Nutrition, HealthyACTIPRO SENIORNCT06743841
Study of a Nutritional Supplement for Healthy Aging
A study testing Nutritional supplement in people with Nutrition, Healthy and Quality of Life, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Quality of Life
- What is being tested?
- Nutritional supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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
- Being tested
- Nutritional supplement, Control supplement
- Keywords
- Healthy aging, Nutritional status, Nutritional supplement, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional supplementDietary supplement
60g of a nutritional supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon
Control supplementDietary supplement
60g of a placebo supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Control supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 0 and 56
Secondary outcomes (24)
Dietary intake
Analysis of dietary intake (types of food and energy and nutritional value of the diet), using a food frequency questionnaire
Measured: Days 0 and 56
Height
Height will be measured by stadiometer and reported in m.
Measured: Days 0 and 56
Weight
Weight will be measured by bioimpedance and reported in kg.
Measured: Days 0 and 56
Waist circumference
Waist circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: Days 0 and 56
Hip circumference
Hip circumference of participants in fasting condition will be analyzed by measuring tape and reported in centimeters.
Measured: Days 0 and 56
Total adipose tissue
Total adipose tissue will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance
Measured: Days 0 and 56
Visceral adipose tissue
Visceral adipose tissue will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance
Measured: Days 0 and 56
Lean mass
Lean mass will be analyzed by dual-energy x-ray absorptiometry scan and electrical bioimpedance
Measured: Days 0 and 56
Upper limb strength
Upper limb strength will be measured in the bench press exercise
Measured: Days 0 and 56
Lower limb strength
Lower limb strength will be measured using the sit-and-stand test in 30 seconds
Measured: Days 0 and 56
Maximum hand grip
Maximum hand grip will be measured using a manual dynamometer
Measured: Days 0 and 56
Blood fasting glucose
Blood will be extracted at fasting state and glucose levels will be determined by autoanalyzer Pentra-C200.
Measured: Days 0 and 56
Blood fasting insulin
Blood will be extracted at fasting state and insulin levels will be determined by ELISA.
Measured: 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.
Measured: 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.
Measured: Days 0 and 56
LDL-cholesterol
LDL cholesterol levels of participants will be calculated by Friedewald equation.
Measured: Days 0 and 56
Triglycerides
Blood will be extracted at fasting state and triglyceride levels of participants will be analysed by autoanalyzer Pentra-C200.
Measured: Days 0 and 56
C-Reactive Protein
C-Reactive Protein will be measured in an automated ELISA processing system
Measured: Days 0 and 56
Interleukin 6
Interleukin 6 will be measured in an automated ELISA processing system
Measured: Days 0 and 56
Tumor necrosis factor -α
Tumor necrosis factor -α will be measured in an automated ELISA processing system
Measured: Days 0 and 56
Blood pressure
Systolic and Diastolic blood pressure in fasting condition will be analyzed by electronic tensiometer and reported in mmHg.
Measured: Days 0 and 56
Depression level
Depression level will be measured by the validated Spanish translation of the Beck Depression Inventory (BDI)
Measured: Days 0 and 56
Anxiety level
Anxiety level will be measured by by the validated Spanish translation of the State-Trait Anxiety Inventory (STAI)
Measured: 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
Measured: Days 0 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Sep 2021
- Primary completion4 Apr 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, parallel, double-blind, 8-week nutritional intervention trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743841
- Sponsor's protocol ID
- ACTIPRO SENIOR (2021.116)
- Acronym
- ACTIPRO SENIOR
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of a New Nutritional Supplement, Compared with Placebo, in Promoting Active and Healthy Aging from the Age of 65
- ClinicalTrials.gov ID
- NCT06743841
- Acronym / sponsor ID
- ACTIPRO SENIOR / ACTIPRO SENIOR (2021.116)
- Conditions
- Nutrition, Healthy, Quality of Life
- Keywords
- Healthy aging, Nutritional status, Nutritional supplement, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, parallel, double-blind, 8-week nutritional intervention trial
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement | Experimental | Dietary Supplement: Nutritional supplement1 sachet of nutritional supplement (30g) in the morning and 1 sachet (30g) in the afternoon during 8 weeks. A total of 60g daily. |
| Control | Placebo comparator | Dietary Supplement: Control supplement1 sachet of placebo supplement (30g) in the morning and 1 sachet (30g) in the afternoon during 8 weeks. A total of 60g daily. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional supplement60g of a nutritional supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon | Dietary supplement | Nutritional Supplement |
| Control supplement60g of a placebo supplement powder, divided into 2 daily intakes, one in the morning and one in the afternoon | Dietary supplement | Control |
Primary outcome
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
24 secondary outcomes
Dietary intake
Time frame: Days 0 and 56
Height
Time frame: Days 0 and 56
Weight
Time frame: Days 0 and 56
Waist circumference
Time frame: Days 0 and 56
Hip circumference
Time frame: Days 0 and 56
Total adipose tissue
Time frame: Days 0 and 56
Visceral adipose tissue
Time frame: Days 0 and 56
Lean mass
Time frame: Days 0 and 56
Upper limb strength
Time frame: Days 0 and 56
Lower limb strength
Time frame: Days 0 and 56
Maximum hand grip
Time frame: Days 0 and 56
Blood fasting glucose
Time frame: Days 0 and 56
Blood fasting insulin
Time frame: Days 0 and 56
Total cholesterol
Time frame: Days 0 and 56
HDL-cholesterol
Time frame: Days 0 and 56
LDL-cholesterol
Time frame: Days 0 and 56
Triglycerides
Time frame: Days 0 and 56
C-Reactive Protein
Time frame: Days 0 and 56
Interleukin 6
Time frame: Days 0 and 56
Tumor necrosis factor -α
Time frame: Days 0 and 56
Blood pressure
Time frame: Days 0 and 56
Depression level
Time frame: Days 0 and 56
Anxiety level
Time frame: Days 0 and 56
Short Form-36 questionnaire
Time frame: Days 0 and 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
Related trials for Nutrition, Healthy
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional supplement in people with Nutrition, Healthy and Quality of Life, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional score. (time frame: Days 0 and 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.