Evaluation of a Dietary Supplementation Combining Proteins and Pomegranate Extracts in Older People
Delicens2021
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2022
CompletedFirst Submitted
Initial submission to the registry
August 29, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedSeptember 2, 2022
September 1, 2022
2 months
August 29, 2022
September 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (26)
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 Outcomes (6)
Number of Adverse events
21 days
Type of Adverse events
21 days
Number of Concomitant drug use
21 days
Type of Concomitant drug use
21 days
Compliance with therapeutic units
21 days
- +1 more secondary outcomes
Study Arms (2)
Dietary supplement group
EXPERIMENTAL20g 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 COMPARATOR20g of protein powder + 1 tablet of maltodextrin / day for 21 days of the dietary supplement, to be taken every day before lunch time.
Interventions
20g of protein powder + 650mg of pomegranate extracts
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLouvain - CICN
Louvain-la-Neuve, 1348, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Louise Deldicque
Université Catholique de Louvain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2022
First Posted
September 2, 2022
Study Start
December 24, 2021
Primary Completion
February 22, 2022
Study Completion
February 22, 2022
Last Updated
September 2, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share