Gut MicrobiomeNCT06231706
ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem
A study testing Prebiotic-like nut and seed mix, Bread Crouton and Probiotic capsule in people with Gut Microbiome and Prebiotic, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Prebiotic, Probiotic
- What is being tested?
- Prebiotic-like nut and seed mix, Bread Crouton and Probiotic capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 399 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jan 2024to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Phase 1:
A considerable body of evidence highlights the close association between the gut microbiome and health, with the roles performed by the microbiome spanning many functions. Firstly, intestinal microbiota are capable of digesting nutrients otherwise inaccessible to humans through gut physiology, to produce short-chain fatty acids, which are the primary energy source for intestinal epithelial cells. Secondly, the microbiome is part of the bi-directional relationship with host immunity and is involved in human immune homeostasis and immunological recognition that is both innate and adaptive. Moreover, dysbiosis of the gut microbiome has been reported in multiple disease states, including irritable bowel disease, inflammatory bowel disease, gut infections, cardiovascular disease, and psychological conditions such as depression and anxiety.
The differences observed in host gut microbiome communities between healthy and diseased states, and between different dietary patterns, has led to an increase in the use of dietary modulations in an attempt 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 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). Both compounds can be found naturally in foods; for example, many nuts and seeds contain prebiotic compounds such as fibre. Furthermore, foods can also be functionally modified to increase their content of prebiotics and probiotics. Finally, dietary supplementation with such compounds has also been shown to confer positive effects on health. However, the efficacy of dietary interventions involving supplementation in improving health in disease-free, free-living populations is not well understood.
The present study aims to investigate the efficacy of prebiotic and probiotic compounds in improving health, using a randomised parallel controlled trial design of 6-week intervention duration, in a healthy UK adult population, in a remote setting. The study design includes 2 treatments and a control: (i) a prebiotic-like nut and seed mix, consisting of whole-food ingredients high in plant polyphenolic compounds, fibre and micronutrients; (ii) a single-strain probiotic containing Lactobacillus rhamnosus GG, provided in capsule form; (iii) a bread crouton acting as a control (which can be used in a functionally equivalent application to the prebiotic).
Recruitment:
Participants will be recruited from within the ZOE Nutrition Product queue and ZOE mailing list to take part in this study. This queue, or waitlist, consists of individuals who have purchased the ZOE Nutrition Product but have not yet taken part in it. The ZOE mailing list consists of individuals who have registered interest in ZOE Health research studies and consented to be contacted in future. In addition, those that have consented to be contacted will be permitted to share the invitation to join the study with friends and family who may be interested in participating. Each potential participant will receive a study invitation via email, with a link to an online Participant Information Sheet, and will complete a two-step eligibility screening, before being given the option to consent to the study.
Study Design:
The study period requiring interaction of participants with the study staff will span a total of 9 weeks. The first 3 weeks of this period form the onboarding or run-in phase, during which participants will get detailed protocol instructions that they can discuss verbally with study staff. They will also provide their baseline measures during this time, in the week immediately prior to the commencement of their treatment.
The treatment phase will take the form of a 6-week randomised-controlled trial. Participants will be randomly assigned to one of three dietary intervention arms, which all contain commercially available products or products that are in the process of being brought to market:
- Prebiotic-like nut and seed mix, designed by ZOE Ltd. Consumed as 2 x15g portions per day for 6 weeks.
- Probiotic capsule containing the single strain Lactobacillus rhamnosus GG. Consumed as a single capsule portion (providing 15 billion CFUs) per day for 6 weeks.
- Bread croutons. Consumed in portions of 10 croutons twice per day for 6 weeks (this portion is isocaloric to the nut and seed mix).
Participants will be instructed to consume the product of their allocated treatment arm in addition to their habitual diet. They will be asked to ensure their habitual diet remains unchanged throughout the study.
During the study, participants will be asked to complete the following tasks:
Dietary intake questionnaires. Dietary intake will be measured as both short-term intake and habitual intake. Short-term intake will be assessed through the 24 hr recall online tool 'Intake24', to be completed at three timepoints throughout the study (baseline (week 0); midpoint (week 4); and end of treatment (week 6)). Each timepoint will consist of 3 Intake24 records filled out on 3 days (2 weekdays + 1 weekend day). Habitual intake will be assessed through the PREDICT-Food Frequency Questionnaire (PREDICT-FFQ, a validated tool, in press), at one time point during the study (at screening, used as baseline).
