In Vivo Human Study on Commercial Cellobiose as a Potential Prebiotic Candidate

Summary

The goal of this project is to investigate whether cellobiose, a type of sugar, has a beneficial effect on gut health when consumed by humans. Cellobiose will be obtained from spent coffee grounds through enzymatic modification, repurposing waste biomass for a potentially valuable purpose. The study will only focus on conducting in vivo human trials using a commercial form of cellobiose from Savanna Ingredients GmbH, which has recently been approved as a novel food by the EU (https://eur-lex.europa.eu/eli/reg\_impl/2023/943/oj)

We will also be testing two other commercial products: Orafti® P95, an oligofructose-based product from Beneo GmbH, and maltodextrin from Special Ingredients Limited. These products will be compared to evaluate their potential in promoting gut health by nourishing beneficial bacteria, The study will involve feeding these products to volunteers and observing their impact on gut health.

The key questions this project aims to address include:

* Does cellobiose, exhibit any gut health promoting effects in humans?
* How does cellobiose compare to other commercial prebiotic products, such as Orafti® P95, in terms of its effects on gut health?

To conduct the study, volunteers will be provided with the three different products to consume over a specified period. Their faecal samples will be collected at various points to assess changes in gut microbiota composition and other indicators of gut health. This will involve close monitoring of participants' health and adherence to ethical guidelines to ensure their safety and well-being throughout the study.

Overall, this project seeks to expand our understanding of the potential health benefits of cellobiose and other prebiotic carbohydrates. It aims to provide valuable insights into the role of these substances in promoting gut health.

Conditions

• Gut -Microbiota
• As a Preliminary Study, Healthy Population's Gut Microbiota is Studied to See if Cellobiose Supplementation is Altering the Microbial Community or Not

Interventions

DIETARY_SUPPLEMENT

Cellobiose

Cellobiose powder (Savanna Ingredients GmbH), 5 g per day and 10 g per day, mixed into \~200 mL water and taken orally with breakfast for the first 7 days and the rest of the 21 days.

DIETARY_SUPPLEMENT

Oligofructose P95

Oligofructose (Orafti® P95, Beneo GmbH), 5 g per day and 10 g per day, dissolved in \~200 mL water and taken orally with breakfast for the first 7 days and the rest of the 21 days.

DIETARY_SUPPLEMENT

Maltodextrin (Placebo)

Maltodextrin powder (Special Ingredients Limited), 5 g per day and 10 g per day, dissolved in \~200 mL water and taken orally with breakfast for the first 7 days and the rest of the 21 days.

Sponsors & Collaborators

• Manxi Huang

  lead OTHER

Principal Investigators

• Bob Rastall · University of Reading

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-31

Primary Completion

2025-04-30

Completion

2025-06-01

Countries

• United Kingdom

Study Locations