Healthy SubjectsSEAPRO01NCT06418763
The Effects of Fermented Brown Seaweed Intake on Glucose Metabolism and Gut Health
A study testing Baobab spread mixed with fermented brown seaweed and Baobab spread in people with Healthy Subjects, run by Aventure AB at 1 site in Sweden.
Trial summary
The aim of this randomised, controlled, cross-over study is to investigate whether the intake of fermented brown seaweed can lower postprandial blood glucose levels and influence the composition of the gut microbiota in 25 healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Baobab spread mixed with fermented brown seaweed and Baobab spread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 22 Apr 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females
- Age 20-40 years, at the time of signing the informed consent
- BMI 20-25 kg/m2
- Stable body weight (less than 5% difference during the last 3 months)
- Willing and able to give written informed consent for participating the study
- Willing to comply with all study procedures
Who cannot join
- Intake of antibiotics within 4 weeks prior to the start of the study
- Regular intake of probiotics and/or prebiotics within 4 weeks prior to the start of the study
- Tobacco use (smoking and/or snus)
- High alcohol intake: > 4 glasses daily
- Pregnancy or lactating
- Chronical disease (e.g., liver, kidney)
Show all 20Show fewer
- Diabetes
- Gastrointestinal disease (ulcerative colitis, Crohn's disease, irritable bowel syndrome)
- Heart disease (within the last 12 months)
- Inflammatory disease (e.g. asthma, GI inflammatory diseases) and auto-immune disease
- Treatment with corticosteroids of significant degree
- Psychological disease of significant degree
- Cancer of significant difference
- Gastric-bypass operation
- Operation planned during the study period
- Known gluten intolerance and/or lactose intolerance
- Having allergies to the food components of the study, mustard and seafoods
- Known gluten intolerance, lactose intolerance, milk protein allergy or other food allergies
- Irregular diet (i.e., not eating 3 main meals daily) or special diet (e.g. vegan, low-carb high-fat, 5-2)
- Investigator considers the subject unlikely to comply with the study procedures, restrictions, and requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Fermented Brown Seaweed Intake on Glucose Metabolism and Gut Health: a Short-term Study in Healthy Subjects
The aim of this randomised, controlled, cross-over study is to investigate whether the intake of fermented brown seaweed can lower postprandial blood glucose levels and influence the composition of the gut microbiota in 25 healthy volunteers. Well-being and gastrointestinal symptoms as well as sensory properties of the products will also be evaluated using questionnaires.
At the screening visit, the subjects will be informed about the study procedures and inclusion/exclusion criteria will be checked. Informed consent will be signed by each subject before participating in the study. The participants will consume the active and control product, respectively, for 5 days with a 14-day wash-out period in between. Capillary blood samples will be drawn for glucose measurement at the first day of each 5-day intervention period. Faecal samples will be collected before and after each 5-day intervention period to analyse changes in gut microbial composition.
Read the detailed description
Fermented seaweed is a sustainable food with increasing interest as an ingredient of a plant-based diet. Plant-based diets are gaining popularity both because of their health benefits and low-carbon footprint. Seaweed is a rich source of minerals, polyphenols and dietary fibres like xylans, carrageenan, fucoidan, laminarin and alginate. These bioactive compounds have been shown to exert positive effects on metabolic parameters, such as blood glucose and insulin, blood lipid profile and inflammatory markers and could therefore help in the prevention of cardiovascular diseases. Besides possible health benefits, fermentation of seaweed can offer potential advantages such as improved food safety and shelf life of non-dried seaweed as well as improved sensory properties.
The project aims to investigate the effects of fermented brown seaweed (Alaria Esculenta, also known as winged kelp) on glucose metabolism and its prebiotic potential in humans. A short-term pilot study (5-day intake period) will be conducted in young healthy subjects.
Twenty-five healthy subjects will be recruited to this study. This study will be a randomised controlled cross-over study where all participants will consume the test product and the control product for 5 days. In between each 5-day intervention period, there will be a wash-out period of 2 weeks.
At the first day of each 5-day intake period, the subjects have to come to the study centre in the morning in a fasting state. A test meal with the active product or control product containing each 50g of total carbohydrates will be served. Blood samples (finger-pricking) will be taken at fasting state (0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min. The participants will then consume the product daily for 5 days at a dose of 2x 15g baobab with or without (control) 15% of the fermented seaweed. The product will be available as a spread in packages of 15g. After a wash-out period of 2 weeks, the participants will take the other product (cross-over design).
Faecal samples will be collected before and at the end of each 5-day intervention period. The questionnaire about well-being and gastrointestinal symptoms will be filled at home daily during each 5-day intervention. Also, a sensory questionnaire will be filled in at day 1 and 5 of intervention period.
