Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2021-09-01
2022-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Nutritional supplement
60g of a nutritional supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon
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.
Control supplement
60g of a placebo supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nutritional supplement
60g of a nutritional supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon
Control supplement
60g of a placebo supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
65 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Navarra
Pamplona, Navarre, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACTIPRO SENIOR (2021.116)
Identifier Type: -
Identifier Source: org_study_id