Clinical trial NCT06875674: Selenium Biofortification of Strawberries
Official title: Selenium Biofortification of Strawberries and Human Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Healthy
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

3. 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.

Eligibility criteria: Inclusion Criteria:

* Age 20 - 65 years
* Italian Ethnicity
* Body mass index between 18.5 and 28.5 kg/m²
* Clinically Healthy

Exclusion Criteria:

* Chronic disease
* Use of drugs (excluding occasional over the counter medications)
* Pregnancy
* Exogenous hormone use
* Breastfeeding
* Use of supplements

Primary outcomes:
measure: Measurement of selenium concentration in participants
timeFrame: 30 days
Secondary outcomes:
measure: Measurement of glucose in participants
timeFrame: 30 days
measure: Measurement of insulin in participants
timeFrame: 30 days
measure: Measurement of insulin resistance in participants
timeFrame: 30 days
measure: Measurement of insulin sensitivity in participants
timeFrame: 30 days
measure: Measurement of β-cell function in participants
timeFrame: 30 days
measure: Measurement of aminotransferase (AST) in participants
timeFrame: 30 days
measure: Measurement of alanine aminotransferase (ALT) in participants
timeFrame: 30 days
measure: Measurement of gamma-glutamyl transferase (GGT) in participants
timeFrame: 30 days
measure: Measurement of albumin (ALB) in participants
timeFrame: 30 days
Other outcomes:
measure: Measurement of Height in participants
timeFrame: baseline
measure: Measurement of body weight in participants
timeFrame: 30 days
measure: Measurement of body mass index (BMI) in participants
timeFrame: 30 days
measure: Measurement of body composition in participants
timeFrame: 30 days
Locations:
city: Palermo
country: Italy
facility: Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
state: PA
Study officials:
affiliation: NABbio, STEBICEF department Palermo, Italy, 90128
name: Sara Baldassano
role: PRINCIPAL_INVESTIGATOR
References: