NCT06875674

Selenium Biofortification of Strawberries

Selenium Biofortification of Strawberries and Human Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Palermo · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nutrition, Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	supplementation with control strawberry	control strawberry supplementation (100 grams/day) for 30 days
DIETARY_SUPPLEMENT	supplementation with biofortified strawberry	selenium biofortified strawberry supplementation (100 grams/day) for 30 days
DIETARY_SUPPLEMENT	supplementation with selenium in tablet	selenium supplementation in tablet (100 micrograms/day) for 30 days

Timeline

• Start date: 2024-03-07
• Primary completion: 2024-06-30
• Completion: 2024-09-29
• First posted: 2025-03-13
• Last updated: 2025-03-13

Locations

1 site across 1 country: Italy