Effects of Saline Eustress in Plant Food (ESEPF)

NCT06002672 | Completed

• 1 other identifier: Plant_Food_2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Diet

Outcome Measures

Primary Outcomes (15)

• anthropometric measurement

  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).

  12 days

• Bone metabolism markers

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

  12 days

• Vitamin D

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

  12 days

• blood markers

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

  12 days

• Potassium

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

  12 days

• Bone remodelling markers

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

  12 days

• Iron

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

  12 days

• Ferritin

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

  12 days

• transferrin

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

  12 days

• % saturation of transferrin

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

  12 days

• markers of lipid metabolism

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

  12 days

• Insulin

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

  12 days

• Glucose

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

  12 days

• markers of hepatic metabolism

  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.

  12 days

• Total protein (TP) and Albumin

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

  12 days

Secondary Outcomes (1)

• body composition

  12 days

Study Arms (2)

Control

PLACEBO COMPARATOR

group that consumed control lettuce

Dietary Supplement: 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).

Intervention

ACTIVE COMPARATOR

group that consumed eustress lettuce

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

Interventions

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

Also known as: control lettuce

Control

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

Also known as: Eustress Intervention group

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

NABbio, STEBICEF department

Palermo, 90128, Italy

Location

Related Publications (1)

• Ferrantelli V, Vasto S, Alongi A, Sabatino L, Baldassano D, Caldarella R, Gagliano R, Di Rosa L, Consentino BB, Vultaggio L, Baldassano S. Boosting plant food polyphenol concentration by saline eustress as supplement strategies for the prevention of metabolic syndrome: an example of randomized interventional trial in the adult population. Front Nutr. 2023 Dec 22;10:1288064. doi: 10.3389/fnut.2023.1288064. eCollection 2023.

  PMID: 38196756 DERIVED

MeSH Terms

Interventions

Soil; Water

Intervention Hierarchy (Ancestors)

Complex Mixtures; Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Sara Baldassano

  University of Palermo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Two groups that consumed lettuce. No differences in shape, size, colours of lettuce
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: control vs intervention

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 21, 2023
• Study Start: March 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: June 28, 2021
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)