ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem

NCT06231706 | Completed

• 1 other identifier: BIOME
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gut Microbiome; Hunger; Mood; Energy; Postprandial

Outcome Measures

Primary Outcomes (2)

• Phase 1: Microbiome Composition

  The change in relative abundance of microbiome species from baseline to endpoint, derived from metagenomic analysis of stool samples.

  Baseline and 6 weeks

• Phase 2: Peak postprandial interstitial glucose concentration (C-Max)

  Difference in C-Max between intervention and control meals.

  Within 3 hours post test meal consumption

Secondary Outcomes (22)

• Phase 1: Lipid blood profile

  Baseline and 6 weeks

• Phase 1: Hemoglobin A1C

  Baseline and 6 weeks

• Phase 1: Inflammation

  Baseline and 6 weeks

• Phase 1: Gastrointestinal symptoms

  Baseline and 6 weeks

• Phase 1: Hunger level

  Baseline and 6 weeks

Study Arms (5)

Phase 1: Control

PLACEBO COMPARATOR

A commercially available bread crouton product. To be consumed as 2 x 14g portions per day for 6 weeks.

Other: Bread Crouton

Phase 1: Intervention treatment

EXPERIMENTAL

Prebiotic-like nut and seed mix. To be consumed as 2 x 15g portions per day for 6 weeks

Other: Prebiotic-like nut and seed mix

Phase 1: Secondary Intervention treatment.

OTHER

Probiotic capsule. To be consumed as one capsule per day for 6 weeks.

Dietary Supplement: Probiotic capsule

Phase 2: Control

PLACEBO COMPARATOR

Control breakfast consisting of White bread (3 slices; 128g approx.) and low fat spread (10-15g)

Other: White bread and low fat spread

Phase 2: Intervention

EXPERIMENTAL

Intervention breakfast consisting of White bread (3 slices; 128g approx.) and low fat spread (10-15g) + Prebiotic-like nut and seed mix (2 x 15g portions)

Other: Prebiotic-like nut and seed mix; Other: White bread and low fat spread

Interventions

Prebiotic-like nut and seed mix OTHER

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

Phase 1: Intervention treatment; Phase 2: Intervention

Bread Crouton OTHER

A commercially available bread crouton product.

Phase 1: Control

Probiotic capsule DIETARY_SUPPLEMENT

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

Phase 1: Secondary Intervention treatment.

White bread and low fat spread OTHER

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

Phase 2: Control; Phase 2: Intervention

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Can provide written informed consent through an electronic consent form
• Are able and willing to comply to the study protocol
• Are willing to complete their study tasks on specified dates (including over the Easter Holidays)
• Have completed the PREDICT Food Frequency Questionnaire sent to them via email
• Have not completed the ZOE Nutrition product before
• Are willing to do any of the three treatments to which they may be allocated, and able to complete them safely
• Have BMI between 18.5 kg/m2 and 40 kg/m2
• Are any sex
• Are aged between 35 and 65 years old
• Are based in the UK for the duration of the study and can have a study kit delivered to their location

You may not qualify if:

• Cannot eat the test treatments safely and comfortably (suffer from inflammatory bowel disease, coeliac disease, Crohn's disease, irritable bowel syndrome, allergies or intolerances, chronic constipation or chronic diarrhoea)
• Have BMI of less than 18.5 kg/m2 or more than 40 kg/m2
• Follow a non-omnivore diet (vegan, vegetarian)
• Have high fermented food intake at baseline for the preceding month (≥7 servings per week)
• Have high fibre intake at baseline for the preceding month (≥20g per day)
• Taking medication or products in the last 3 months that may modify the measured study outcomes (Antibiotics, non-topical steroids or other immunosuppressive medicines, biologics, probiotics/prebiotics, metformin, chronic use of non-steroidal anti-inflammatory drugs)
• Have used opiate pain medicine for 8 or more days during the last 3 months
• Have used a proton pump inhibitor for 8 or more days during the last 3 months
• Are currently a smoker
• Have experienced a heart attack, stroke, or major surgery in last 2 months
• Have received treatment for cancer in the last 3 months
• Are currently pregnant, breastfeeding or planning a pregnancy
• Are suffering from eating disorders, type 1 or type 2 diabetes mellitus.

