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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • 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

    Recruiting

Other trials in United Kingdom

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.

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 groups in NCT06738329
Study groupRoleWhat they receive
Carrageenan gummyExperimentalGummies have been produced using carrageenan as a gelling agent. Each dose will consist of two carrageenan containing gummies
Receives: Other: Carrageenan gummy sweet
Prebiotic armExperimentalThe 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
PlaceboPlacebo comparatorAn 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.

  1. 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)
  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.

  1. First posted17 Dec 2024
  2. Study start1 Oct 2024
  3. Primary completion30 May 2025 (estimated)
  4. Study completion30 May 2025 (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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
99 participants (estimated)
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

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.

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