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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement | Dietary Supplement | 20g of protein powder + 650mg of pomegranate extracts |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse events | Number of adverse events | 21 days |
| Type of Adverse events | Type of adverse events | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise Deldicque | Université Catholique de Louvain | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLouvain - CICN | Louvain-la-Neuve | 1348 | Belgium |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo of the dietary supplement | Other | 20g of protein powder + 650mg of maltodextrin |
|
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 |
| 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 |