AgingSIPSENCT07456319
Sustainable Insect-based Protein Supplement in the Elderly: a Pilot Study
A study testing INSECT - Protein suplement based on edible insect flour in people with Aging and Nutrition, run by Universitat Oberta de Catalunya at 1 site in Spain.
Trial summary
This pilot randomized, double-blind, controlled trial evaluated the effects of a Tenebrio molitor-enriched protein biscuit combined with a structured physical activity program on cardiometabolic health in older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Nutrition, Sustainable Diets
- What is being tested?
- INSECT - Protein suplement based on edible insect flour
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 22 Dec 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Body mass index (BMI) between 18.5 and 30.0 kg/m²
- Mini-Mental State Examination (MMSE) score ≥ 16
- Independent in basic activities of daily living
- Mini Nutritional Assessment-Short Form (MNA-SF) score ≥ 8
- Ability to provide written informed consent
Who cannot join
- Food Neophobia Scale score > 4
- Chronic diseases affecting metabolism or nutritional status
- Dependency or severe functional impairment
- Current or past use of medications or supplements affecting body weight or metabolic function
- Excessive alcohol consumption
- History of eating disorders or psychiatric illness
- Known food allergies (e.g., crustacean allergy) or celiac disease
- Inability or unwillingness to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
This pilot randomized, double-blind, controlled trial evaluated the effects of a Tenebrio molitor-enriched protein biscuit combined with a structured physical activity program on cardiometabolic health in older adults. Participants aged 65 years and older were assigned to receive either insect-based or control biscuits following supervised exercise sessions for 28 days. Primary outcomes focused on changes in lipid profile, while secondary outcomes included anthropometric measures, body composition, blood pressure, physical function, glucose metabolism, hepatic function and inflammatory biomarkers.
Read the detailed description
Population aging and increasing environmental pressures on food systems underscore the need for sustainable dietary strategies that support healthy aging. Edible insects, such as Tenebrio molitor, provide high-quality protein with a substantially lower environmental footprint than conventional livestock and may represent a viable alternative protein source for older adults.
This pilot randomized, double-blind, parallel, controlled study was conducted in community-dwelling adults aged 60 years and older recruited from the Barcelona metropolitan area. Participants were randomly assigned to either an insect-based protein supplementation group or a control group. Both groups participated in an identical supervised physical activity program consisting of strength and resistance exercises performed three times per week over a 28-day intervention period.
The insect-based intervention consisted of three cookies per day, providing 35 g of Tenebrio molitor flour. Control cookies were wheat flour-based and matched for palatability and texture. Cookie consumption was supervised by a dietitian immediately after exercise sessions to ensure compliance. Participants were instructed to maintain their habitual diet and lifestyle throughout the study.
Primary outcomes included changes in conventional lipid profile parameters. Secondary outcomes comprised body weight, body composition, blood pressure, muscle strength and physical performance, glucose metabolism, hepatic enzymes, inflammatory biomarkers, advanced lipoprotein profiling, and plasma low-molecular-weight metabolites. Dietary intake was assessed using 3-day food records, and fasting blood samples were collected at baseline and post-intervention.
In addition, acceptability and organoleptic perception of the intervention products were evaluated using structured questionnaires, assessing taste, texture, appearance, and overall satisfaction. Gastrointestinal tolerance, including symptoms such as bloating, discomfort, and changes in bowel habits, was systematically recorded throughout the intervention. Participants' willingness to continue consuming the insect-based product after study completion was also assessed to explore feasibility and long-term adherence.
- Conditions
- Aging, Nutrition, Sustainable Diets, Cardiometabolic Health
- Being tested
- INSECT - Protein suplement based on edible insect flour, Control
- Keywords
- Feasibility trial, Edible insects, Tenebrio molitor, Older adults, Protein supplementation, Cardiometabolic health, Sustainable nutrition, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSECT - Protein suplement based on edible insect flourDietary supplement
Participants received a protein suplement in the form of cookies based on edible insect flour.
