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The main aim of this clinical trial is to learn if a nutritional supplement improves health status from a nutritional point of view in an active and healthy elderly population. It will also study about the improvement of anthropometric variables, vitality, quality of life and mood, as well as biochemical and metabolic changes produced after the intervention.
The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Supplement | Experimental | 1 sachet of nutritional supplement (30g) in the morning and 1 sachet (30g) in the afternoon during 8 weeks. A total of 60g daily. |
|
| Control | Placebo Comparator | 1 sachet of placebo supplement (30g) in the morning and 1 sachet (30g) in the afternoon during 8 weeks. A total of 60g daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional supplement | Dietary Supplement | 60g of a nutritional supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional score. | A nutritional score was created ad hoc to estimate the effects of a nutritional supplement . The parameters included in the score were: muscle mass, lymphocyte level, protein status, vitamin D, folic acid, vitamin B12, calcium, iron, zinc, and homocysteine levels | Days 0 and 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary intake | Analysis of dietary intake (types of food and energy and nutritional value of the diet), using a food frequency questionnaire | Days 0 and 56 |
| Height | Height will be measured by stadiometer and reported in m. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Navarra | Pamplona | Navarre | 31008 | Spain |
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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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A randomized, parallel, double-blind, 8-week nutritional intervention trial
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| Control supplement | Dietary Supplement | 60g of a placebo supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon |
|
| Days 0 and 56 |
| Weight | Weight will be measured by bioimpedance and reported in kg. | Days 0 and 56 |
| Waist circumference | Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters. | Days 0 and 56 |
| Hip circumference | Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters. | Days 0 and 56 |
| Total adipose tissue | Total adipose tissue will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance | Days 0 and 56 |
| Visceral adipose tissue | Visceral adipose tissue will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance | Days 0 and 56 |
| Lean mass | Lean mass will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance | Days 0 and 56 |
| Upper limb strength | Upper limb strength will be measured in the bench press exercise | Days 0 and 56 |
| Lower limb strength | Lower limb strength will be measured using the sit-and-stand test in 30 seconds | Days 0 and 56 |
| Maximum hand grip | Maximum hand grip will be measured using a manual dynamometer | Days 0 and 56 |
| Blood fasting glucose | Blood will be extracted at fasting state and glucose levels will be determined by autoanalyzer Pentra-C200. | Days 0 and 56 |
| Blood fasting insulin | Blood will be extracted at fasting state and insulin levels will be determined by ELISA. | Days 0 and 56 |
| Total cholesterol | Blood will be extracted at fasting state and Total cholesterol levels of participants will be analysed by autoanalyzer Pentra-C200. | Days 0 and 56 |
| HDL-cholesterol | Blood will be extracted at fasting state and HDL cholesterol levels of participants will be analysed by autoanalyzer Pentra-C200. | Days 0 and 56 |
| LDL-cholesterol | LDL cholesterol levels of participants will be calculated by Friedewald equation. | Days 0 and 56 |
| Triglycerides | Blood will be extracted at fasting state and triglyceride levels of participants will be analysed by autoanalyzer Pentra-C200. | Days 0 and 56 |
| C-Reactive Protein | C-Reactive Protein will be measured in an automated ELISA processing system | Days 0 and 56 |
| Interleukin 6 | Interleukin 6 will be measured in an automated ELISA processing system | Days 0 and 56 |
| Tumor necrosis factor -α | Tumor necrosis factor -α will be measured in an automated ELISA processing system | Days 0 and 56 |
| Blood pressure | Systolic and Diastolic blood pressure in fasting condition will be analyzed by electronic tensiometer and reported in mmHg. | Days 0 and 56 |
| Depression level | Depression level will be measured by the validated Spanish translation of the Beck Depression Inventory (BDI) | Days 0 and 56 |
| Anxiety level | Anxiety level will be measured by by the validated Spanish translation of the State-Trait Anxiety Inventory (STAI) | Days 0 and 56 |
| Short Form-36 questionnaire | Quality of life is measure by the Short Form -36, a questionnaire with eight scales physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitations and general health perception | Days 0 and 56 |