Healthy IndividualsNutri-I-FoodNCT05011968
Intervention Study on Iodine Biofortification Vegetables ( Nutri-I-Food
A study testing Lettuce with not biofortification and Lettuce biofortificated with Iodine in people with Healthy Individuals, run by University of Palermo at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Lettuce with not biofortification and Lettuce biofortificated with Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian
- age: 18-65 years
- healthy status
- no drug therapy or integration therapy
Who cannot join
- Inflammatory chronic disease
- use of medication or suffering from any condition
- pregnancy
- breastfeeding
- current smokers
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
Palermo, 90141
About this study
Official title: Intervention Study With Crop Lettuce Enriched With Iodine
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
Read the detailed description
Several human pathologies are caused by deficiencies of some mineral elements. These deficiencies can be overcome through careful dietary diversification and mineral supplementation. An alternative or even complementary way is represented by the intake of bio-fortified foods. In the field of mineral deficiency increasing the bioavailable mineral concentration in vegetables intended for human consumption; can be a useful tool to prevent many harmful pathologies. Therefore, in this scenario, it appears very important to identify the right dosages and the most effective methods of administration to bio-fortify vegetables with a strong nutritional-health connotation.
The present project aim to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, healthy individuals received lettuce enriched with iodine and after 10 days plasma and urine samples were collected . Each subject was subjected to two venous blood samples taken at the beginning of the observation and at the end (after 10 days). The samples thus obtained were transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin,TSH, FT3, FT4, hematocrit, hs-CRP, Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK) oxidative stress markers (LDL-ox, AGE, urinary 8-iso-prostaglandin F (PGF)2alpha) and inflammatory markers(IL-1, TNF, IL-6, IL-10)
- Conditions
- Healthy Individuals
- Being tested
- Lettuce with not biofortification, Lettuce biofortificated with Iodine
- Keywords
- functional food, biocarrier, Iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: Lettuce with not biofortification |
| Experimental: intervention group | Experimental | The intervention group was assigned to biofortificated Iodine crop lettuce. Receives: Dietary Supplement: Lettuce biofortificated with Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Urine Iodine concentration
Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days
Measured: 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
Measured: 10 days
Haematology and serum chemistry values 2
insulin (mUI/L) will be assessed at baseline and after 10 days
Measured: 10 days
Haematology and serum chemistry values 3
Potassium (mmol/L) will be assessed at baseline and after 10 days
Measured: 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
Measured: 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
Measured: 10 days
Secondary outcomes (8)
body mass index (BMI)
BMI (kg/m2) All these measurements will be assessed at baseline and after 10 days
Measured: 10 days
body composition (%)
lean mass as percent of body weight and fat mass as percent of body weight will be assessed at baseline and after 10 days
Measured: 10 days
Gastric Hormones
GIP (pg/m), GLP1 (pg/m), GLP2 (pg/m), ghrelin (pg/m), glucagon (pg/m), PYY (pg/m), CCK(pg/m) measured in plasma will be assessed at baseline and after 10 days
Measured: 10 days
Oxidative stress markes
LDL-ox (ug/mL), AGE(ng/mL), urinary 8-iso-prostaglandin F (PGF)2alpha (ng/mL) will be assessed at baseline and after 10 days
Measured: 10 days
Bone metabolism
Osteocalcin(ng/L), parathyroid hormone (ng/L), CTX, Calcitonin (ng/L) measured in plasma will be assessed at baseline and after 10 days
Measured: 10 days
Inflammatory markers
IL-1 (pg/mL), TNF(pg/mL), IL-6(pg/mL), IL-10(pg/mL) measured in plasma will be assessed at baseline and after 10 days
Measured: 10 days
Weigh
Weight (Kg) will be assessed at baseline and after 10 days
Measured: 10 days
Hight
Hight (m) will be assessed at baseline and after 10 days
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Mar 2019
- Primary completion26 Jun 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonya Vasto, University of Palermo
- Investigators
- Sonya Vasto, PhD, Principal investigator, D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011968
- Sponsor's protocol ID
- Nutr-I-Food2019
- Acronym
- Nutri-I-Food
- Status last verified
- Aug 2021
- First submitted
- 18 Jul 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study With Crop Lettuce Enriched With Iodine
- ClinicalTrials.gov ID
- NCT05011968
- Acronym / sponsor ID
- Nutri-I-Food / Nutr-I-Food2019
- Conditions
- Healthy Individuals
- Keywords
- functional food, biocarrier, Iodine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Several human pathologies are caused by deficiencies of some mineral elements. These deficiencies can be overcome through careful dietary diversification and mineral supplementation. An alternative or even complementary way is represented by the intake of bio-fortified foods. In the field of mineral deficiency increasing the bioavailable mineral concentration in vegetables intended for human consumption; can be a useful tool to prevent many harmful pathologies. Therefore, in this scenario, it appears very important to identify the right dosages and the most effective methods of administration to bio-fortify vegetables with a strong nutritional-health connotation.
The present project aim to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, healthy individuals received lettuce enriched with iodine and after 10 days plasma and urine samples were collected . Each subject was subjected to two venous blood samples taken at the beginning of the observation and at the end (after 10 days). The samples thus obtained were transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin,TSH, FT3, FT4, hematocrit, hs-CRP, Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK) oxidative stress markers (LDL-ox, AGE, urinary 8-iso-prostaglandin F (PGF)2alpha) and inflammatory markers(IL-1, TNF, IL-6, IL-10)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| No Intervention: (control group) | Experimental | Dietary Supplement: Lettuce with not biofortificationThe control group was assigned to crop lettuce without any biofortification but with the same characteristic of bioforticated lettuce (soil, water, harvesting time) |
| Experimental: intervention group | Experimental | Dietary Supplement: Lettuce biofortificated with IodineThe intervention group was assigned to biofortificated Iodine crop lettuce. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasian
- age: 18-65 years
- healthy status
- no drug therapy or integration therapy
Key exclusion criteria (5 listed)
- Inflammatory chronic disease
- use of medication or suffering from any condition
- pregnancy
- breastfeeding
- current smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lettuce with not biofortificationLettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days | Dietary supplement | No Intervention: (control group) |
| Lettuce biofortificated with IodineLettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days | Dietary supplement | Experimental: intervention group |
Primary outcome
Serum Thyroid markers
Time frame: 10 days
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
Urine Iodine concentration
Time frame: 10 days
Urine Iodine concentration (mg/l) will be assessed at baseline and after 10 days
Haematology and serum chemistry values 1
Time frame: 10 days
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
Haematology and serum chemistry values 2
Time frame: 10 days
insulin (mUI/L) will be assessed at baseline and after 10 days
Haematology and serum chemistry values 3
Time frame: 10 days
Potassium (mmol/L) will be assessed at baseline and after 10 days
Haematology and serum chemistry values 4
Time frame: 10 days
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
Haematology and serum chemistry values 5
Time frame: 10 days
AST (U/L), ALT (U/L), γ-GT(U/L), ALP(U/L) will be assessed at baseline and after 10 days
8 secondary outcomes
body mass index (BMI)
Time frame: 10 days
body composition (%)
Time frame: 10 days
Gastric Hormones
Time frame: 10 days
Oxidative stress markes
Time frame: 10 days
Bone metabolism
Time frame: 10 days
Inflammatory markers
Time frame: 10 days
Weigh
Time frame: 10 days
Hight
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonya Vasto, PhD principal investigator
D. Biological, Chemical and Pharmaceutical Sciences and Technologies, Palermo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lettuce with not biofortification and Lettuce biofortificated with Iodine in people with Healthy Individuals, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Thyroid markers (time frame: 10 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.