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Completed

NCT Number: NCT06875674

Selenium Biofortification of Strawberries

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).

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Key information

Conditions

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University

Palermo, PA, 90141, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

supplementation with control strawberry

Dietary Supplement

control strawberry supplementation (100 grams/day) for 30 days

supplementation with biofortified strawberry

Dietary Supplement

selenium biofortified strawberry supplementation (100 grams/day) for 30 days

supplementation with selenium in tablet

Dietary Supplement

selenium supplementation in tablet (100 micrograms/day) for 30 days

Primary outcomes

  1. Measurement of selenium concentration in participants

    Time frame: 30 days

    Selenium (μg/L) will be measured in serum at baseline and after 30 days

Secondary outcomes

  1. Measurement of glucose in participants

    Time frame: 30 days

    Glucose (mg/dL) will be measured in serum at baseline and after 30 days

  2. Measurement of insulin in participants

    Time frame: 30 days

    Insulin (mUI/L) will be measured in serum at baseline and after 30 days

  3. Measurement of insulin resistance in participants

    Time frame: 30 days

    Insulin resistance (HOMA-IR) will be calculated from fasting glucose and insulin levels at baseline and after 30 days

  4. Measurement of insulin sensitivity in participants

    Time frame: 30 days

    Insulin sensitivity (QUICKI) will be calculated from fasting glucose and insulin levels at baseline and after 30 days

  5. Measurement of β-cell function in participants

    Time frame: 30 days

    β-cell function (HOMA-β) will be calculated from fasting glucose and insulin levels at baseline and after 30 days

  6. Measurement of aminotransferase (AST) in participants

    Time frame: 30 days

    AST (U/L) will be measured in serum at baseline and after 30 daysbaseline and after 30 days

  7. Measurement of alanine aminotransferase (ALT) in participants

    Time frame: 30 days

    ALT (U/L) will be measured in serum at baseline and after 30 days

  8. Measurement of gamma-glutamyl transferase (GGT) in participants

    Time frame: 30 days

    GGT (U/L) will be measured in serum at baseline and after 30 days

  9. Measurement of albumin (ALB) in participants

    Time frame: 30 days

    ALB (g/dL) will be measured in serum at baseline and after 30 days

Other outcomes

  1. Measurement of Height in participants

    Time frame: baseline

    Height (meters) will be assessed at baseline

  2. Measurement of body weight in participants

    Time frame: 30 days

    Body weight (kg) will be assessed at baseline and after 30 days

  3. Measurement of body mass index (BMI) in participants

    Time frame: 30 days

    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)

  4. Measurement of body composition in participants

    Time frame: 30 days

    Lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 30 days

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Selenium Biofortification of Strawberries and Human Intervention

Acronym: SeStra30Days

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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