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

NCT ID: NCT05527249

Last Updated: 2022-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-24
• Study Completion Date: 2022-02-22

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.

Conditions

Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary Supplement

Intervention Type: DIETARY_SUPPLEMENT

20g of protein powder + 650mg of pomegranate extracts

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.

Group Type: PLACEBO_COMPARATOR

Placebo of the dietary supplement

Intervention Type: OTHER

20g of protein powder + 650mg of maltodextrin

Interventions

Dietary Supplement

20g of protein powder + 650mg of pomegranate extracts

Intervention Type: DIETARY_SUPPLEMENT

Placebo of the dietary supplement

20g of protein powder + 650mg of maltodextrin

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise Deldicque

Role: STUDY_DIRECTOR

Université Catholique de Louvain

Locations

UCLouvain - CICN

Louvain-la-Neuve, , Belgium

Countries

Belgium

Other Identifiers

Delicens2021

Identifier Type: -

Identifier Source: org_study_id