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Investigating the Impact of the Seaweed Derived Food Additive, Carrageenan, on the Human Gut Microbiome

NCT ID: NCT06738329

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-05-30

Brief Summary

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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

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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

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Gut Microbiome Healthy Donors

Keywords

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Carrageenan Gut microbiome Gut health food additive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Carrageenan gummy

Gummies have been produced using carrageenan as a gelling agent. Each dose will consist of two carrageenan containing gummies

Group Type EXPERIMENTAL

Carrageenan gummy sweet

Intervention Type OTHER

Gummy sweet containing carrageenan and agar as the gelling agents.

Prebiotic arm

The prebiotic fibre, inulin, has been added into the carrageenan gummies. Each dose with consist of two gummy sweets.

Group Type EXPERIMENTAL

Carrageenan and inulin gummy sweet

Intervention Type OTHER

Gummy sweet containing agar and carrageenan as gelling agents, with added inulin.

Placebo

An alternative gelling agent, agar has been added to the gummy sweets as a placebo.

Group Type PLACEBO_COMPARATOR

Placebo agar agar gummy

Intervention Type OTHER

Gummy sweet containing agar as gelling agents.

Interventions

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Carrageenan gummy sweet

Gummy sweet containing carrageenan and agar as the gelling agents.

Intervention Type OTHER

Carrageenan and inulin gummy sweet

Gummy sweet containing agar and carrageenan as gelling agents, with added inulin.

Intervention Type OTHER

Placebo agar agar gummy

Gummy sweet containing agar as gelling agents.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy individuals

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium

UNKNOWN

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Hannah Thomas

Miss

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Reading

Reading, Reading, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Hannah Thomas, MSc Human Nutrition

Role: primary

Anisha Wijeyesekera, PhD

Role: backup

Hannah Thomas, MSc Human Nutrition

Role: backup

Anisha Wijeyesekera, PhD

Role: backup

Other Identifiers

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UREC24/21

Identifier Type: -

Identifier Source: org_study_id