ControlDietary supplement
Control placebo
| Study group | Role | What they receive |
|---|---|---|
| INSECT | Experimental | Participants consumed three Tenebrio molitor-enriched cookies per day (35 g insect flour/day) immediately after supervised exercise sessions, three times per week for 28 days. Receives: Dietary Supplement: INSECT - Protein suplement based on edible insect flour |
| CONTROL | Placebo comparator | Participants consumed three wheat flour-based control cookies per day immediately after supervised exercise sessions, three times per week for 28 days. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Changes in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) and lipid particles (small, medium and large lipoproteins) Description: Changes in the lipid profile were assessed by measuring fasting plasma concentrations of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides at baseline and after the intervention. In addition, detailed lipoprotein particle profiling was performed to quantify the concentration and size distribution of lipoproteins, including small, medium, and large subclasses of LDL, HDL, and very-low-density lipoproteins (VLDL). These measures allowed evaluation of both conventional lipid parameters and qualitative changes in lipoprotein particle composition associated with the intervention.
Measured: One month (baseline and after the intervention)
Secondary outcomes (15)
Body Weight (Kg)
Body weight will be measured in kilograms (kg) using a calibrated digital scale, with participants wearing light clothing and no shoes. The change in body weight will be calculated as the difference between baseline and Day 28 measurements
Measured: Baseline to 28 days
Change in blood pressure (mmHg) .
Changes in systolic and diastolic blood pressure will be assessed to evaluate the cardiovascular response to the dietary intervention throughout the study period. Blood pressure will be measured in millimeters of mercury (mmHg) at baseline and at Day 28, using a calibrated sphygmomanometer. Changes from baseline to Day 28 will be calculated for both systolic and diastolic values.
Measured: Baseline to 28 days
Change in Handgrip Strength (kg)
Handgrip strength will be measured in kilograms (kg) using a calibrated handheld dynamometer under standardized conditions. The outcome will be expressed as the maximum value obtained from repeated trials of the dominant hand. The change in handgrip strength will be calculated as the difference between baseline and Day 28 measurements. Higher values indicate greater muscle strength.
Measured: Baseline to 28 days
Change in glucose (mg/dL).
Changes in fasting blood glucose will be measured in milligrams per deciliter (mg/dL) to determine changes in glycemic control associated with the dietary intervention. Blood glucose concentrations will be measured at baseline and at Day 28, and changes from baseline to Day 28 will be calculated.
Measured: Baseline to 28 days
Change in hepatic enzymes (ALT, AST, GGT)
Serum hepatic enzymes (ALT, AST, and GGT) will be analyzed as markers of liver function and to explore potential effects of the intervention on hepatic metabolic health.
Measured: Baseline to 28 days
Change in inflammatory biomarkers
Circulating inflammatory biomarkers will be measured to evaluate changes in systemic inflammation in response to the intervention
Measured: Baseline to 28 days
Change in plasma low molecular weight metabolite
Plasma low molecular weight metabolites will be analyzed using metabolomic approaches to characterize metabolic changes associated with the intervention.
Measured: Baseline to 28 days
Change in plasma and red blood cells fatty acids
Fatty acid composition in plasma and red blood cells will be assessed to evaluate changes in lipid metabolism and fatty acid status following the intervention.
Measured: Baseline to 28 days
Changes in Energy Intake (kcal/day)
Dietary intake will be assessed using 3-day food records collected at baseline and during the last week of the intervention. Mean daily energy intake will be calculated and expressed in kilocalories per day (kcal/day) using EasyDiet software. The change in energy intake will be calculated as the difference between baseline and Day 28 values.
Measured: Frame: Baseline to 28 days
Changes in Dietary Carbon Footprint (kg CO₂-eq/day)
Dietary carbon footprint (kg CO₂-equivalents/day) will be estimated by linking reported food intake to a validated life cycle assessment database (Poore \& Nemecek (via OWID) and WFLDB - World Food LCA Databas) Changes from baseline to the last week of intervention will be calculated.
Measured: Baseline to 28 days
Change in Body Mass Index (kg/m²)
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Height will be measured at baseline using a calibrated digital scale. Changes in BMI will be calculated as the difference between baseline and Day 28 values.
Measured: Baseline to Day 28
Change in Body Fat Percentage (%)
Body fat percentage (%) will be assessed using bioelectrical impedance analysis (BIA) under standardized conditions. The change in body fat percentage will be calculated as the difference between baseline and Day 28 measurements.
