Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People
- Conditions
- Healthy Aging
- Interventions
- Dietary Supplement: Dietary SupplementOther: Placebo of the dietary supplement
- Registration Number
- NCT05527249
- Lead Sponsor
- Université Catholique de Louvain
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dietary supplement group Dietary Supplement 20g of protein powder + 1 tablet of pomegranate extracts / day for 21 days of the dietary supplement, to be taken every day before lunch time. Placebo group Placebo of the dietary supplement 20g of protein powder + 1 tablet of maltodextrin / day for 21 days of the dietary supplement, to be taken every day before lunch time.
- Primary Outcome Measures
Name Time Method Evolution from baseline of platelet count (10^3/μL) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of total cholesterol (mg/dL) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of proteins (g/L) at 3 weeks 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 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 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of hemoglobin level (g/dL) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Evolution from baseline of hematocrit level (%) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of Uric acid (mg/dL) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of total bilirubin (mg/dL) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of aspartate transaminase (U/L) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of sodium (mmol/L) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of GGT (U/L) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of LDH (U/L) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of weight (kg) at 3 weeks 21 days Comparison within and between groups after 3 weeks of completion.
Change from baseline of alanine transaminase (U/L) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of triglyceride levels (mg/dL) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of potassium (mmol/L) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of prealbumin (g/L) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of urea (mg/dL) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of creatinine (mg/dL) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of blood sugar (mg/dL) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of alkalin phosphatase (U/L) at 3 weeks 21 days Comparison within and between groups after 3 weeks of intervention.
Change from baseline of CRP (mg/L) at 3 weeks 21 days Comparison within and between groups after 3 weeks of completion.
Change from baseline of systolic blood pressure at 3 weeks 21 days Comparison within and between groups after 3 weeks of completion.
Change from baseline of diastolic blood pressure at 3 weeks 21 days Comparison within and between groups after 3 weeks of completion.
Change from baseline of heart rate (bpm) at 3 weeks 21 days Comparison within and between groups after 3 weeks of completion.
- Secondary Outcome Measures
Name Time Method Number of Adverse events 21 days Number of adverse events
Type of Adverse events 21 days Type of adverse events
Number of Concomitant drug use 21 days Number of concomitant drugs
Type of Concomitant drug use 21 days Type of concomitant drugs
Compliance with therapeutic units 21 days Counting of therapeutic units
Compliance with protein and/or grenade powder 21 days Counting of amount of powder
Trial Locations
- Locations (1)
UCLouvain - CICN
🇧🇪Louvain-La-Neuve, Belgium