Sponsors & Collaborators

• King's College London: lead
• Zoe Global Limited: collaborator

Study Sites (1)

King's College London

London, UK, SE1 9NH, United Kingdom

Location

Related Publications (9)

• Flint HJ, Duncan SH, Scott KP, Louis P. Links between diet, gut microbiota composition and gut metabolism. Proc Nutr Soc. 2015 Feb;74(1):13-22. doi: 10.1017/S0029665114001463. Epub 2014 Sep 30.

  PMID: 25268552 BACKGROUND

• Morrison DJ, Preston T. Formation of short chain fatty acids by the gut microbiota and their impact on human metabolism. Gut Microbes. 2016 May 3;7(3):189-200. doi: 10.1080/19490976.2015.1134082. Epub 2016 Mar 10.

  PMID: 26963409 BACKGROUND

• Shreiner AB, Kao JY, Young VB. The gut microbiome in health and in disease. Curr Opin Gastroenterol. 2015 Jan;31(1):69-75. doi: 10.1097/MOG.0000000000000139.

  PMID: 25394236 BACKGROUND

• Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.

  PMID: 23614584 BACKGROUND

• Andrioaie IM, Duhaniuc A, Nastase EV, Iancu LS, Lunca C, Trofin F, Anton-Paduraru DT, Dorneanu OS. The Role of the Gut Microbiome in Psychiatric Disorders. Microorganisms. 2022 Dec 9;10(12):2436. doi: 10.3390/microorganisms10122436.

  PMID: 36557689 BACKGROUND

• Peng M, Tabashsum Z, Anderson M, Truong A, Houser AK, Padilla J, Akmel A, Bhatti J, Rahaman SO, Biswas D. Effectiveness of probiotics, prebiotics, and prebiotic-like components in common functional foods. Compr Rev Food Sci Food Saf. 2020 Jul;19(4):1908-1933. doi: 10.1111/1541-4337.12565. Epub 2020 May 26.

  PMID: 33337097 BACKGROUND

• Ballini A, Santacroce L, Cantore S, Bottalico L, Dipalma G, Vito D, Saini R, Inchingolo F. Probiotics Improve Urogenital Health in Women. Open Access Maced J Med Sci. 2018 Oct 20;6(10):1845-1850. doi: 10.3889/oamjms.2018.406. eCollection 2018 Oct 25.

  PMID: 30455760 BACKGROUND

• Jenkins AL, Kacinik V, Lyon M, Wolever TM. Effect of adding the novel fiber, PGX(R), to commonly consumed foods on glycemic response, glycemic index and GRIP: a simple and effective strategy for reducing post prandial blood glucose levels--a randomized, controlled trial. Nutr J. 2010 Nov 22;9:58. doi: 10.1186/1475-2891-9-58.

  PMID: 21092221 BACKGROUND

• Chen CO, Rasmussen H, Kamil A, Du P, Blumberg JB. Orange Pomace Improves Postprandial Glycemic Responses: An Acute, Randomized, Placebo-Controlled, Double-Blind, Crossover Trial in Overweight Men. Nutrients. 2017 Feb 13;9(2):130. doi: 10.3390/nu9020130.

  PMID: 28208806 BACKGROUND

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sarah Berry, Dr

  King's College London, ZOE Ltd

  PRINCIPAL INVESTIGATOR

• Tim Spector, Pr

  King's College London, ZOE Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1: Parallel arm randomised control trial Phase 2: Randomised crossover trial

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 30, 2024
• Study Start: January 26, 2024
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: February 26, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)