ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem

NCT06231706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2025-02-26

No results posted yet for this study

Summary

The differences observed in host gut microbiome communities between health and disease states, and between different dietary patterns, has led to an increase in the use of dietary modulations to influence microbiome composition, both in research and in commercial contexts. Two particular groups of gut-active compounds include prebiotics (providing a direct source of nutrition that can stimulate host-beneficial microbiota as they are indigestible to the host) and probiotics (providing a direct source of live microorganisms that may potentially colonise the gut after reaching the large intestine, thus altering gut microbiome dynamics). Using a randomised controlled parallel trial design, the ZOE BIOME Study aims to investigate the efficacy of prebiotic and probiotic compounds in improving health outcomes including gut microbiome composition, gastrointestinal symptoms, and cardiometabolic markers of lipaemic, glycaemic and inflammatory status in a remote setting.

Further, consumption of high fibre supplements or food ingredients in combination with high carbohydrate meals has been shown to decrease the postprandial glycaemic response. To investigate the acute metabolic effects of prebiotic compounds , a randomised controlled crossover design postprandial study will be conducted. The ZOE BIOME Postprandial Study aims to investigate the efficacy of prebiotic compounds in improving acute postprandial glycaemic response, subjective feelings of hunger, satiety, mood, and subsequent eating behaviours.

Conditions

  • Gut Microbiome
  • Prebiotic
  • Probiotic
  • Postprandial Period

Interventions

OTHER

Prebiotic-like nut and seed mix

A mixture of nuts, seeds and other plant based ingredients.

OTHER

Bread Crouton

A commercially available bread crouton product.

DIETARY_SUPPLEMENT

Probiotic capsule

Contains the single strain Lactobacillus rhamnosus GG at 15 billion CFUs per capsule.

OTHER

White bread and low fat spread

Consists of 3 slices of bread (providing approx. 55-60g CHO; 3g fibre) + low fat spread (10-15g)

Sponsors & Collaborators

Principal Investigators

  • Sarah Berry, Dr · King's College London, ZOE Ltd

  • Tim Spector, Pr · King's College London, ZOE Ltd

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-26
Primary Completion
2024-05-30
Completion
2024-05-30

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT06231706 on ClinicalTrials.gov