Gut MicrobiomeNCT06738329
Investigating the Impact of the Seaweed Derived Food Additive, Carrageenan, on the Human Gut Microbiome
A study testing Carrageenan gummy sweet and Carrageenan and inulin gummy sweet in people with Gut Microbiome and Healthy Donors, run by University of Reading at 1 site in United Kingdom.
Trial summary
The goal of this study is to investigate whether a seaweed derived food additive, carrageenan, has an impact on the human gut microbiome in vivo. The primary purpose is to assess whether consumption of a carrageenan containing product for 4 weeks can alter the bacterial composition of the gut microbiome in healthy… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Healthy Donors
- What is being tested?
- Carrageenan gummy sweet and Carrageenan and inulin gummy sweet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2024to 30 May 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
Who cannot join
- Prescribed antibiotics in the last 3 months
- Individuals with any gut disorders such as IBS or IBD
- individuals with any food allergies or intolerances
- Individuals who regularly consume pre or probiotics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Reading
Reading, Reading, rg66ah
Hannah Thomas, MSc Human Nutrition, 07528804446, hannah.thomas@pgr.reading.ac.uk
Anisha Wijeyesekera, PhD, +44 (0) 118 378 6648, a.wijeyesekera@reading.ac.uk
About this study
The goal of this study is to investigate whether a seaweed derived food additive, carrageenan, has an impact on the human gut microbiome in vivo. The primary purpose is to assess whether consumption of a carrageenan containing product for 4 weeks can alter the bacterial composition of the gut microbiome in healthy individuals and whether the addition of a prebiotic fibre, inulin, to the product has an enhanced beneficial impact of the gut composition. The main questions to answer are:
Does the consumption of a confectionary item containing carrageenan and inulin lead to a positive impact on the faecal microbial community when compared to the confectionary item containing no carrageenan and no inulin (placebo)? Participants will be asked to consume 2 gummy sweets for 4 week period and provide stool and urine samples on 3 occasions over a 9 week period.
Does the consumption of a confectionary item containing carrageenan and inulin improve gastrointestinal comfort measured using overall SHS-GI score when compared to baseline measurements recorded during run in period?
Read the detailed description
Carrageenan is a frequently used food additive within the food industry. It acts as a gelling agent and thickener and is often used as a vegan alternative to gelatine. You will often see it on food labels as E407 or E407a. As a type of carbohydrate resistant to human digestion, the question has been posed as to whether carrageenan can be utilised by the gut microbiota (the community of microorganisms residing in the human gut). As the confectionary market remains a big part of daily life for many, having sweets that have a positive impact on the gut microbiota could be a step forward in promoting healthier snack choices. We have conducted lab-based experiments which have shown that carrageenan can be used by a number of gut microbial species, both beneficial and undesirable. We ascertained that consumption of carrageenan in low amounts in conjunction with prebiotics (dietary substrates selectively utilised by beneficial gut microorganisms which have a health benefit) can mitigate the growth of undesirable microbes, and overall have an enhanced beneficial effect on the microbial composition by promoting the growth on beneficial gut bacteria. This study aims to assess if these positive microbial changes can also be observed in humans, by conducting a human trial. We will adopt a randomised, double-blind parallel study design in which participants are either given 1) a carrageenan (0.167g) containing confectionary item 2) a carrageenan and inulin (5g) containing confectionary item or 3) a confectionary item containing an alternative gelling agent (control) to consume daily for 4 weeks. The dosage of carrageenan is comparable to what is found in commercially available sweets. The dosage of inulin is comparable to what previous studies found had a positive impact on the gut microbiome. Participants will be screened for eligibility prior to the study and given time to consider their participation. Once consent has been gained, participants will be asked to complete a 24 hour recall on 3 days during a 1 week run-in period (period prior to consuming the intervention/placebo). Participants will be asked to donate a stool and urine sample on the first day of the study. They will be asked to complete a Bristol stool chart daily (to monitor bowel habits) and a Short Health Scale for GastroIntestinal symptoms (SHS-GI) questionnaire daily (to monitor gastrointestinal symptoms) and to complete a second 3 -day dietary recall at the end of the 4 week intervention. On the last day of the 4 week intervention participants will be asked to give a second stool and urine sample. The participants will also be asked to give a third sample after a 4 week washout period (a period where participants will not consume any intervention). The purpose of this washout period it to assess whether any changes to the gut microbiota are reversed after 4 weeks. The collected stool and urine samples will be analysed using microbial and metabolic profiling to identify differences in gut microbiota composition and function. Participants will be allocated unique ID codes and will be given the opportunity to withdraw at any time during the study without explanation.
