Nutrition, HealthySeStra30DaysNCT06875674
Selenium Biofortification of Strawberries
A study testing supplementation with biofortified strawberry and supplementation with selenium in tablet in people with Nutrition, Healthy, run by University of Palermo at 1 site in Italy.
Trial summary
This study aims to investigate the effects of a nutritional intervention with selenium-biofortified strawberries on glucose homeostasis and hepatic function of healthy individuals. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- supplementation with biofortified strawberry and supplementation with selenium in tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 7 Mar 2024to 29 Sep 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20 - 65 years
- Italian Ethnicity
- Body mass index between 18.5 and 28.5 kg/m²
- Clinically Healthy
Who cannot join
- Chronic disease
- Use of drugs (excluding occasional over the counter medications)
- Pregnancy
- Exogenous hormone use
- Breastfeeding
- Use of supplements
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
Palermo, PA, 90141
About this study
Official title: Selenium Biofortification of Strawberries and Human Intervention
This study aims to investigate the effects of a nutritional intervention with selenium-biofortified strawberries on glucose homeostasis and hepatic function of healthy individuals. The study will assess if consumption of selenium-biofortified strawberries would increase the selenium endogenous concentration (primary outcome) and if it would impact, and to which extension, glucose homeostasis and hepatic function (secondary outcome).
Read the detailed description
Selenium is an essential micronutrient with antioxidant properties and a crucial role in various physiological processes. Biofortification of crops with selenium offers a promising strategy to enhance selenium intake and improve human health. Strawberries are a widely consumed fruit and can serve as an effective vehicle for selenium delivery. The effects of consuming selenium-biofortified strawberries on human health will be investigated.
- Study Goals and Objectives
The primary objective is to evaluate the impact of consuming selenium-biofortified strawberries for 30 days on serum selenium concentration in healthy adults. The secondary objective is to assess the influence of this intervention on glucose profile and hepatic function. • Fifty-five healthy adult volunteers (both sexes) will be randomly assigned to three groups:
- Control group: Consuming 100 grams of control strawberries daily.
- Intervention group (selenium-biofortified strawberries): Consuming 100 grams of selenium-biofortified strawberries daily.
- Intervention group (selenium supplement): Consuming a selenium supplement of 100 micrograms daily.
- The intervention period will be 30 days.
- Blood samples (serum and plasma) will be collected at baseline (T0) and at the end of the intervention (T30).
- Body weight, barefoot standing height, body mass index, and body composition will be measured at baseline and T30.
- Blood samples will be analyzed for:
- Selenium.
- Glucose
- Insulin
- insulin resistance
- insulin sensitivity
- β-cell function
- aminotransferase (AST)
- alanine aminotransferase (ALT)
- gamma-glutamyl transferase (GGT)
- albumin (ALB)
- Data will be recorded in a coded database to ensure participant privacy.
- Samples will be transported in certified containers for biological samples, and processed at the Molecular Biology section of the University of Palermo.
The statistical analyses will be carried out using specific software. To compare the baseline characteristics of the groups student t tests will be used. The comparison between the different groups of participants and within the same group between baseline and T30 will be carried out using One-Way ANOVA followed by Sidak test. Values will be expressed as mean ± standard deviation (mean ± SD). P-value ≤ 0.05 will be considered to be statistically significant.
- Conditions
- Nutrition, Healthy
- Being tested
- supplementation with control strawberry, supplementation with biofortified strawberry, supplementation with selenium in tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplementation with control strawberryDietary supplement
control strawberry supplementation (100 grams/day) for 30 days
supplementation with biofortified strawberryDietary supplement
selenium biofortified strawberry supplementation (100 grams/day) for 30 days
supplementation with selenium in tabletDietary supplement
selenium supplementation in tablet (100 micrograms/day) for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The control group received strawberries (control strawberries 100grams/day) that was without biofortification with the same characteristic of strawberries lettuce(soil, water, harvesting time) for 30 days Receives: Dietary Supplement: supplementation with control strawberry |
| Selenium-biofortified strawberry supplementation | Active comparator | This group will received selenium biofortified strawberries (100grams/day) with the same characteristic of control strawberries lettuce(soil, water, harvesting time) for 30 days Receives: Dietary Supplement: supplementation with biofortified strawberry |
| Tablet Selenium supplementation | Active comparator | This group will received selenium in tablet (100 micrograms/day) for 30 days Receives: Dietary Supplement: supplementation with selenium in tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of selenium concentration in participants
Selenium (μg/L) will be measured in serum at baseline and after 30 days
Measured: 30 days
Secondary outcomes (9)
Measurement of glucose in participants
Glucose (mg/dL) will be measured in serum at baseline and after 30 days
Measured: 30 days
Measurement of insulin in participants
Insulin (mUI/L) will be measured in serum at baseline and after 30 days
Measured: 30 days
Measurement of insulin resistance in participants
Insulin resistance (HOMA-IR) will be calculated from fasting glucose and insulin levels at baseline and after 30 days
Measured: 30 days
Measurement of insulin sensitivity in participants
Insulin sensitivity (QUICKI) will be calculated from fasting glucose and insulin levels at baseline and after 30 days
Measured: 30 days
Measurement of β-cell function in participants
β-cell function (HOMA-β) will be calculated from fasting glucose and insulin levels at baseline and after 30 days
Measured: 30 days
Measurement of aminotransferase (AST) in participants
AST (U/L) will be measured in serum at baseline and after 30 daysbaseline and after 30 days
Measured: 30 days
Measurement of alanine aminotransferase (ALT) in participants
ALT (U/L) will be measured in serum at baseline and after 30 days
Measured: 30 days
Measurement of gamma-glutamyl transferase (GGT) in participants
GGT (U/L) will be measured in serum at baseline and after 30 days
Measured: 30 days
Measurement of albumin (ALB) in participants
ALB (g/dL) will be measured in serum at baseline and after 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start7 Mar 2024
- Primary completion30 Jun 2024
- Study completion29 Sep 2024
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Baldassano, University of Palermo
- Investigators
- Sara Baldassano, Principal investigator, NABbio, STEBICEF department Palermo, Italy, 90128
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875674
- Sponsor's protocol ID
- SeStraw30Days24
- Acronym
- SeStra30Days
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenium Biofortification of Strawberries and Human Intervention
- ClinicalTrials.gov ID
- NCT06875674
- Acronym / sponsor ID
- SeStra30Days / SeStraw30Days24
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 13 Mar 2025 (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 study aims to investigate the effects of a nutritional intervention with selenium-biofortified strawberries on glucose homeostasis and hepatic function of healthy individuals. The study will assess if consumption of selenium-biofortified strawberries would increase the selenium endogenous concentration (primary outcome) and if it would impact, and to which extension, glucose homeostasis and hepatic function (secondary outcome).
