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

NCT06738329 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-12-17

No results posted yet for this study

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

Interventions

OTHER

Carrageenan gummy sweet

Gummy sweet containing carrageenan and agar as the gelling agents.

OTHER

Carrageenan and inulin gummy sweet

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

OTHER

Placebo agar agar gummy

Gummy sweet containing agar as gelling agents.

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • University of Reading

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-05-30
Completion
2025-05-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06738329 on ClinicalTrials.gov