- Conditions
- Gut Microbiome, Healthy Donors
- Being tested
- Carrageenan gummy sweet, Carrageenan and inulin gummy sweet, Placebo agar agar gummy
- Keywords
- Carrageenan, Gut microbiome, Gut health, food additive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carrageenan gummy sweetOther
Gummy sweet containing carrageenan and agar as the gelling agents.
Carrageenan and inulin gummy sweetOther
Gummy sweet containing agar and carrageenan as gelling agents, with added inulin.
Placebo agar agar gummyOther
Gummy sweet containing agar as gelling agents.
| Study group | Role | What they receive |
|---|---|---|
| Carrageenan gummy | Experimental | Gummies have been produced using carrageenan as a gelling agent. Each dose will consist of two carrageenan containing gummies Receives: Other: Carrageenan gummy sweet |
| Prebiotic arm | Experimental | The prebiotic fibre, inulin, has been added into the carrageenan gummies. Each dose with consist of two gummy sweets. Receives: Other: Carrageenan and inulin gummy sweet |
| Placebo | Placebo comparator | An alternative gelling agent, agar has been added to the gummy sweets as a placebo. Receives: Other: Placebo agar agar gummy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing changes in microbial community post consumption of a carrageenan-inulin gummy.
Does the consumption of a confectionary item containing carrageenan and inulin lead to a positive impact on the faecal microbial community when compared to the confectionary item containing no carrageenan and no inulin (placebo)?
Measured: 4 week intervention period
Secondary outcomes (1)
Assessing changes in gastrointestinal comfort post carrageenan-inulin consumption
Does the consumption of a confectionary item containing carrageenan and inulin improve gastrointestinal comfort measured using overall SHS-GI score when compared to baseline measurements recorded during run in period?
Measured: 4 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Oct 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium
- Responsible party
- Principal investigator, Hannah Thomas, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738329
- Sponsor's protocol ID
- UREC24/21
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of the Seaweed Derived Food Additive, Carrageenan, on the Human Gut Microbiome
- ClinicalTrials.gov ID
- NCT06738329
- Acronym / sponsor ID
- UREC24/21
- Conditions
- Gut Microbiome, Healthy Donors
- Keywords
- Carrageenan, Gut microbiome, Gut health, food additive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 17 Dec 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 goal of this study is to investigate whether a seaweed derived food additive, carrageenan, has an impact on the human gut microbiome in vivo. The primary purpose is to assess whether consumption of a carrageenan containing product for 4 weeks can alter the bacterial composition of the gut microbiome in healthy individuals and whether the addition of a prebiotic fibre, inulin, to the product has an enhanced beneficial impact of the gut composition. The main questions to answer are:
Does the consumption of a confectionary item containing carrageenan and inulin lead to a positive impact on the faecal microbial community when compared to the confectionary item containing no carrageenan and no inulin (placebo)? Participants will be asked to consume 2 gummy sweets for 4 week period and provide stool and urine samples on 3 occasions over a 9 week period.
Does the consumption of a confectionary item containing carrageenan and inulin improve gastrointestinal comfort measured using overall SHS-GI score when compared to baseline measurements recorded during run in period?