Detailed description
Selenium is an essential micronutrient with antioxidant properties and a crucial role in various physiological processes. Biofortification of crops with selenium offers a promising strategy to enhance selenium intake and improve human health. Strawberries are a widely consumed fruit and can serve as an effective vehicle for selenium delivery. The effects of consuming selenium-biofortified strawberries on human health will be investigated.
- Study Goals and Objectives
The primary objective is to evaluate the impact of consuming selenium-biofortified strawberries for 30 days on serum selenium concentration in healthy adults. The secondary objective is to assess the influence of this intervention on glucose profile and hepatic function. • Fifty-five healthy adult volunteers (both sexes) will be randomly assigned to three groups:
- Control group: Consuming 100 grams of control strawberries daily.
- Intervention group (selenium-biofortified strawberries): Consuming 100 grams of selenium-biofortified strawberries daily.
- Intervention group (selenium supplement): Consuming a selenium supplement of 100 micrograms daily.
- The intervention period will be 30 days.
- Blood samples (serum and plasma) will be collected at baseline (T0) and at the end of the intervention (T30).
- Body weight, barefoot standing height, body mass index, and body composition will be measured at baseline and T30.
- Blood samples will be analyzed for:
- Selenium.
- Glucose
- Insulin
- insulin resistance
- insulin sensitivity
- β-cell function
- aminotransferase (AST)
- alanine aminotransferase (ALT)
- gamma-glutamyl transferase (GGT)
- albumin (ALB)
- Data will be recorded in a coded database to ensure participant privacy.
- Samples will be transported in certified containers for biological samples, and processed at the Molecular Biology section of the University of Palermo.
The statistical analyses will be carried out using specific software. To compare the baseline characteristics of the groups student t tests will be used. The comparison between the different groups of participants and within the same group between baseline and T30 will be carried out using One-Way ANOVA followed by Sidak test. Values will be expressed as mean ± standard deviation (mean ± SD). P-value ≤ 0.05 will be considered to be statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: supplementation with control strawberryThe control group received strawberries (control strawberries 100grams/day) that was without biofortification with the same characteristic of strawberries lettuce(soil, water, harvesting time) for 30 days |
| Selenium-biofortified strawberry supplementation | Active comparator | Dietary Supplement: supplementation with biofortified strawberryThis group will received selenium biofortified strawberries (100grams/day) with the same characteristic of control strawberries lettuce(soil, water, harvesting time) for 30 days |
| Tablet Selenium supplementation | Active comparator | Dietary Supplement: supplementation with selenium in tabletThis group will received selenium in tablet (100 micrograms/day) for 30 days |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 - 65 years
- Italian Ethnicity
- Body mass index between 18.5 and 28.5 kg/m²
- Clinically Healthy
Key exclusion criteria (6 listed)
- Chronic disease
- Use of drugs (excluding occasional over the counter medications)
- Pregnancy
- Exogenous hormone use
- Breastfeeding
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 |
|---|---|---|
| supplementation with control strawberrycontrol strawberry supplementation (100 grams/day) for 30 days | Dietary supplement | Control group |
| supplementation with biofortified strawberryselenium biofortified strawberry supplementation (100 grams/day) for 30 days | Dietary supplement | Selenium-biofortified strawberry supplementation |
| supplementation with selenium in tabletselenium supplementation in tablet (100 micrograms/day) for 30 days | Dietary supplement | Tablet Selenium supplementation |
Primary outcome
Measurement of selenium concentration in participants
Time frame: 30 days
Selenium (μg/L) will be measured in serum at baseline and after 30 days
9 secondary outcomes
Measurement of glucose in participants
Time frame: 30 days
Measurement of insulin in participants
Time frame: 30 days
Measurement of insulin resistance in participants
Time frame: 30 days
Measurement of insulin sensitivity in participants
Time frame: 30 days
Measurement of β-cell function in participants
Time frame: 30 days
Measurement of aminotransferase (AST) in participants
Time frame: 30 days
Measurement of alanine aminotransferase (ALT) in participants
Time frame: 30 days
Measurement of gamma-glutamyl transferase (GGT) in participants
Time frame: 30 days
Measurement of albumin (ALB) in participants
Time frame: 30 days
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 13 Mar 2025.
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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.
Sara Baldassano principal investigator
NABbio, STEBICEF department Palermo, Italy, 90128
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplementation with biofortified strawberry and supplementation with selenium in tablet in people with Nutrition, Healthy, run by University of Palermo at 1 site in Italy.
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 6 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 13 Mar 2025. 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 Italy. 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?
Measurement of selenium concentration in participants (time frame: 30 days). 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 13 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.