Nutrition, Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTsupplementation with control strawberry
control strawberry supplementation (100 grams/day) for 30 days
DIETARY_SUPPLEMENTsupplementation with biofortified strawberry
selenium biofortified strawberry supplementation (100 grams/day) for 30 days
DIETARY_SUPPLEMENTsupplementation with selenium in tablet
selenium supplementation in tablet (100 micrograms/day) for 30 days
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of selenium concentration in participants | 30 days | Selenium (μg/L) will be measured in serum at baseline and after 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| Measurement of glucose in participants | 30 days | Glucose (mg/dL) will be measured in serum 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 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 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measurement of body mass index (BMI) in participants | 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) |
| Measurement of body composition in participants | 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 |
| Measurement of body weight in participants | 30 days | Body weight (kg) will be assessed at baseline and after 30 days |
| Measurement of Height in participants | baseline | Height (meters) will be assessed at baseline |
Countries
Italy
Outcome results
None listed