Study of a Nutritional Supplement for Healthy Aging

NCT06743841 | Completed

• 1 other identifier: ACTIPRO SENIOR (2021.116)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition, Healthy; Quality of Life

Keywords

Healthy aging; Nutritional status; Nutritional supplement; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Dietary intake

  Days 0 and 56

• Height

  Days 0 and 56

• Weight

  Days 0 and 56

• Waist circumference

  Days 0 and 56

• Hip circumference

  Days 0 and 56

Study Arms (2)

Nutritional Supplement

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Nutritional supplement DIETARY_SUPPLEMENT

60g of a nutritional supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon

Nutritional Supplement

Control supplement DIETARY_SUPPLEMENT

60g of a placebo supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon

Control

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

University of Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, parallel, double-blind, 8-week nutritional intervention trial

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: September 1, 2021
• Primary Completion: April 4, 2022
• Study Completion: September 30, 2022
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

ES (1)