Measured: Baseline to Day 28
Change in Lean Mass Percentage (%)
Lean mass percentage (%) will be assessed using bioelectrical impedance analysis (BIA) under standardized conditions. The change in lean mass percentage will be calculated as the difference between baseline and Day 28 measurements.
Measured: Baseline to Day 28
Change in Vivifrail Physical Performance Battery Total Score (points)
Changes in physical performance will be assessed using the Vivifrail Physical Performance Battery (VPPB), a standardized functional assessment that evaluates lower-limb strength, balance, gait speed, and functional capacity in older adults.
The total score ranges from 0 to 12 points, with higher scores indicating better physical performance. The primary outcome will be the change in the total VPPB score, calculated as the difference between baseline and Day 28 measurements.
[Time Frame: Baseline to Day 28].
Measured: Baseline to Day 28
Change in Protein Intake (g/day)
Dietary intake will be assessed using 3-day food records collected at baseline and during the last week of the intervention. Mean daily protein intake will be calculated and expressed in grams per day (g/day) using EasyDiet software. The change in protein intake will be calculated as the difference between baseline and Day 28 values.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 May 2024
- Primary completion22 Dec 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as a parallel, randomized, double-blind clinical trial. Participants were randomly assigned to one of two intervention arms: an insect-based protein supplementation group (INSECT) or a control group (CONTROL), both combined with the same structured and supervised physical activity program. Randomization was performed using a computerized system, and both participants and investigators were blinded to group allocation. The dietary intervention consisted of three cookies per day, consumed on each exercise day immediately after the training session (within 15 minutes post-exercise). In the INSECT group, the cookies provided 35 g/day of Tenebrio molitor flour, corresponding to 23.6 g of total protein (20.3 g animal protein and 3.3 g plant protein). In the CONTROL group, the cookies provided 6.5 g/day of total protein, entirely of plant origin. The INSECT cookies weighed 104 g/day and provided 274 kcal, whereas CONTROL cookies weighed 103 g/day and provided 399 kcal
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Oberta de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gemma Chiva-Blanch, PhD, Universitat Oberta de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456319
- Sponsor's protocol ID
- RA2024
- Other IDs
- RA2024.
- Acronym
- SIPSE
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ros-Baro M, Puig MC, Chiva-Blanch G, Diaz-Rizzolo DA, Martinez AA, Rafart MJ, Chiriac I, Rogel MB, Cunill MP, Casas-Agustench P, Bach-Faig A. Enrichment of Pasteurized Dairy Product and Brownie With Edible Insect (Tenebrio molitor) to Analyze Acceptance Using Check-All-That-Apply Methodology. Food Sci Nutr. 2025 Oct 30;13(11):e70925. doi: 10.1002/fsn3.70925. eCollection 2025 Nov.
PubMed 41179365Ros-Baro M, Casas-Agustench P, Diaz-Rizzolo DA, Batlle-Bayer L, Adria-Acosta F, Aguilar-Martinez A, Medina FX, Pujola M, Bach-Faig A. Edible Insect Consumption for Human and Planetary Health: A Systematic Review. Int J Environ Res Public Health. 2022 Sep 15;19(18):11653. doi: 10.3390/ijerph191811653.
PubMed 36141915Ros-Baro M, Sanchez-Socarras V, Santos-Pages M, Bach-Faig A, Aguilar-Martinez A. Consumers' Acceptability and Perception of Edible Insects as an Emerging Protein Source. Int J Environ Res Public Health. 2022 Nov 26;19(23):15756. doi: 10.3390/ijerph192315756.
PubMed 36497830Ishara J, Ekaette I, Matendo R, Vandenberg G, Niassy S, Katcho K, Kinyuru J. Potential health benefits of insect bioactive metabolites and consumer attitudes towards edible insects. NPJ Sci Food. 2025 Sep 26;9(1):195. doi: 10.1038/s41538-025-00549-x.
PubMed 41006283
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Insect-based Protein Supplement in the Elderly: a Pilot Study
- ClinicalTrials.gov ID
- NCT07456319
- Acronym / sponsor ID
- SIPSE / RA2024
- Conditions
- Aging, Nutrition, Sustainable Diets, Cardiometabolic Health
- Keywords
- Feasibility trial, Edible insects, Tenebrio molitor, Older adults, Protein supplementation, Cardiometabolic health, Sustainable nutrition, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitat Oberta de CatalunyaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 6 Mar 2026 (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.
