Clinical trial NCT06743841: Study of a Nutritional Supplement for Healthy Aging
Official title: Study of the Efficacy of a New Nutritional Supplement, Compared with Placebo, in Promoting Active and Healthy Aging from the Age of 65
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Quality of Life
Keywords: Healthy aging
Nutritional status
Nutritional supplement
Quality of life
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, parallel, double-blind, 8-week nutritional intervention trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Nutritional score.
timeFrame: Days 0 and 56
Secondary outcomes:
measure: Dietary intake
timeFrame: Days 0 and 56
measure: Height
timeFrame: Days 0 and 56
measure: Weight
timeFrame: Days 0 and 56
measure: Waist circumference
timeFrame: Days 0 and 56
measure: Hip circumference
timeFrame: Days 0 and 56
measure: Total adipose tissue
timeFrame: Days 0 and 56
measure: Visceral adipose tissue
timeFrame: Days 0 and 56
measure: Lean mass
timeFrame: Days 0 and 56
measure: Upper limb strength
timeFrame: Days 0 and 56
measure: Lower limb strength
timeFrame: Days 0 and 56
measure: Maximum hand grip
timeFrame: Days 0 and 56
measure: Blood fasting glucose
timeFrame: Days 0 and 56
measure: Blood fasting insulin
timeFrame: Days 0 and 56
measure: Total cholesterol
timeFrame: Days 0 and 56
measure: HDL-cholesterol
timeFrame: Days 0 and 56
measure: LDL-cholesterol
timeFrame: Days 0 and 56
measure: Triglycerides
timeFrame: Days 0 and 56
measure: C-Reactive Protein
timeFrame: Days 0 and 56
measure: Interleukin 6
timeFrame: Days 0 and 56
measure: Tumor necrosis factor -α
timeFrame: Days 0 and 56
measure: Blood pressure
timeFrame: Days 0 and 56
measure: Depression level
timeFrame: Days 0 and 56
measure: Anxiety level
timeFrame: Days 0 and 56
measure: Short Form-36 questionnaire
timeFrame: Days 0 and 56
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: University of Navarra
state: Navarra
Study officials:
References: