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.
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
- Conditions the study is for
- Bioavailability Heathy Volunteers, Bioavailability and AUC
- 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
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 group | Role | What they receive |
|---|---|---|
| Seaweed cracker | Experimental | Rice flour, wheat flour, cornstarch, Himanthalia elongata (0.94 g), salt, sesame, mannitol, baking powder, olive oil. Receives: Other: Seaweed cracker |
| Control cracker | Placebo comparator | Rice 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.
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)
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
Maximum concentration in blood of metabolites
Calculation of the maximum concentration before cracker intake
Measured: 2 month
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
Time to maximum concentration (Tmax)
The time required to reach the maximum concentration of the metabolites (Tmax).
Measured: 2 month
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.
- First posted2 Apr 2026
- Study start1 Mar 2026
- Primary completion16 Mar 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability Heathy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Acute and controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Responsible party
- Principal investigator, María Raquel Mateos Briz, National Research Council, Spain
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bioavailability of Phlorotannins and Carotenoids Following the Intake of Crackers Fortified With Himanthalia Elongata
- ClinicalTrials.gov ID
- NCT07508735
- Acronym / sponsor ID
- BIO-ALGA / BIO-ALGA
- Keywords
- carotenoids, absortion, Cmax, phlorotannins, bioavailability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Research Council, SpainOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 Apr 2026 (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 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Acute and controlled
| Arm | Type | Receives |
|---|---|---|
| Seaweed cracker | Experimental | Other: Seaweed crackerRice flour, wheat flour, cornstarch, Himanthalia elongata (0.94 g), salt, sesame, mannitol, baking powder, olive oil. |
| Control cracker | Placebo comparator | Other: Control crackerRice flour, wheat flour, cornstarch, salt, sesame, mannitol, baking powder, olive oil |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index: 18-30 Kg/m2
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Seaweed crackerFour crackers (20 g) fortified with seaweed Himanthalia elongata | Other | Seaweed cracker |
| Control crackerFour crackers (20 g) without seaweed in its composition | Other | Control cracker |
Primary outcome
Targeted metabolic analysis of phlorotannins in blood/urine samples
Time frame: 2 moths
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.
5 secondary outcomes
Targeted metabolic analysis of carotenoids in blood/urine samples.
Time frame: 2 months
Maximum concentration in blood of metabolites
Time frame: 2 month
Area under the curve (AUC) of metabolites in blood samples
Time frame: 2 moths
Time to maximum concentration (Tmax)
Time frame: 2 month
Urinary excretion percentage of metabolites
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data will be available in open data repositories and may be accessed once the study results are published.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.