Study of the Efficacy of a New Nutritional Supplement, Compared with Placebo, in Promoting Active and Healthy Aging from the Age of 65

Clinica Universidad de Navarra, Universidad de Navarra1 site in 1 country60 target enrollmentSeptember 1, 2021

ConditionsNutrition, Healthy Quality of Life

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nutrition, Healthy
Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Enrollment: 60
Locations: 1
Primary Endpoint: Nutritional score.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2021

End Date

September 30, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women between 65 and 80 years of age, inclusive.
•Body mass index (BMI) less than 35 kg/m
•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).

Outcomes

Primary Outcomes

Nutritional score.

Time Frame: 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