Selenium Biofortification of Strawberries (SeStra30Days)

University of Palermo

Status: Completed

Conditions: Nutrition, Healthy

Treatments: Dietary Supplement: supplementation with control strawberry; Dietary Supplement: supplementation with selenium in tablet; Dietary Supplement: supplementation with biofortified strawberry

Study type: Interventional

Funder types: Other

Identifiers

NCT06875674

SeStraw30Days24

Details and patient eligibility

About

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).

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: supplementation with control strawberry

Selenium-biofortified strawberry supplementation

Active Comparator group

Description:

This group will received selenium biofortified strawberries (100grams/day) with the same characteristic of control strawberries lettuce(soil, water, harvesting time) for 30 days

Treatment:

Dietary Supplement: supplementation with biofortified strawberry

Tablet Selenium supplementation

Active Comparator group

Description:

This group will received selenium in tablet (100 micrograms/day) for 30 days

Treatment:

Dietary Supplement: supplementation with selenium in tablet