Healthy AgingDelicens2021NCT05527249
Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People
A study testing Dietary Supplement in people with Healthy Aging, run by Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Dec 2021to 22 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Dietary Supplement, Placebo of the dietary supplement
- Keywords
- safety, pomegranate extracts, protein, older people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementDietary supplement
20g of protein powder + 650mg of pomegranate extracts
Placebo of the dietary supplementOther
20g of protein powder + 650mg of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement group | Experimental | 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. Receives: Dietary Supplement: Dietary Supplement |
| Placebo group | Placebo comparator | 20g of protein powder + 1 tablet of maltodextrin / day for 21 days of the dietary supplement, to be taken every day before lunch time. Receives: Other: Placebo of the dietary supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of white blood cells (10^3/μL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 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.
Measured: 21 days
Change from baseline of hemoglobin level (g/dL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Evolution from baseline of hematocrit level (%) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Evolution from baseline of platelet count (10^3/μL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of Uric acid (mg/dL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of creatinine (mg/dL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of total bilirubin (mg/dL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of aspartate transaminase (U/L) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of alanine transaminase (U/L) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of total cholesterol (mg/dL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of triglyceride levels (mg/dL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of sodium (mmol/L) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of potassium (mmol/L) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of proteins (g/L) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of prealbumin (g/L) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of urea (mg/dL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of blood sugar (mg/dL) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of alkalin phosphatase (U/L) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of GGT (U/L) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of LDH (U/L) at 3 weeks
Comparison within and between groups after 3 weeks of intervention.
Measured: 21 days
Change from baseline of CRP (mg/L) at 3 weeks
Comparison within and between groups after 3 weeks of completion.
Measured: 21 days
Change from baseline of weight (kg) at 3 weeks
Comparison within and between groups after 3 weeks of completion.
Measured: 21 days
Change from baseline of heart rate (bpm) at 3 weeks
Comparison within and between groups after 3 weeks of completion.
Measured: 21 days
Change from baseline of systolic blood pressure at 3 weeks
Comparison within and between groups after 3 weeks of completion.
Measured: 21 days
Change from baseline of diastolic blood pressure at 3 weeks
Comparison within and between groups after 3 weeks of completion.
Measured: 21 days
Secondary outcomes (6)
Number of Adverse events
Number of adverse events
Measured: 21 days
Type of Adverse events
Type of adverse events
Measured: 21 days
Number of Concomitant drug use
Number of concomitant drugs
Measured: 21 days
Type of Concomitant drug use
Type of concomitant drugs
Measured: 21 days
Compliance with therapeutic units
Counting of therapeutic units
Measured: 21 days
Compliance with protein and/or grenade powder
Counting of amount of powder
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start24 Dec 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Deldicque, Study director, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527249
- Sponsor's protocol ID
- Delicens2021
- Acronym
- Delicens2021
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People
- ClinicalTrials.gov ID
- NCT05527249
- Acronym / sponsor ID
- Delicens2021 / Delicens2021
- Conditions
- Healthy Aging
- Keywords
- safety, pomegranate extracts, protein, older people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 24 Dec 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement group | Experimental | Dietary Supplement: Dietary Supplement20g of protein powder + 1 tablet of pomegranate extracts / day for 21 days of the dietary supplement, to be taken every day before lunch time. |
| Placebo group | Placebo comparator | Other: Placebo of the dietary supplement20g of protein powder + 1 tablet of maltodextrin / day for 21 days of the dietary supplement, to be taken every day before lunch time. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement20g of protein powder + 650mg of pomegranate extracts | Dietary supplement | Dietary supplement group |
| Placebo of the dietary supplement20g of protein powder + 650mg of maltodextrin | Other | Placebo group |
Primary outcome
Change from baseline of white blood cells (10^3/μL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of red blood cells (10^6/μL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of hemoglobin level (g/dL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Evolution from baseline of hematocrit level (%) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Evolution from baseline of platelet count (10^3/μL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of Uric acid (mg/dL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of creatinine (mg/dL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of total bilirubin (mg/dL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of aspartate transaminase (U/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of alanine transaminase (U/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of total cholesterol (mg/dL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of triglyceride levels (mg/dL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of sodium (mmol/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of potassium (mmol/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of proteins (g/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of prealbumin (g/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of urea (mg/dL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of blood sugar (mg/dL) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of alkalin phosphatase (U/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of GGT (U/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of LDH (U/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of intervention.
Change from baseline of CRP (mg/L) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of completion.
Change from baseline of weight (kg) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of completion.
Change from baseline of heart rate (bpm) at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of completion.
Change from baseline of systolic blood pressure at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of completion.
Change from baseline of diastolic blood pressure at 3 weeks
Time frame: 21 days
Comparison within and between groups after 3 weeks of completion.
6 secondary outcomes
Number of Adverse events
Time frame: 21 days
Type of Adverse events
Time frame: 21 days
Number of Concomitant drug use
Time frame: 21 days
Type of Concomitant drug use
Time frame: 21 days
Compliance with therapeutic units
Time frame: 21 days
Compliance with protein and/or grenade powder
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Deldicque study director
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement in people with Healthy Aging, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of white blood cells (10^3/μL) at 3 weeks (time frame: 21 days). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.