This pilot randomized, double-blind, controlled trial evaluated the effects of a Tenebrio molitor-enriched protein biscuit combined with a structured physical activity program on cardiometabolic health in older adults. Participants aged 65 years and older were assigned to receive either insect-based or control biscuits following supervised exercise sessions for 28 days. Primary outcomes focused on changes in lipid profile, while secondary outcomes included anthropometric measures, body composition, blood pressure, physical function, glucose metabolism, hepatic function and inflammatory biomarkers.
Detailed description
Population aging and increasing environmental pressures on food systems underscore the need for sustainable dietary strategies that support healthy aging. Edible insects, such as Tenebrio molitor, provide high-quality protein with a substantially lower environmental footprint than conventional livestock and may represent a viable alternative protein source for older adults.
This pilot randomized, double-blind, parallel, controlled study was conducted in community-dwelling adults aged 60 years and older recruited from the Barcelona metropolitan area. Participants were randomly assigned to either an insect-based protein supplementation group or a control group. Both groups participated in an identical supervised physical activity program consisting of strength and resistance exercises performed three times per week over a 28-day intervention period.
The insect-based intervention consisted of three cookies per day, providing 35 g of Tenebrio molitor flour. Control cookies were wheat flour-based and matched for palatability and texture. Cookie consumption was supervised by a dietitian immediately after exercise sessions to ensure compliance. Participants were instructed to maintain their habitual diet and lifestyle throughout the study.
Primary outcomes included changes in conventional lipid profile parameters. Secondary outcomes comprised body weight, body composition, blood pressure, muscle strength and physical performance, glucose metabolism, hepatic enzymes, inflammatory biomarkers, advanced lipoprotein profiling, and plasma low-molecular-weight metabolites. Dietary intake was assessed using 3-day food records, and fasting blood samples were collected at baseline and post-intervention.
In addition, acceptability and organoleptic perception of the intervention products were evaluated using structured questionnaires, assessing taste, texture, appearance, and overall satisfaction. Gastrointestinal tolerance, including symptoms such as bloating, discomfort, and changes in bowel habits, was systematically recorded throughout the intervention. Participants' willingness to continue consuming the insect-based product after study completion was also assessed to explore feasibility and long-term adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study was designed as a parallel, randomized, double-blind clinical trial. Participants were randomly assigned to one of two intervention arms: an insect-based protein supplementation group (INSECT) or a control group (CONTROL), both combined with the same structured and supervised physical activity program. Randomization was performed using a computerized system, and both participants and investigators were blinded to group allocation. The dietary intervention consisted of three cookies per day, consumed on each exercise day immediately after the training session (within 15 minutes post-exercise). In the INSECT group, the cookies provided 35 g/day of Tenebrio molitor flour, corresponding to 23.6 g of total protein (20.3 g animal protein and 3.3 g plant protein). In the CONTROL group, the cookies provided 6.5 g/day of total protein, entirely of plant origin. The INSECT cookies weighed 104 g/day and provided 274 kcal, whereas CONTROL cookies weighed 103 g/day and provided 399 kcal
| Arm | Type | Receives |
|---|---|---|
| INSECT | Experimental | Dietary Supplement: INSECT - Protein suplement based on edible insect flourParticipants consumed three Tenebrio molitor-enriched cookies per day (35 g insect flour/day) immediately after supervised exercise sessions, three times per week for 28 days. |
| CONTROL | Placebo comparator | Dietary Supplement: ControlParticipants consumed three wheat flour-based control cookies per day immediately after supervised exercise sessions, three times per week for 28 days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 60 years
- Body mass index (BMI) between 18.5 and 30.0 kg/m²
- Mini-Mental State Examination (MMSE) score ≥ 16
- Independent in basic activities of daily living
- Mini Nutritional Assessment-Short Form (MNA-SF) score ≥ 8
Key exclusion criteria (8 listed)
- Food Neophobia Scale score > 4
- Chronic diseases affecting metabolism or nutritional status
- Dependency or severe functional impairment
- Current or past use of medications or supplements affecting body weight or metabolic function
- Excessive alcohol consumption
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 |
|---|---|---|
| INSECT - Protein suplement based on edible insect flourParticipants received a protein suplement in the form of cookies based on edible insect flour. | Dietary supplement | INSECT |
| ControlControl placebo | Dietary supplement | CONTROL |
Primary outcome
Lipid profile
Time frame: One month (baseline and after the intervention)
Changes in lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) and lipid particles (small, medium and large lipoproteins) Description: Changes in the lipid profile were assessed by measuring fasting plasma concentrations of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides at baseline and after the intervention. In addition, detailed lipoprotein particle profiling was performed to quantify the concentration and size distribution of lipoproteins, including small, medium, and large subclasses of LDL, HDL, and very-low-density lipoproteins (VLDL). These measures allowed evaluation of both conventional lipid parameters and qualitative changes in lipoprotein particle composition associated with the intervention.
