Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evolution from baseline of platelet count (10^3/μL) at 3 weeks
研究概览
简要总结
The objective of this safety study is to evaluate the safety of a combination of proteins and pomegranate extracts in healthy subjects aged 65 years or more after 21 days of supplementation.
详细描述
The aim of the Delicen's project is to find an effective solution to avoid undernutrition in the elderly by proposing an assortment of food products for people who are undernourished or at risk of undernutrition. These products will be enriched with proteins and pomegranate extracts. Before to realize the impact study to test products enriched with proteins and pomegranate extracts, a safety study will be carried out.
The objective of this safety study (double-blind randomized clinical trial) is to evaluate the safety of a combination of proteins and pomegranate extracts in healthy subjects aged 65 years or more in comparing a control group consuming 20g of proteins (100% of lactoserum proteins) and 650mg of maltodextrin to a test group consuming 20g of proteins (100% of lactoserum proteins) and 650mg of pomegranate extracts after 21 days of supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Woman and man, aged ≥ 65 years;
- •BMI from 20 to 30 and from 21 to 30 for a person aged >70 years;
- •In good general health as evidenced by medical history and physical examination;
- •Provision of signed and dated informed consent form;
- •Stated willingness to comply with all study procedures and availability for the duration of the study;
- •Fluent French speaking.
排除标准
- •Severe psychiatric disorder or disease within 6 months before inclusion (depression, bipolar disorder, severe anxiety, psychosis, schizophrenic disorders, dementia...) or severe neurologic trouble (Alzheimer's, autism, Parkinson's disease, ...);
- •Cancer within less than 3 years before the screening visit (except basal cell skin cancer or squamous cell skin cancer), which in the Investigator's opinion could interfere with the results of the study;
- •Subjects presenting severe gastro-intestinal, severe hepatic, severe respiratory, severe kidney or severe cardiovascular disorder or severe infection (e.g., HIV, hepatitis, ...);
- •Uncontrolled hormonal disorders (example: thyroid problems or Cushing's syndrome);
- •Uncontrolled type 1 or 2 diabetes;
- •Any clinically significant disease which in the Investigator's opinion could interfere with the safety of study participants or with the results of the study;
- •Allergy or intolerance to one of the components of the administered products;
- •Subjects with medications/products incompatible with the study according to the investigator (i.e: medications that could interfere with nutrient absorption);
- •Subjects having participated in another clinical trial (with an investigational product) one month before the screening;
- •Mental or legal incapacity, unwillingness or inability to understand or not being able to participate in the study;
- •Subjects consuming ONS or protein supplements one month before the screening.
结局指标
主要结局
Evolution from baseline of platelet count (10^3/μL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of total cholesterol (mg/dL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of proteins (g/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of white blood cells (10^3/μL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of red blood cells (10^6/μL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of hemoglobin level (g/dL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Evolution from baseline of hematocrit level (%) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of Uric acid (mg/dL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of total bilirubin (mg/dL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of aspartate transaminase (U/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of sodium (mmol/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of GGT (U/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of LDH (U/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of weight (kg) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of completion.
Change from baseline of alanine transaminase (U/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of triglyceride levels (mg/dL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of potassium (mmol/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of prealbumin (g/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of urea (mg/dL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of creatinine (mg/dL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of blood sugar (mg/dL) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of alkalin phosphatase (U/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of CRP (mg/L) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of completion.
Change from baseline of systolic blood pressure at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of completion.
Change from baseline of diastolic blood pressure at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of completion.
Change from baseline of heart rate (bpm) at 3 weeks
时间窗: 21 days
Comparison within and between groups after 3 weeks of completion.
次要结局
- Number of Adverse events(21 days)
- Type of Adverse events(21 days)
- Number of Concomitant drug use(21 days)
- Type of Concomitant drug use(21 days)
- Compliance with therapeutic units(21 days)
- Compliance with protein and/or grenade powder(21 days)