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Bioavailability Heathy VolunteersBIO-ALGANCT07508735

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

A study testing Seaweed cracker in people with Bioavailability Heathy Volunteers and Bioavailability and AUC, run by National Research Council, Spain at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Seaweed cracker
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteSpain
Study dates
1 Mar 2026to 1 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body mass index: 18-30 Kg/m2

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Institute of Food Science, Technology and Nutrition, Spanish National Research Council (ICTAN-CSIC)

    Madrid, Madrid, 28040

Other trials in Spain

About this study

Official title: Evaluation of the Bioavailability of Phlorotannins and Carotenoids Following the Intake of Crackers Fortified With Himanthalia Elongata

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.

Read the detailed description

The BIO-ALGA study is a nutritional intervention designed to evaluate the bioavailability in humans of bioactive compounds present in the brown seaweed Himanthalia elongata, specifically phlorotannins and carotenoids. These compounds have attracted growing interest in the fields of nutrition and functional foods due to their potential antioxidant, anti-inflammatory, and metabolic regulatory properties. Marine macroalgae, and particularly Himanthalia elongata, are recognized as a valuable source of these compounds, in addition to providing dietary fiber, minerals, and other nutrients that may contribute to the prevention of chronic diseases such as obesity, type 2 diabetes, and cardiovascular disorders. However, for these compounds to exert physiological effects in the human body, they must be absorbed during digestion and reach the systemic circulation. Therefore, studying their bioavailability under real consumption conditions in humans is essential.

To address this objective, the study is designed as an acute, randomized, controlled, crossover, and blinded nutritional intervention conducted in healthy adults. Each participant will consume four functional cracker (approx. 20 g) on separate days: one enriched with Himanthalia elongata and another control cracker with identical formulation but without seaweed. The two interventions will be separated by a washout period of at least fifteen days to avoid carryover effects. The expected sample size is at least ten participants, ideally twelve, with balanced representation of men and women. Eligible participants will be healthy adults aged between 18 and 45 years with a body mass index between 18 and 30 kg/m². Exclusion criteria include, digestive diseases, allergies to the ingredients used in the study, current medication or supplement use, hormonal treatments, recent antibiotic consumption, or pregnancy.

The test product consists of four functional cracker weighing approximately 20 g and containing 1 g of freeze-dried Himanthalia elongata powder. This amount ensures the presence of the target bioactive compounds while remaining within safe dietary limits for iodine intake. The formulation includes rice flour, cornstarch, wheat flour, sesame, baking powder, egg and water. A little olive oil was used to enhance the absorption of carotenoids, such as fucoxanthin. Mannitol is used as a sweetener to provide sweetness without substantially increasing caloric content. The placebo bar has the same composition but does not contain seaweed, allowing direct comparison of the absorption of bioactive compounds delivered through the food matrix.

During the seven days prior to each intervention and throughout the study period, participants will be instructed to avoid the consumption of seaweed products. Additionally, they will complete a three-day dietary record before each intervention. On the intervention day, volunteers will attend the Human Nutrition Unit of the Institute of Food Science, Technology and Nutrition (ICTAN-CSIC) after an overnight fast of at least ten hours. A venous cannula will be inserted to allow repeated blood sampling, after which participants will consume the assigned cracker and remain at the research facility for the entire study day under the supervision of the research team. Throughout the day they will receive a standardized polyphenol-free diet to minimize interference with the analytical detection of metabolites derived from the seaweed.

Blood samples will be collected before intake and at multiple postprandial time points (0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 19, and 24 hours) in order to evaluate the plasma kinetics of the absorbed compounds and their metabolites. Approximately 9 mL of blood will be collected at each time point, resulting in a total volume of 99 mL per intervention. Plasma will be separated by centrifugation and stored at -80 °C until analysis. In parallel, urine samples will be collected at defined intervals (-2 to 0 h, 0-3 h, 3-6 h, 6-9 h, and 9-24 h) to assess the urinary excretion of metabolites derived from the bioactive compounds present in the seaweed.

The collected biological samples will be analyzed using high-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry with electrospray ionization (HPLC-ESI-QTOF). Targeted metabolomic approaches will be applied to identify and quantify metabolites derived from phlorotannins and carotenoids present in Himanthalia elongata. Based on plasma concentration profiles and urinary excretion patterns, nutritional kinetic parameters such as maximum concentration (Cmax), time to reach maximum concentration (Tmax), and the area under the concentration-time curve (AUC) will be calculated, as well as the proportion of excreted metabolites relative to the ingested dose. This analytical strategy will allow the characterization of the real bioavailability of these compounds under physiological conditions and the identification of potential biomarkers of seaweed consumption.

The study poses minimal risk to participants, mainly limited to mild and transient discomfort associated with blood sampling. The ingredients used in the functional crackers have been carefully selected to ensure food safety and to maintain micronutrient intake, including iodine, within recommended limits. Although the study does not have a direct therapeutic objective, its results are expected to expand current knowledge about the metabolism and bioavailability of seaweed-derived bioactive compounds in humans and to provide scientific evidence supporting the development of functional foods incorporating marine algae with potential health benefits.

Being tested
Seaweed cracker, Control cracker
Keywords
carotenoids, absortion, Cmax, phlorotannins, bioavailability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seaweed crackerOther

    Four crackers (20 g) fortified with seaweed Himanthalia elongata

  • Control crackerOther

    Four crackers (20 g) without seaweed in its composition

Study groups in NCT07508735
Study groupRoleWhat they receive
Seaweed crackerExperimentalRice flour, wheat flour, cornstarch, Himanthalia elongata (0.94 g), salt, sesame, mannitol, baking powder, olive oil.
Receives: Other: Seaweed cracker
Control crackerPlacebo comparatorRice flour, wheat flour, cornstarch, salt, sesame, mannitol, baking powder, olive oil
Receives: Other: Control cracker

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 moths

Secondary outcomes (5)
  1. Targeted metabolic analysis of carotenoids in blood/urine samples.

    Targeted metabolomic analysis of carotenoids 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.

    Measured: 2 months

  2. Maximum concentration in blood of metabolites

    Calculation of the maximum concentration before cracker intake

    Measured: 2 month

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

    Metabolite concentrations will be measured at different time points in order to calculate the area under the concentration-time curve.

    Measured: 2 moths

  4. Time to maximum concentration (Tmax)

    The time required to reach the maximum concentration of the metabolites (Tmax).

    Measured: 2 month

  5. Urinary excretion percentage of metabolites

    Urinary excretion percentage of metabolites

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study start1 Mar 2026
  3. Primary completion16 Mar 2026
  4. Study completion1 Jun 2026 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Acute and controlled
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508735
Sponsor's protocol ID
BIO-ALGA
Other IDs
COOPB24080
Acronym
BIO-ALGA
Status last verified
Mar 2026
First submitted
5 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data will be available in open data repositories and may be accessed once the study results are published.

Questions about this trial

What is this clinical trial studying?

A study testing Seaweed cracker in people with Bioavailability Heathy Volunteers and Bioavailability and AUC, run by National Research Council, Spain at 1 site in Spain.

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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. 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 Spain. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Targeted metabolic analysis of phlorotannins in blood/urine samples (time frame: 2 moths). 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 2 Apr 2026.

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