Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
Palermo, PA, 90141, Italy
NCT Number: NCT06875674
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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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Palermo, PA, 90141, Italy
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.
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
control strawberry supplementation (100 grams/day) for 30 days
selenium biofortified strawberry supplementation (100 grams/day) for 30 days
selenium supplementation in tablet (100 micrograms/day) for 30 days
Time frame: 30 days
Selenium (μg/L) will be measured in serum at baseline and after 30 days
Time frame: 30 days
Glucose (mg/dL) will be measured in serum at baseline and after 30 days
Time frame: 30 days
Insulin (mUI/L) will be measured in serum at baseline and after 30 days
Time frame: 30 days
Insulin resistance (HOMA-IR) will be calculated from fasting glucose and insulin levels at baseline and after 30 days
Time frame: 30 days
Insulin sensitivity (QUICKI) will be calculated from fasting glucose and insulin levels at baseline and after 30 days
Time frame: 30 days
β-cell function (HOMA-β) will be calculated from fasting glucose and insulin levels at baseline and after 30 days
Time frame: 30 days
AST (U/L) will be measured in serum at baseline and after 30 daysbaseline and after 30 days
Time frame: 30 days
ALT (U/L) will be measured in serum at baseline and after 30 days
Time frame: 30 days
GGT (U/L) will be measured in serum at baseline and after 30 days
Time frame: 30 days
ALB (g/dL) will be measured in serum at baseline and after 30 days
Time frame: baseline
Height (meters) will be assessed at baseline
Time frame: 30 days
Body weight (kg) will be assessed at baseline and after 30 days
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)
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
University of Palermo
Other
Selenium Biofortification of Strawberries and Human Intervention
Acronym: SeStra30Days
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