15 secondary outcomes
Body Weight (Kg)
Time frame: Baseline to 28 days
Change in blood pressure (mmHg) .
Time frame: Baseline to 28 days
Change in Handgrip Strength (kg)
Time frame: Baseline to 28 days
Change in glucose (mg/dL).
Time frame: Baseline to 28 days
Change in hepatic enzymes (ALT, AST, GGT)
Time frame: Baseline to 28 days
Change in inflammatory biomarkers
Time frame: Baseline to 28 days
Change in plasma low molecular weight metabolite
Time frame: Baseline to 28 days
Change in plasma and red blood cells fatty acids
Time frame: Baseline to 28 days
Changes in Energy Intake (kcal/day)
Time frame: Frame: Baseline to 28 days
Changes in Dietary Carbon Footprint (kg CO₂-eq/day)
Time frame: Baseline to 28 days
Change in Body Mass Index (kg/m²)
Time frame: Baseline to Day 28
Change in Body Fat Percentage (%)
Time frame: Baseline to Day 28
Change in Lean Mass Percentage (%)
Time frame: Baseline to Day 28
Change in Vivifrail Physical Performance Battery Total Score (points)
Time frame: Baseline to Day 28
Change in Protein Intake (g/day)
Time frame: Baseline to Day 28
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 9 Mar 2026.
- Background: PubMed 41179365Ros-Baro M, Puig MC, Chiva-Blanch G, Diaz-Rizzolo DA, Martinez AA, Rafart MJ, Chiriac I, Rogel MB, Cunill MP, Casas-Agustench P, Bach-Faig A. Enrichment of Pasteurized Dairy Product and Brownie With Edible Insect (Tenebrio molitor) to Analyze Acceptance Using Check-All-That-Apply Methodology. Food Sci Nutr. 2025 Oct 30;13(11):e70925. doi: 10.1002/fsn3.70925. eCollection 2025 Nov.
- Background: PubMed 36141915Ros-Baro M, Casas-Agustench P, Diaz-Rizzolo DA, Batlle-Bayer L, Adria-Acosta F, Aguilar-Martinez A, Medina FX, Pujola M, Bach-Faig A. Edible Insect Consumption for Human and Planetary Health: A Systematic Review. Int J Environ Res Public Health. 2022 Sep 15;19(18):11653. doi: 10.3390/ijerph191811653.
- Background: PubMed 36497830Ros-Baro M, Sanchez-Socarras V, Santos-Pages M, Bach-Faig A, Aguilar-Martinez A. Consumers' Acceptability and Perception of Edible Insects as an Emerging Protein Source. Int J Environ Res Public Health. 2022 Nov 26;19(23):15756. doi: 10.3390/ijerph192315756.
- Background: PubMed 41006283Ishara J, Ekaette I, Matendo R, Vandenberg G, Niassy S, Katcho K, Kinyuru J. Potential health benefits of insect bioactive metabolites and consumer attitudes towards edible insects. NPJ Sci Food. 2025 Sep 26;9(1):195. doi: 10.1038/s41538-025-00549-x.
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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 INSECT - Protein suplement based on edible insect flour in people with Aging and Nutrition, run by Universitat Oberta de Catalunya 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 6 inclusion and 8 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 9 Mar 2026. 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?
Lipid profile (time frame: One month (baseline and after the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07456319, which also lists 4 linked publications.
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 9 Mar 2026.