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

NCT06738329 | Recruiting

• 1 other identifier: UREC24/21
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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 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?

Conditions

Gut Microbiome; Healthy Donors

Keywords

Carrageenan; Gut microbiome; Gut health; food additive

Outcome Measures

Primary Outcomes (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)?

  4 week intervention period

Secondary Outcomes (1)

• Assessing changes in gastrointestinal comfort post carrageenan-inulin consumption

  4 week intervention period

Study Arms (3)

Carrageenan gummy

EXPERIMENTAL

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

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.

Other: Carrageenan and inulin gummy sweet

Placebo

PLACEBO COMPARATOR

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

Other: Placebo agar agar gummy

Interventions

Carrageenan gummy sweet OTHER

Gummy sweet containing carrageenan and agar as the gelling agents.

Carrageenan gummy

Carrageenan and inulin gummy sweet OTHER

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

Prebiotic arm

Placebo agar agar gummy OTHER

Gummy sweet containing agar as gelling agents.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium: collaborator

Study Sites (1)

University of Reading

Reading, Reading, rg66ah, United Kingdom

RECRUITING

MeSH Terms

Interventions

Carrageenan

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miss

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: October 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

GB (1)