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Completed

NCT Number: NCT06002672

Effects of Saline Eustress in Plant Food (ESEPF)

The aim of the project is to study if supplementation with eustress plant food like lettuce grown in mild salinity condition affects health in a healthy population.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NABbio, STEBICEF department

Palermo, 90128, Italy

About this study

Salinity can affect the levels of bioactive compounds in leafy vegetables. The aim of the project is to verify the impact, if any, of the changing of bioactive compounds in the physiology of the study population. The participants will be randomly assigned to the control group that will eat 100 gr of untreated (control) lettuce and the intervention group that will consume 100gr of eustress lettuce. Blood samples and urine samples will be collected at time zero (start) after 12 days. Each subject will be subjected to two venous blood samples taken at the beginning of the observation and at the end. The samples obtained will be transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the experimenters at 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, insulin, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, AST, ALT, GGT, ALP, Ferritin, free Iron, transferrin, total proteins, magnesium, calcium, insulin, osteocalcin, calcitonin, parathyroid hormone, c terminal peptide of collagen (CTX), Vitamin D, Phosphate, Potassium.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Italian
  • age: 18-65 years
  • currently injury free
  • Body mass index between 18.5 and 28 kg/m2

Exclusion criteria

  • Use of vitamins and minerals supplements,
  • use of medications
  • Presence of metabolic or chronic disease
  • Pregnancy, breastfeeding condition,
  • smokers

Treatment and study plan

Placebo comparator: Control group. To the control group was assigned lettuce without any change in salinity but with the same characteristic of eustress lettuce (soil, water, harvesting time).

Dietary Supplement

Lettuce without any eustress was assigned to each participant belonging to the control group which ate 100gr every day for 12 day

Other names: control lettuce

Experimental: Eustress group. To the intervention Eustress group was assigned the eustress lettuce.

Dietary Supplement

100gr of eustress lettuce were assigned to each participant belonging to the intervention group which ate 100 grams every day for a total of 12 days

Other names: Eustress Intervention group

Primary outcomes

  1. anthropometric measurement

    Time frame: 12 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/m^2).

  2. Bone metabolism markers

    Time frame: 12 days

    Parathyroid hormone (PTH) (ng/ml), calcitonin (ng/ml) will be assessed at baseline and after 12 days.

  3. Vitamin D

    Time frame: 12 days

    Vitamin D (microgram/L) will be assessed at baseline and after 12 days.

  4. blood markers

    Time frame: 12 days

    Calcium (mg/dL), Phosphate (mg/dL) will be assessed at baseline and after 12 days.

  5. Potassium

    Time frame: 12 days

    Potassium (mmol/L) will be assessed at baseline and after 12 days.

  6. Bone remodelling markers

    Time frame: 12 days

    markers of bone resorption CTX (μg/L) and bone formation osteocalcin (μg/L) will be assessed in serum at baseline and after 12 days.

  7. Iron

    Time frame: 12 days

    iron (μg/dL) will be assessed in serum at baseline and after 12 days.

  8. Ferritin

    Time frame: 12 days

    ferritin (ng/dL) will be assessed in serum at baseline and after 12 days.

  9. transferrin

    Time frame: 12 days

    transferrin (mg/dL) will be assessed in serum at baseline and after 12 days.

  10. % saturation of transferrin

    Time frame: 12 days

    % saturation of transferrin will be will be assessed in serum at baseline and after 12 days.

  11. markers of lipid metabolism

    Time frame: 12 days

    triglycerides , HDL, LDL, cholesterol (in mg/dL) will be measured in serum will be assessed at baseline and after 12 days.

  12. Insulin

    Time frame: 12 days

    insulin (mUI/L) will be measured in serum will be assessed at baseline and after 12 days.

  13. Glucose

    Time frame: 12 days

    Glucose (mg/dL) will be measured in serum will be assessed at baseline and after 12 days.

  14. markers of hepatic metabolism

    Time frame: 12 days

    Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) in U/l will be assessed in serum at baseline and after 12 days.

  15. Total protein (TP) and Albumin

    Time frame: 12 days

    Total protein (TP) and Albumin in g/L will be assessed in serum at baseline and after 12 days.

Secondary outcomes

  1. body composition

    Time frame: 12 days

    lean mass as percent of body weight and fat mass as percent of body weight will be will be assessed at baseline and after 12 days

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Analysis of the Potential Health Effects of Saline Eustress in Plant Food

Acronym: ESEPF

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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