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

NCT07097389 | Completed DMC

• 1 other identifier: UREC24/20
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cellobiose; preliminary in vivo human study

Outcome Measures

Primary Outcomes (2)

• Change in absolute abundance of faecal Bifidobacterium spp. and Lactobacillus spp.

  Absolute abundance of Bifidobacterium spp. and Lactobacillus spp. in faecal microbiota, determined by 16S rRNA gene sequencing (Illumina NGS sequencing) and FLOW-FISH for total bacterial counts

  Baseline (Day 0; Visit 1) to end of the intervention period (Day 28; Visit 5)

• Change in total faecal short-chain fatty acid concentration

  Sum of acetate, propionate, and butyrate concentrations in faecal samples, measured by GC-MS.

  Baseline (Day 0; Visit 1) to end of the intervention(Day 28; Visit 5)

Secondary Outcomes (2)

• Magnitude and pattern of overall gut-microbiota shifts from V1 to V5

  Baseline (V1) through end-point (V5) of the 28-day intervention

• Number of participants with Gastrointestinal Tolerability & Safety

  Days 1 through 28 of the intervention period

Other Outcomes (1)

• SCFA-Microbe Correlations & Other Genus Fold-Changes

  Baseline (V1) through end-point (V5) of the 28-day intervention.

Study Arms (3)

Maltodextrin

PLACEBO COMPARATOR

Participants receive 5 g/day for the first 7 days and 10 g/day maltodextrin for the rest of the 21 days as a non-prebiotic control.

Dietary Supplement: Maltodextrin (Placebo)

Orafti P95 (oligofructose P95)

ACTIVE COMPARATOR

Healthy adult volunteers will consume 5 g/day of Orafti P95 (oligofructose, Beneo GmbH) mixed in water for the first 7 days, and consume 10 g/day of Orafti P95 (oligofructose, Beneo GmbH) mixed in water for the rest of the 21 days.

Dietary Supplement: Oligofructose P95

Cellobiose

EXPERIMENTAL

Participants receive 5g/day for the first 7 days and 10 g/day cellobiose for 21 days.

Dietary Supplement: Cellobiose

Interventions

Cellobiose DIETARY_SUPPLEMENT

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.

Cellobiose

Oligofructose P95 DIETARY_SUPPLEMENT

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.

Orafti P95 (oligofructose P95)

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

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.

Maltodextrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18 years old and above
• Participants are willing to comply with the study instructions
• Participants have a stool frequency of at least 3 bowel movements per week
• Participants are healthy at the time of signing the consent form

You may not qualify if:

• Not pregnant or planning to be pregnant
• Previously or currently diagnosed gastrointestinal diseases and disorders that might affect the gut environment.
• Food allergies or intolerances
• Previously or currently diagnosed with cancer or taking a long-term medication.
• Use of medication (e.g, antibiotics, aspirin, proton pump inhibitors) influencing gastrointestinal function (8 weeks before intervention)
• Participants are currently involved or will be involved in another clinical or food study

Sponsors & Collaborators

• Manxi Huang: lead

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6DX, United Kingdom

Location

MeSH Terms

Interventions

Cellobiose; maltodextrin

Intervention Hierarchy (Ancestors)

Cellulose; Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Officials

• Bob Rastall

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate, Department of Food and Nutritional Sciences

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 31, 2025
• Study Start: July 31, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Six months after publication, with data available for up to five years thereafter.
• Access Criteria: The data will be available to qualified researchers who submit a reasonable research proposal and execute a data-use agreement.

Locations

GB (1)