficiency of the innovative food supplement prototype in improving nutritional status of elderly adults.
详细描述
The main objective is to show that in the geriatric population regular use of investigation food supplement would improve nutritional status. The study should provide answers to the following main questions: (1) Is regular use of investigated product beneficial for improving serum vitamin D levels in elderly population? (2) Is regular use of investigated product beneficial for increasing daily protein intake in elderly population? (3) Is regular use of investigated product beneficial for improving vitamin B12 status in elderly population?
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Subjects will be randomized on the first day of Visit 1 using simple randomisation using ratio 1:1 between test and placebo group.
After the general subject's health is checked (vital signs), subjects will be assigned Subject Number, which will be pre-randomised to correspond with one of interventions (test group, placebo group).
To assure double blind approach, study products will be packed in neutral packaging, and pre-labelled with Subject Number (S-XXX) and instructions for use. Selected site will be provided enough product i.e. subject boxes with corresponding Subject Number to cover initially planned number of included subject.
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject Informed consent form (ICF) is singed
- •Aged at least 65 at the time of the signature of ICF
- •A body mass index lower than 32 kg/m2
- •Willing to avoid a consumption supplementation with protein, vitamin D and vitamin B12 during the study
- •Willing to follow all study procedures, including attending all site visits (including blood sampling) and keeping a diary for using the product and six 24-hour dietary records (3x pre-intervention, 3x during last week of the intervention)
排除标准
- •Medical treatment with Vitamin D and/or Vitamin B12
- •Supplementation with protein, vitamin D and/or vitamin B12 during least 2 months
- •Known drug and/or alcohol abuse
- •Known lactose/gluten intolerances/food allergies
- •Inadequate veins (in the opinion of the investigator) or known contraindication for venous blood withdrawal
- •Have chronic bowel disease (ulcerative colitis, Chron's disease, stomach or duodenal ulcer, chronic inflammation of the stomach or duodenum)
- •Have acute gastrointestinal infection with vomiting and / or diarrhea
- •Have planned general anaesthesia or colonoscopy at the time of the study
- •Have malabsorption syndrome
- •Less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)
- •Have stomach or bowel resection
- •Do not have neat and functional teeth
- •Take regular or occasional laxative products
- •Use antacids (Rupurut / Rutacid / Talcit)
- •Mental incapacity that precludes adequate understanding or cooperation
- •Participation in another investigational study
结局指标
主要结局
Change in serum vitamin D levels will be determined
时间窗: 56 days
Serum level of 25-OH-vitamin D will be measured before and after the intervention for each individual.
次要结局
- Change in dietary protein intake will be determined(56 days)
- Malnutrition at baseline(baseline)
- Change in serum vitamin B12 levels will be determined(56 days)