NCT05011968

Brief Summary

The aim of the project is to study of the influence of Lettuce crop enriched with Iodine on Thyroid hormone synthesis. Secondary outcome to find out iodine presence in urine in order to evaluate vegetables, like little crop, as Iodine biocarrier

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
Last Updated

August 18, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

July 18, 2021

Last Update Submit

August 16, 2021

Conditions

Healthy Individuals

Keywords

functional foodbiocarrierIodine

Outcome Measures

Primary Outcomes (7)

  • Serum Thyroid markers

    serum levels of free tri-iodothyronine (FT3 ng/L), free thyroxine (FT4 ng/L) and thyroid-stimulating hormone (TSH ng/L) will be assessed at baseline and after 10 days

    10 days

  • Urine Iodine concentration

    Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days

    10 days

  • Haematology and serum chemistry values 1

    glucose (mg/dL), albumin( mg/dL), total cholesterol (mg/dL), HDL-cholesterol (mg/dL), LDL-cholesterol (mg/dL), triglycerides(mg/dL), uric acid(mg/dL), creatinine(mg/dL) will be assessed at baseline and after 10 days

    10 days

  • Haematology and serum chemistry values 2

    insulin (mUI/L) will be assessed at baseline and after 10 days

    10 days

  • Haematology and serum chemistry values 3

    Potassium (mmol/L) will be assessed at baseline and after 10 days

    10 days

  • Haematology and serum chemistry values 4

    Ferritin (mg/L), free Iron (mg/L), transferrin (mg/L), total proteins (mg/L), Magnesium (mg/L), Calcium (mg/L), Vitamin D (mg/L), HCRP (mg/L), Phosphate (mg/L), Cortisol (mg/L)will be assessed at baseline and after 10 days

    10 days

  • Haematology and serum chemistry values 5

    AST (U/L), ALT (U/L), γ-GT(U/L), ALP(U/L) will be assessed at baseline and after 10 days

    10 days

Secondary Outcomes (8)

  • body mass index (BMI)

    10 days

  • body composition (%)

    10 days

  • Gastric Hormones

    10 days

  • Oxidative stress markes

    10 days

  • Bone metabolism

    10 days

  • +3 more secondary outcomes

Study Arms (2)

No Intervention: (control group)

EXPERIMENTAL

The control group was assigned to crop lettuce without any biofortification but with the same characteristic of bioforticated lettuce (soil, water, harvesting time)

Dietary Supplement: Lettuce with not biofortification

Experimental: intervention group

EXPERIMENTAL

The intervention group was assigned to biofortificated Iodine crop lettuce.

Dietary Supplement: Lettuce biofortificated with Iodine

Interventions

Lettuce with not biofortificationDIETARY_SUPPLEMENT

Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days

No Intervention: (control group)
Lettuce biofortificated with IodineDIETARY_SUPPLEMENT

Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days

Experimental: intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasian
  • age: 18-65 years
  • healthy status
  • no drug therapy or integration therapy

You may not qualify if:

  • Inflammatory chronic disease
  • use of medication or suffering from any condition
  • pregnancy
  • breastfeeding
  • current smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Palermo, 90141, Italy

Location

MeSH Terms

Interventions

Iodine

Intervention Hierarchy (Ancestors)

HalogensElementsInorganic Chemicals

Study Officials

  • Sonya Vasto, PhD

    D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study were designed by two cohorts The control group and the interventional group. The intervention lasted for 10 days and 100gr of lettuce per day was consumed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 18, 2021

First Posted

August 18, 2021

Study Start

March 1, 2019

Primary Completion

June 26, 2019

Study Completion

January 30, 2020

Last Updated

August 18, 2021

Record last verified: 2021-08

Locations

IT(1)