NCT04984746

Brief Summary

The aim of the project is to study the influence of Lettuce crop enriched with Molybdenum and lettuce enriched with Iodine administrated at the same time on healthy population in order to assess influence on hematological parameter and Thyroid hormones. Secondary outcome will be to find out Molybdenum and Iodine presence in urine in order to evaluate vegetables as biocarrier and any additive effect when administrated all together.

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 Apr 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

July 18, 2021

Last Update Submit

July 28, 2021

Conditions

Healthy Diet

Keywords

functional foodIodineMolybdenum

Outcome Measures

Primary Outcomes (2)

  • Urine Molybdenum and Iodine concentration

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

    10 days

  • Hematology and serum chemistry measurements

    (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), AST (mg/dL), ALT (mg/dL), γ-GT(mg/dL), ALP(mg/dL), Ferritin (mg/dL), free Iron (mg/dL), transferrin (mg/dL), total proteins (mg/dL), Magnesium (mg/dL), Calcium (mg/dL), insulin (mg/dL), Vitamin D (mg/dL), HCRP (mg/dL), Potassium (mg/dL), Phosphate (mg/dL) All these measurements will be assessed at baseline and after 10 days

    10 days

Secondary Outcomes (6)

  • body mass index (BMI)

    10 days

  • body composition

    10 days

  • Oxidative stress markers

    10 days

  • Bone turnover markers

    10 days

  • Gastric hormones

    10 days

  • +1 more secondary outcomes

Study Arms (2)

No Intervention: (control group)

EXPERIMENTAL

No Intervention: (control group) The control group was assigned to lettuce without any biofortification but with the same characteristic of bioforticated lettuce(soil, water, harvesting time).

Dietary Supplement: No Intervention: (control group)

Experimental: intervention group

EXPERIMENTAL

Experimental: intervention group To the intervention group was assigned the biofortificated Molibdenum lettuce and Iodine lettuce.

Dietary Supplement: Experimental: intervention group

Interventions

No Intervention: (control group)DIETARY_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)
Experimental: intervention groupDIETARY_SUPPLEMENT

Molybdenum Iodine group Lettuces with Iodine and Molybdenum biofortification was assigned to each participant belonging to the intervention group which ate 100gr of each type of lattuce 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, PA, 90141, Italy

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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 2, 2021

Study Start

April 2, 2021

Primary Completion

June 30, 2021

Study Completion

July 15, 2021

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations

IT(1)