Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People

Conditions
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Healthy Aging

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement
* Other: Placebo of the dietary supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement group<br>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. | Dietary Supplement: Dietary Supplement<br>* 20g of protein powder + 650mg of pomegranate extracts<br>|
| Placebo Comparator: Placebo group<br>20g of protein powder + 1 tablet of maltodextrin / day for 21 days of the dietary supplement, to be taken every day before lunch time. | Other: Placebo of the dietary supplement<br>* 20g of protein powder + 650mg of maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of white blood cells (10^3/μL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of red blood cells (10^6/μL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of hemoglobin level (g/dL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Evolution from baseline of hematocrit level (%) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Evolution from baseline of platelet count (10^3/μL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of Uric acid (mg/dL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of creatinine (mg/dL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of total bilirubin (mg/dL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of aspartate transaminase (U/L) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of alanine transaminase (U/L) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of total cholesterol (mg/dL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of triglyceride levels (mg/dL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of sodium (mmol/L) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of potassium (mmol/L) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of proteins (g/L) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of prealbumin (g/L) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of urea (mg/dL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of blood sugar (mg/dL) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of alkalin phosphatase (U/L) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of GGT (U/L) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of LDH (U/L) at 3 weeks | Comparison within and between groups after 3 weeks of intervention. | 21 days | 
| Change from baseline of CRP (mg/L) at 3 weeks | Comparison within and between groups after 3 weeks of completion. | 21 days | 
| Change from baseline of weight (kg) at 3 weeks | Comparison within and between groups after 3 weeks of completion. | 21 days | 
| Change from baseline of heart rate (bpm) at 3 weeks | Comparison within and between groups after 3 weeks of completion. | 21 days | 
| Change from baseline of systolic blood pressure at 3 weeks | Comparison within and between groups after 3 weeks of completion. | 21 days | 
| Change from baseline of diastolic blood pressure at 3 weeks | Comparison within and between groups after 3 weeks of completion. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse events | Number of adverse events | 21 days | 
| Type of Adverse events | Type of adverse events | 21 days | 
| Number of Concomitant drug use | Number of concomitant drugs | 21 days | 
| Type of Concomitant drug use | Type of concomitant drugs | 21 days | 
| Compliance with therapeutic units | Counting of therapeutic units | 21 days | 
| Compliance with protein and/or grenade powder | Counting of amount of powder | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, pomegranate extracts, protein, older people