Bioavailability of Phlorotannins and Carotenoids Following the Intake of Crackers Fortified With Seaweed

NCT07508735 | Active Not Recruiting

• 2 other identifiers: BIO-ALGACOOPB24080
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the bioavailability of phlorotannins and carotenoids from the seaweed Himanthalia elongata in healthy individuals after the consumption of a cracker fortified with this plant species. The study consists of an acute, blinded, randomized, controlled, crossover trial in which each participant consumes both the fortified cracker and a control cracker without seaweed. This design allows the comparison of the bioavailability of these compounds when incorporated into a bakery-based food matrix.

Conditions

Bioavailability Heathy Volunteers; Bioavailability and AUC

Keywords

carotenoids; absortion; Cmax; phlorotannins; bioavailability

Outcome Measures

Primary Outcomes (1)

• Targeted metabolic analysis of phlorotannins in blood/urine samples

  Targeted metabolomic analysis of phlorotannins in plasma and urine samples will be conducted using HPLC-QTOF-MS. Quantification of the concentration (μM) will be carried out employing authentic commercial standards, ensuring accurate and reliable measurement of target compounds.

  2 moths

Secondary Outcomes (5)

• Targeted metabolic analysis of carotenoids in blood/urine samples.

  2 months

• Maximum concentration in blood of metabolites

  2 month

• Area under the curve (AUC) of metabolites in blood samples

  2 moths

• Time to maximum concentration (Tmax)

  2 month

• Urinary excretion percentage of metabolites

  2 months

Study Arms (2)

Seaweed cracker

EXPERIMENTAL

Rice flour, wheat flour, cornstarch, Himanthalia elongata (0.94 g), salt, sesame, mannitol, baking powder, olive oil.

Other: Seaweed cracker

Control cracker

PLACEBO COMPARATOR

Rice flour, wheat flour, cornstarch, salt, sesame, mannitol, baking powder, olive oil

Other: Control cracker

Interventions

Seaweed cracker OTHER

Four crackers (20 g) fortified with seaweed Himanthalia elongata

Seaweed cracker

Control cracker OTHER

Four crackers (20 g) without seaweed in its composition

Control cracker

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index: 18-30 Kg/m2

You may not qualify if:

• Following a vegetarian diet
• Being pregnant
• Suffering from digestive diseases (such as irritable bowel syndrome, gastrointestinal ulcers, etc.)
• Having a history of hypersensitivity or allergies to components of the study foods
• Following any medication regimen
• Currently taking or having recently taken antibiotics
• Having donated blood within the three months prior to the study

Sponsors & Collaborators

• National Research Council, Spain: lead

Study Sites (1)

Institute of Food Science, Technology and Nutrition, Spanish National Research Council (ICTAN-CSIC)

Madrid, Madrid, 28040, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Researcher

Model Details: Acute and controlled

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: April 2, 2026
• Study Start: March 1, 2026
• Primary Completion: March 16, 2026
• Study Completion: June 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

ES (1)