Study of a Nutritional Supplement for Healthy Aging

Not Applicable

Completed

• Conditions: Nutrition, Healthy; Quality of Life

• Registration Number: NCT06743841
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-04-04
• Study Completion: 2022-09-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Waist circumference	Days 0 and 56	Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
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.
Blood fasting insulin	Days 0 and 56	Blood will be extracted at fasting state and insulin levels will be determined by ELISA.
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.
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

Trial Locations

Locations (1)

University of Navarra; 🇪🇸 Pamplona, Navarra, Spain