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

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?

NCT Number	NCT06738329
Lead Sponsor	University of Reading Collaborators: Cargill R&D Centre Europe, Havenstraat 84, 1800 Vilvoorde, Belgium
Conditions	Gut Microbiome, Healthy Donors
Enrollment	99 participants
Start Date	2024-10-01
Primary Completion	2025-05-30 (estimated)
Study Completion	2025-05-30 (estimated)
Updated on ClinicalTrials.gov	2024-12-17