Study of a Nutritional Supplement for Healthy Aging (ACTIPRO SENIOR)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Nutrition, Healthy
• Intervention / Treatment: Dietary supplement: Nutritional supplement; Dietary supplement: Control supplement

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • University of Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional Supplement; 1 sachet of nutritional supplement (30g) in the morning and 1 sachet (30g) in the afternoon during 8 weeks. A total of 60g daily.	Dietary supplement: Nutritional supplement; 60g of a nutritional supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon
Placebo Comparator: Control; 1 sachet of placebo supplement (30g) in the morning and 1 sachet (30g) in the afternoon during 8 weeks. A total of 60g daily.	Dietary supplement: Control supplement; 60g of a placebo supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): April 4, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Nutritional status; Healthy aging; Nutritional supplement
• Other Study ID Numbers: ACTIPRO SENIOR (2021.116)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No