Selenium Biofortification of Strawberries (SeStra30Days)

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).

Study Overview

• Status: Completed
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Dietary supplement: supplementation with control strawberry; Dietary supplement: supplementation with biofortified strawberry; Dietary supplement: supplementation with selenium in tablet

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PA
    • Palermo, PA, Italy, 90141
      • Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; 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	Dietary supplement: supplementation with control strawberry; control strawberry supplementation (100 grams/day) for 30 days
Active Comparator: Selenium-biofortified strawberry supplementation; This group will received selenium biofortified strawberries (100grams/day) with the same characteristic of control strawberries lettuce(soil, water, harvesting time) for 30 days	Dietary supplement: supplementation with biofortified strawberry; selenium biofortified strawberry supplementation (100 grams/day) for 30 days
Active Comparator: Tablet Selenium supplementation; This group will received selenium in tablet (100 micrograms/day) for 30 days	Dietary supplement: supplementation with selenium in tablet; selenium supplementation in tablet (100 micrograms/day) for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of selenium concentration in participants	Selenium (μg/L) will be measured in serum at baseline and after 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of glucose in participants	Glucose (mg/dL) will be measured in serum at baseline and after 30 days	30 days
Measurement of insulin in participants	Insulin (mUI/L) will be measured in serum at baseline and after 30 days	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	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	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	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	30 days
Measurement of alanine aminotransferase (ALT) in participants	ALT (U/L) will be measured in serum at baseline and after 30 days	30 days
Measurement of gamma-glutamyl transferase (GGT) in participants	GGT (U/L) will be measured in serum at baseline and after 30 days	30 days
Measurement of albumin (ALB) in participants	ALB (g/dL) will be measured in serum at baseline and after 30 days	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Height in participants	Height (meters) will be assessed at baseline	baseline
Measurement of body weight in participants	Body weight (kg) will be assessed at baseline and after 30 days	30 days
Measurement of body mass index (BMI) in participants	Weight in kilograms, height in meters will be aggregated to arrive at one reported value (weight and height will be combined to report BMI in kg/m²)	30 days
Measurement of body composition in participants	Lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 30 days	30 days

Collaborators and Investigators

• Sponsor: University of Palermo
• Investigators: Principal Investigator: Sara Baldassano, NABbio, STEBICEF department Palermo, Italy, 90128

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): September 29, 2024

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Trace Elements; Micronutrients; Antioxidants; Protective Agents; Selenium
• Other Study ID Numbers: SeStraw30Days24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No