Detailed description
Carrageenan is a frequently used food additive within the food industry. It acts as a gelling agent and thickener and is often used as a vegan alternative to gelatine. You will often see it on food labels as E407 or E407a. As a type of carbohydrate resistant to human digestion, the question has been posed as to whether carrageenan can be utilised by the gut microbiota (the community of microorganisms residing in the human gut). As the confectionary market remains a big part of daily life for many, having sweets that have a positive impact on the gut microbiota could be a step forward in promoting healthier snack choices. We have conducted lab-based experiments which have shown that carrageenan can be used by a number of gut microbial species, both beneficial and undesirable. We ascertained that consumption of carrageenan in low amounts in conjunction with prebiotics (dietary substrates selectively utilised by beneficial gut microorganisms which have a health benefit) can mitigate the growth of undesirable microbes, and overall have an enhanced beneficial effect on the microbial composition by promoting the growth on beneficial gut bacteria. This study aims to assess if these positive microbial changes can also be observed in humans, by conducting a human trial. We will adopt a randomised, double-blind parallel study design in which participants are either given 1) a carrageenan (0.167g) containing confectionary item 2) a carrageenan and inulin (5g) containing confectionary item or 3) a confectionary item containing an alternative gelling agent (control) to consume daily for 4 weeks. The dosage of carrageenan is comparable to what is found in commercially available sweets. The dosage of inulin is comparable to what previous studies found had a positive impact on the gut microbiome. Participants will be screened for eligibility prior to the study and given time to consider their participation. Once consent has been gained, participants will be asked to complete a 24 hour recall on 3 days during a 1 week run-in period (period prior to consuming the intervention/placebo). Participants will be asked to donate a stool and urine sample on the first day of the study. They will be asked to complete a Bristol stool chart daily (to monitor bowel habits) and a Short Health Scale for GastroIntestinal symptoms (SHS-GI) questionnaire daily (to monitor gastrointestinal symptoms) and to complete a second 3 -day dietary recall at the end of the 4 week intervention. On the last day of the 4 week intervention participants will be asked to give a second stool and urine sample. The participants will also be asked to give a third sample after a 4 week washout period (a period where participants will not consume any intervention). The purpose of this washout period it to assess whether any changes to the gut microbiota are reversed after 4 weeks. The collected stool and urine samples will be analysed using microbial and metabolic profiling to identify differences in gut microbiota composition and function. Participants will be allocated unique ID codes and will be given the opportunity to withdraw at any time during the study without explanation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carrageenan gummy | Experimental | Other: Carrageenan gummy sweetGummies have been produced using carrageenan as a gelling agent. Each dose will consist of two carrageenan containing gummies |
| Prebiotic arm | Experimental | Other: Carrageenan and inulin gummy sweetThe prebiotic fibre, inulin, has been added into the carrageenan gummies. Each dose with consist of two gummy sweets. |
| Placebo | Placebo comparator | Other: Placebo agar agar gummyAn alternative gelling agent, agar has been added to the gummy sweets as a placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals
Key exclusion criteria (4 listed)
- Prescribed antibiotics in the last 3 months
- Individuals with any gut disorders such as IBS or IBD
- individuals with any food allergies or intolerances
- Individuals who regularly consume pre or probiotics
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 |
|---|---|---|
| Carrageenan gummy sweetGummy sweet containing carrageenan and agar as the gelling agents. | Other | Carrageenan gummy |
| Carrageenan and inulin gummy sweetGummy sweet containing agar and carrageenan as gelling agents, with added inulin. | Other | Prebiotic arm |
| Placebo agar agar gummyGummy sweet containing agar as gelling agents. | Other | Placebo |
Primary outcome
Assessing changes in microbial community post consumption of a carrageenan-inulin gummy.
Time frame: 4 week intervention period
Does the consumption of a confectionary item containing carrageenan and inulin lead to a positive impact on the faecal microbial community when compared to the confectionary item containing no carrageenan and no inulin (placebo)?
1 secondary outcome
Assessing changes in gastrointestinal comfort post carrageenan-inulin consumption
Time frame: 4 week intervention period
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 17 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carrageenan gummy sweet and Carrageenan and inulin gummy sweet in people with Gut Microbiome and Healthy Donors, run by University of Reading at 1 site in United Kingdom.
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 4 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: looking for participants now, as of the sponsor's last update on 17 Dec 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 United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing changes in microbial community post consumption of a carrageenan-inulin gummy. (time frame: 4 week intervention period). 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 17 Dec 2024.