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Completed

NCT Number: NCT06743841

Study of a Nutritional Supplement for Healthy Aging

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.

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Key information

Conditions

Nutrition, Healthy Quality of Life

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Navarra

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional Supplement

Dietary Supplement

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

Control supplement

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Dietary intake

    Time frame: Days 0 and 56

    Analysis of dietary intake (types of food and energy and nutritional value of the diet), using a food frequency questionnaire

  2. Height

    Time frame: Days 0 and 56

    Height will be measured by stadiometer and reported in m.

  3. Weight

    Time frame: Days 0 and 56

    Weight will be measured by bioimpedance and reported in kg.

  4. Waist circumference

    Time frame: Days 0 and 56

    Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.

  5. Hip circumference

    Time frame: Days 0 and 56

    Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.

  6. Total adipose tissue

    Time frame: Days 0 and 56

    Total adipose tissue will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance

  7. Visceral adipose tissue

    Time frame: Days 0 and 56

    Visceral adipose tissue will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance

  8. Lean mass

    Time frame: Days 0 and 56

    Lean mass will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance

  9. Upper limb strength

    Time frame: Days 0 and 56

    Upper limb strength will be measured in the bench press exercise

  10. Lower limb strength

    Time frame: Days 0 and 56

    Lower limb strength will be measured using the sit-and-stand test in 30 seconds

  11. Maximum hand grip

    Time frame: Days 0 and 56

    Maximum hand grip will be measured using a manual dynamometer

  12. Blood fasting glucose

    Time frame: Days 0 and 56

    Blood will be extracted at fasting state and glucose levels will be determined by autoanalyzer Pentra-C200.

  13. Blood fasting insulin

    Time frame: Days 0 and 56

    Blood will be extracted at fasting state and insulin levels will be determined by ELISA.

  14. Total cholesterol

    Time frame: Days 0 and 56

    Blood will be extracted at fasting state and Total cholesterol levels of participants will be analysed by autoanalyzer Pentra-C200.

  15. HDL-cholesterol

    Time frame: Days 0 and 56

    Blood will be extracted at fasting state and HDL cholesterol levels of participants will be analysed by autoanalyzer Pentra-C200.

  16. LDL-cholesterol

    Time frame: Days 0 and 56

    LDL cholesterol levels of participants will be calculated by Friedewald equation.

  17. Triglycerides

    Time frame: Days 0 and 56

    Blood will be extracted at fasting state and triglyceride levels of participants will be analysed by autoanalyzer Pentra-C200.

  18. C-Reactive Protein

    Time frame: Days 0 and 56

    C-Reactive Protein will be measured in an automated ELISA processing system

  19. Interleukin 6

    Time frame: Days 0 and 56

    Interleukin 6 will be measured in an automated ELISA processing system

  20. Tumor necrosis factor -α

    Time frame: Days 0 and 56

    Tumor necrosis factor -α will be measured in an automated ELISA processing system

  21. Blood pressure

    Time frame: Days 0 and 56

    Systolic and Diastolic blood pressure in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.

  22. Depression level

    Time frame: Days 0 and 56

    Depression level will be measured by the validated Spanish translation of the Beck Depression Inventory (BDI)

  23. Anxiety level

    Time frame: Days 0 and 56

    Anxiety level will be measured by by the validated Spanish translation of the State-Trait Anxiety Inventory (STAI)

  24. Short Form-36 questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

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

Acronym: ACTIPRO SENIOR

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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