Nutrition, Healthy, Quality of Life
Conditions
Keywords
Healthy aging, Nutritional status, Nutritional supplement, Quality of life
Brief summary
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: * Does a nutritional supplement improve the general nutritional status? * What health parameters improve most clearly after taking the supplement? Researchers will compare a nutritional supplement to a placebo (a look-alike substance that contains no interest nutrients) to see if the nutritional supplement works to improve health status from a nutritional point of view. Participants will: * Take a nutritional supplement or a placebo every day for 8 weeks. * Visit the clinic once every 4 weeks for checkups and tests * Keep a diary of their symptoms and the degree of adherence to taking the nutritional supplement.
Interventions
DIETARY_SUPPLEMENTNutritional supplement
60g of a nutritional supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon
DIETARY_SUPPLEMENTControl supplement
60g of a placebo supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
A randomized, parallel, double-blind, 8-week nutritional intervention trial
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women between 65 and 80 years of age, inclusive. * Body mass index (BMI) less than 35 kg/m2. * Subjects must have a cultural level, general physical and psychological conditions that allow the understanding, monitoring and development of the study. * Agree to voluntarily participate in the study and provide their informed consent in writing, complying with the procedures and requirements of the study.
Exclusion criteria
* People allergic to soy or lactose, as the supplement contains traces. * Severe diseases or relevant functional or structural abnormalities of the digestive system: inflammatory bowel disease. * Surgical interventions of the digestive system with permanent sequelae such as resections (gastroduodenostomy…) * Presenting any type of serious or chronic or systemic disease such as: infections that cause impairment of the general condition, cardiovascular diseases, cardiac arrhythmias, stroke, neoplasia, severe kidney disease, liver disease… * Recent fracture in the last 3 months (strength training). * Subjects who present some type of cognitive and/or psychological impediment, Alzheimer's, depressive pathology, etc. * Pharmacological treatment that affects the study variables recently prescribed, without a stable dose prescribed. * People with diabetes of any type. * Intake of any type of nutritional supplement that includes vitamin D, folic acid, vitamin B6, vitamin B12, calcium, iron, zinc or proteins, in the last 3 months. * Being on any type of special diet and/or high alcohol consumption (more than 14 units in women and 20 units in men per week). * Subjects in whom poor collaboration is expected or who, in the opinion of the researcher, have difficulties in following the procedures of the study. * Lack of commitment (in the opinion of the researcher) to the intervention, suspicion of non-compliance, or real difficulties in following the development of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional score. | Days 0 and 56 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary intake | Days 0 and 56 | Analysis of dietary intake (types of food and energy and nutritional value of the diet), using a food frequency questionnaire |
| Height | Days 0 and 56 | Height will be measured by stadiometer and reported in m. |
| Weight | Days 0 and 56 | Weight will be measured by bioimpedance and reported in kg. |
| Hip circumference | Days 0 and 56 | Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters. |
| Total adipose tissue | Days 0 and 56 | Total adipose tissue will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance |
| Visceral adipose tissue | Days 0 and 56 | Visceral adipose tissue will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance |
| Lean mass | Days 0 and 56 | Lean mass will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance |
| Upper limb strength | Days 0 and 56 | Upper limb strength will be measured in the bench press exercise |
| Lower limb strength | Days 0 and 56 | Lower limb strength will be measured using the sit-and-stand test in 30 seconds |
| Maximum hand grip | Days 0 and 56 | Maximum hand grip will be measured using a manual dynamometer |
| Blood fasting glucose | Days 0 and 56 | Blood will be extracted at fasting state and glucose levels will be determined by autoanalyzer Pentra-C200. |
| Waist circumference | Days 0 and 56 | Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters. |
| Total cholesterol | Days 0 and 56 | Blood will be extracted at fasting state and Total cholesterol levels of participants will be analysed by autoanalyzer Pentra-C200. |
| HDL-cholesterol | Days 0 and 56 | Blood will be extracted at fasting state and HDL cholesterol levels of participants will be analysed by autoanalyzer Pentra-C200. |
| LDL-cholesterol | Days 0 and 56 | LDL cholesterol levels of participants will be calculated by Friedewald equation. |
| Triglycerides | Days 0 and 56 | Blood will be extracted at fasting state and triglyceride levels of participants will be analysed by autoanalyzer Pentra-C200. |
| C-Reactive Protein | Days 0 and 56 | C-Reactive Protein will be measured in an automated ELISA processing system |
| Interleukin 6 | Days 0 and 56 | Interleukin 6 will be measured in an automated ELISA processing system |
| Tumor necrosis factor -α | Days 0 and 56 | Tumor necrosis factor -α will be measured in an automated ELISA processing system |
| Blood pressure | Days 0 and 56 | Systolic and Diastolic blood pressure in fasting condition will be analyzed by electronic tensiometer and reported in mmHg. |
| Depression level | Days 0 and 56 | Depression level will be measured by the validated Spanish translation of the Beck Depression Inventory (BDI) |
| Anxiety level | Days 0 and 56 | Anxiety level will be measured by by the validated Spanish translation of the State-Trait Anxiety Inventory (STAI) |
| Short Form-36 questionnaire | Days 0 and 56 | 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 |
| Blood fasting insulin | Days 0 and 56 | Blood will be extracted at fasting state and insulin levels will be determined by ELISA. |
Countries
Spain
Outcome results
None listed