Selenium Biofortification of Strawberries

Not Applicable

Completed

• Conditions: Nutrition, Healthy

• Registration Number: NCT06875674
• Lead Sponsor: University of Palermo

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.

Study Timeline

• Study Start: 2024-03-07
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-29
• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Measurement of selenium concentration in participants	30 days	Selenium (μg/L) will be measured in serum at baseline and after 30 days

Secondary Outcome Measures

Name	Time	Method
Measurement of insulin resistance in participants	30 days	Insulin resistance (HOMA-IR) will be calculated from fasting glucose and insulin levels at baseline and after 30 days
Measurement of insulin in participants	30 days	Insulin (mUI/L) will be measured in serum at baseline and after 30 days
Measurement of aminotransferase (AST) in participants	30 days	AST (U/L) will be measured in serum at baseline and after 30 daysbaseline and after 30 days
Measurement of alanine aminotransferase (ALT) in participants	30 days	ALT (U/L) will be measured in serum at baseline and after 30 days
Measurement of glucose in participants	30 days	Glucose (mg/dL) will be measured in serum at baseline and after 30 days
Measurement of insulin sensitivity in participants	30 days	Insulin sensitivity (QUICKI) will be calculated from fasting glucose and insulin levels at baseline and after 30 days
Measurement of β-cell function in participants	30 days	β-cell function (HOMA-β) will be calculated from fasting glucose and insulin levels at baseline and after 30 days
Measurement of gamma-glutamyl transferase (GGT) in participants	30 days	GGT (U/L) will be measured in serum at baseline and after 30 days
Measurement of albumin (ALB) in participants	30 days	ALB (g/dL) will be measured in serum at baseline and after 30 days

Trial Locations

Locations (1)

Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University; 🇮🇹 Palermo, PA, Italy