About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy individuals

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

Carrageenan gummy sweet
Other intervention
Gummy sweet containing carrageenan and agar as the gelling agents.
Carrageenan and inulin gummy sweet
Other intervention
Gummy sweet containing agar and carrageenan as gelling agents, with added inulin.
Placebo agar agar gummy
Other intervention
Gummy sweet containing agar as gelling agents.

Treatment groups

99 Participants

are divided into 3 treatment groups

Group A: Carrageenan gummyExperimental treatment 1 intervention

Group B: Prebiotic armExperimental treatment 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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)?

Time frame

4 week intervention period

Secondary outcomes

1

Assessing changes in gastrointestinal comfort post carrageenan-inulin consumption