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

Healthy Aging Clinical Trial

— Delicens2021  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527249
• Other study ID #: Delicens2021
• Status: Completed
• Phase: N/A
• Start date: December 24, 2021
• Est. completion date: February 22, 2022

Study information

• Verified date: September 2022
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Dietary Supplement:
• Dietary Supplement
20g of protein powder + 650mg of pomegranate extracts

Other:
• Placebo of the dietary supplement
20g of protein powder + 650mg of maltodextrin

Locations

Country	Name	City	State
Belgium	UCLouvain - CICN	Louvain-La-Neuve

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change from baseline of hemoglobin level (g/dL) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Evolution from baseline of hematocrit level (%) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Evolution from baseline of platelet count (10^3/µL) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of Uric acid (mg/dL) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of creatinine (mg/dL) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of total bilirubin (mg/dL) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of aspartate transaminase (U/L) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of alanine transaminase (U/L) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of total cholesterol (mg/dL) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of triglyceride levels (mg/dL) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of sodium (mmol/L) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of potassium (mmol/L) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of proteins (g/L) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of prealbumin (g/L) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of urea (mg/dL) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of blood sugar (mg/dL) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of alkalin phosphatase (U/L) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of GGT (U/L) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of LDH (U/L) at 3 weeks	Comparison within and between groups after 3 weeks of intervention.	21 days
Primary	Change from baseline of CRP (mg/L) at 3 weeks	Comparison within and between groups after 3 weeks of completion.	21 days
Primary	Change from baseline of weight (kg) at 3 weeks	Comparison within and between groups after 3 weeks of completion.	21 days
Primary	Change from baseline of heart rate (bpm) at 3 weeks	Comparison within and between groups after 3 weeks of completion.	21 days
Primary	Change from baseline of systolic blood pressure at 3 weeks	Comparison within and between groups after 3 weeks of completion.	21 days
Primary	Change from baseline of diastolic blood pressure at 3 weeks	Comparison within and between groups after 3 weeks of completion.	21 days
Secondary	Number of Adverse events	Number of adverse events	21 days
Secondary	Type of Adverse events	Type of adverse events	21 days
Secondary	Number of Concomitant drug use	Number of concomitant drugs	21 days
Secondary	Type of Concomitant drug use	Type of concomitant drugs	21 days
Secondary	Compliance with therapeutic units	Counting of therapeutic units	21 days
Secondary	Compliance with protein and/or grenade powder	Counting of amount of powder	21 days