Clinical trial NCT05527249: Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People
Official title: Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Keywords: safety
pomegranate extracts
protein
older people
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of white blood cells (10^3/μL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of red blood cells (10^6/μL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of hemoglobin level (g/dL) at 3 weeks
timeFrame: 21 days
measure: Evolution from baseline of hematocrit level (%) at 3 weeks
timeFrame: 21 days
measure: Evolution from baseline of platelet count (10^3/μL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of Uric acid (mg/dL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of creatinine (mg/dL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of total bilirubin (mg/dL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of aspartate transaminase (U/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of alanine transaminase (U/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of total cholesterol (mg/dL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of triglyceride levels (mg/dL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of sodium (mmol/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of potassium (mmol/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of proteins (g/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of prealbumin (g/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of urea (mg/dL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of blood sugar (mg/dL) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of alkalin phosphatase (U/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of GGT (U/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of LDH (U/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of CRP (mg/L) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of weight (kg) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of heart rate (bpm) at 3 weeks
timeFrame: 21 days
measure: Change from baseline of systolic blood pressure at 3 weeks
timeFrame: 21 days
measure: Change from baseline of diastolic blood pressure at 3 weeks
timeFrame: 21 days
Secondary outcomes:
measure: Number of Adverse events
timeFrame: 21 days
measure: Type of Adverse events
timeFrame: 21 days
measure: Number of Concomitant drug use
timeFrame: 21 days
measure: Type of Concomitant drug use
timeFrame: 21 days
measure: Compliance with therapeutic units
timeFrame: 21 days
measure: Compliance with protein and/or grenade powder
timeFrame: 21 days
Other outcomes:
Locations:
city: Louvain-La-Neuve
country: Belgium
facility: UCLouvain - CICN
Study officials:
affiliation: Université Catholique de Louvain
name: Louise Deldicque
role: STUDY_DIRECTOR
References: