ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem
NCT06231706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 399
Last updated 2025-02-26
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
-
Zoe Global Limited
collaborator OTHER - lead OTHER
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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