NCT06875674

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 7, 2025

Last Update Submit

March 7, 2025

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (1)

  • Measurement of selenium concentration in participants

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

    30 days

Secondary Outcomes (9)

  • Measurement of glucose in participants

    30 days

  • Measurement of insulin in participants

    30 days

  • Measurement of insulin resistance in participants

    30 days

  • Measurement of insulin sensitivity in participants

    30 days

  • Measurement of β-cell function in participants

    30 days

  • +4 more secondary outcomes

Other Outcomes (4)

  • Measurement of Height in participants

    baseline

  • Measurement of body weight in participants

    30 days

  • Measurement of body mass index (BMI) in participants

    30 days

  • +1 more other outcomes

Study Arms (3)

Control group

PLACEBO COMPARATOR

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

Selenium-biofortified strawberry supplementation

ACTIVE COMPARATOR

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

Tablet Selenium supplementation

ACTIVE COMPARATOR

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

Dietary Supplement: supplementation with selenium in tablet

Interventions

supplementation with control strawberryDIETARY_SUPPLEMENT

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

Control group
supplementation with biofortified strawberryDIETARY_SUPPLEMENT

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

Selenium-biofortified strawberry supplementation
supplementation with selenium in tabletDIETARY_SUPPLEMENT

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

Tablet Selenium supplementation

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20 - 65 years
  • Italian Ethnicity
  • Body mass index between 18.5 and 28.5 kg/m²
  • Clinically Healthy

You may not qualify if:

  • Chronic disease
  • Use of drugs (excluding occasional over the counter medications)
  • Pregnancy
  • Exogenous hormone use
  • Breastfeeding
  • Use of supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Palermo, PA, 90141, Italy

Location

MeSH Terms

Interventions

Dietary SupplementsSeleniumTablets

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesChalcogensElementsInorganic ChemicalsMineralsDosage FormsPharmaceutical Preparations

Study Officials

  • Sara Baldassano

    NABbio, STEBICEF department Palermo, Italy, 90128

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 13, 2025

Study Start

March 7, 2024

Primary Completion

June 30, 2024

Study Completion

September 29, 2024

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

IT(1)