- Conditions
- Healthy Subjects
- Being tested
- Baobab spread mixed with fermented brown seaweed, Baobab spread
- Keywords
- seaweed, blood glucose, gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baobab spread mixed with fermented brown seaweedDietary supplement
5-day intake period
Baobab spreadDietary supplement
5-day intake period
| Study group | Role | What they receive |
|---|---|---|
| Baobab spread mixed with fermented seaweed | Active comparator | Daily intake 2x 15g The product is available as a spread and will be consumed with bread Receives: Dietary Supplement: Baobab spread mixed with fermented brown seaweed |
| Baobab spread | Placebo comparator | Daily intake 2x 15g The product is available as a spread and will be consumed with bread Receives: Dietary Supplement: Baobab spread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose
iAUC 0- 180 minutes
Measured: 0- 180 minutes (after intake of the study product)
Secondary outcomes (1)
Gut microbiota
Total and Lactobacillus specific bacterial communities will be measured in fecal samples
Measured: Before and immediately after each 5-day intake period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start22 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aventure AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University, Carbiotix AB
- Responsible party
- Sponsor
- Investigators
- Lieselotte Cloetens, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418763
- Sponsor's protocol ID
- SEAPRO01
- Acronym
- SEAPRO01
- Status last verified
- Jul 2024
- First submitted
- 23 Apr 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fermented Brown Seaweed Intake on Glucose Metabolism and Gut Health: a Short-term Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06418763
- Acronym / sponsor ID
- SEAPRO01 / SEAPRO01
- Conditions
- Healthy Subjects
- Keywords
- seaweed, blood glucose, gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aventure ABIndustry (pharma, biotech, devices)
- Collaborators
- Lund University, Carbiotix AB
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 May 2024 (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 aim of this randomised, controlled, cross-over study is to investigate whether the intake of fermented brown seaweed can lower postprandial blood glucose levels and influence the composition of the gut microbiota in 25 healthy volunteers. Well-being and gastrointestinal symptoms as well as sensory properties of the products will also be evaluated using questionnaires.
At the screening visit, the subjects will be informed about the study procedures and inclusion/exclusion criteria will be checked. Informed consent will be signed by each subject before participating in the study. The participants will consume the active and control product, respectively, for 5 days with a 14-day wash-out period in between. Capillary blood samples will be drawn for glucose measurement at the first day of each 5-day intervention period. Faecal samples will be collected before and after each 5-day intervention period to analyse changes in gut microbial composition.
Detailed description
Fermented seaweed is a sustainable food with increasing interest as an ingredient of a plant-based diet. Plant-based diets are gaining popularity both because of their health benefits and low-carbon footprint. Seaweed is a rich source of minerals, polyphenols and dietary fibres like xylans, carrageenan, fucoidan, laminarin and alginate. These bioactive compounds have been shown to exert positive effects on metabolic parameters, such as blood glucose and insulin, blood lipid profile and inflammatory markers and could therefore help in the prevention of cardiovascular diseases. Besides possible health benefits, fermentation of seaweed can offer potential advantages such as improved food safety and shelf life of non-dried seaweed as well as improved sensory properties.
The project aims to investigate the effects of fermented brown seaweed (Alaria Esculenta, also known as winged kelp) on glucose metabolism and its prebiotic potential in humans. A short-term pilot study (5-day intake period) will be conducted in young healthy subjects.
Twenty-five healthy subjects will be recruited to this study. This study will be a randomised controlled cross-over study where all participants will consume the test product and the control product for 5 days. In between each 5-day intervention period, there will be a wash-out period of 2 weeks.
At the first day of each 5-day intake period, the subjects have to come to the study centre in the morning in a fasting state. A test meal with the active product or control product containing each 50g of total carbohydrates will be served. Blood samples (finger-pricking) will be taken at fasting state (0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min. The participants will then consume the product daily for 5 days at a dose of 2x 15g baobab with or without (control) 15% of the fermented seaweed. The product will be available as a spread in packages of 15g. After a wash-out period of 2 weeks, the participants will take the other product (cross-over design).
Faecal samples will be collected before and at the end of each 5-day intervention period. The questionnaire about well-being and gastrointestinal symptoms will be filled at home daily during each 5-day intervention. Also, a sensory questionnaire will be filled in at day 1 and 5 of intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baobab spread mixed with fermented seaweed | Active comparator | Dietary Supplement: Baobab spread mixed with fermented brown seaweedDaily intake 2x 15g The product is available as a spread and will be consumed with bread |
| Baobab spread | Placebo comparator | Dietary Supplement: Baobab spreadDaily intake 2x 15g The product is available as a spread and will be consumed with bread |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males and females
- Age 20-40 years, at the time of signing the informed consent
- BMI 20-25 kg/m2
- Stable body weight (less than 5% difference during the last 3 months)
- Willing and able to give written informed consent for participating the study
Key exclusion criteria (20 listed)
- Intake of antibiotics within 4 weeks prior to the start of the study
- Regular intake of probiotics and/or prebiotics within 4 weeks prior to the start of the study
- Tobacco use (smoking and/or snus)
- High alcohol intake: > 4 glasses daily
- Pregnancy or lactating
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 |
|---|---|---|
| Baobab spread mixed with fermented brown seaweed5-day intake period | Dietary supplement | Baobab spread mixed with fermented seaweed |
| Baobab spread5-day intake period | Dietary supplement | Baobab spread |
Primary outcome
Postprandial blood glucose
Time frame: 0- 180 minutes (after intake of the study product)
iAUC 0- 180 minutes
1 secondary outcome
Gut microbiota
Time frame: Before and immediately after each 5-day intake period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Lieselotte Cloetens principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baobab spread mixed with fermented brown seaweed and Baobab spread in people with Healthy Subjects, run by Aventure AB at 1 site in Sweden.
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 6 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 31 Jul 2024. 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 Sweden. 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?
Results are not available in the source record.
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?
Postprandial blood glucose (time frame: 0- 180 minutes (after intake of the study product)). 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 31 Jul 2024.