Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People (Delicens2021)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging
• Intervention / Treatment: Dietary supplement: Dietary Supplement; Other: Placebo of the dietary supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Louvain-La-Neuve, Belgium, 1348
    • UCLouvain - CICN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary supplement group; 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; 20g of protein powder + 650mg of pomegranate extracts
Placebo Comparator: Placebo group; 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; 20g of protein powder + 650mg of maltodextrin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Study Director: Louise Deldicque, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2021
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: safety; protein; older people; pomegranate extracts
• Other Study ID Numbers: Delicens2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No