Eating behaviour questionnaire. The participant's eating behaviour including eating window and diet patterns will be assessed at baseline (week 0), midpoint (week 4) and endpoint (week 6).
Health history questionnaire. This will be completed at baseline only, and will measure the baseline medical and health status of the participant.
Nutritional, general well-being and bowel symptom questionnaires. Hunger, mood, energy, skin quality, gastrointestinal symptoms and bowel habits will be measured by an online survey, at baseline and weekly throughout the study (7 timepoints in total).
Anthropometrics (weight, height, hip and waist circumference) will be self-reported through an online survey, at baseline (week 0) and endpoint (week 6).
Lifestyle questionnaires. Sleep quality, sleep quantity, and level of physical activity will be assessed at baseline and weekly throughout the study (7 timepoints in total).
Participant adherence questionnaires. These will be used to confirm the quantity of the treatment product that has been consumed by the participant, and to measure self-reported participant compliance to the study tasks. This will be completed weekly throughout the study treatment phase (6 timepoints in total).
Stool sampling. Using an at-home sampling kit, participants will collect a stool sample at two points throughout the study (baseline (week 0) and endpoint (week 6)).
Finger-prick dried blood spot (DBS) tests. Participants will complete these using an at-home sampling kit, at two points throughout the study (baseline (week 0) and endpoint (week 6))
Communication with Study Staff:
All procedures involved in the trial will be performed remotely. Participants will complete a live welcome call with study staff via video call in order to brief participant on their allocated intervention and study procedures. Throughout the trial participants will have access to live communication with members of study staff via email and phone.
Phase 2:
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 health effects of the prebiotic-like nut and seed mix, on postprandial responses, a randomised controlled crossover design postprandial study will be conducted.
We hypothesise that consumption of a high carbohydrate breakfast in combination with the prebiotic-like nut and seed mix (2 x 15g portions = 9g fibre) will decrease the postprandial glycaemic response, and improve postprandial subjective ratings of hunger, mood and alertness in comparison to the consumption of a high carbohydrate breakfast alone (control). The impact of the nut and seed mix on subsequent eating behaviours (time to next meal, amount consumed at next meal) will be investigated. Using a randomised crossover design, 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.
Trial Objectives:
The primary objective of the randomised crossover trial is to evaluate the efficacy of a prebiotic-like nut and seed mix in modulating acute postprandial glucose responses when co-ingested with a carbohydrate rich breakfast.
Recruitment:
Phase 2 will be completed in a sub-group of participants recruited to Phase 1 of this study. Participants who were randomised to the control arm, and have completed phase 1 of the BIOME study will be given the option to take part in Phase 2. Each potential participant will receive a study invitation via email, with a link to an online Participant Information Sheet, and will complete a two-step eligibility screening, before being given the option to consent to the study.
Design:
A randomised crossover trial design, in a healthy UK adult population. Participants will consume 2 test meals in duplicate in a random order. Each meal will be separated by a minimum 2 day washout period. Participants will consume control and test breakfast meals in duplicate and the postprandial glucose responses will be measured using data collected from continuous interstitial glucose monitors. Breakfast test meals will consist of commercially available food products (bread and low-fat spread) and a novel blend of whole-food ingredients high in plant polyphenolic compounds, fibre and micronutrients (prebiotic-like nut and seed mix). Following an overnight fast, participants will consume one of two test meals:
White bread (providing approx. 55-60g CHO; 3g fibre) + Low-fat spread (10-15g) + Prebiotic-like nut and seed mix (2 x 15g portions, ~9g Fibre).
White bread (providing approx. 55-60g CHO; 3g fibre) + Low-fat spread (10-15g)
Following consumption of the test meals participants will be asked to fast for 3 hours during which time they may only consume water (the amount of which will be recorded on the first test day and replicated across all test days).
During testing days participants will be asked to complete visual analog scales (VAS) regarding subjective levels of hunger and mood.
All procedures involved in the trial will be performed remotely. Participants will complete a live welcome call with study staff via video call in order to brief participants on the study procedures. Throughout the trial participants will have access to live communication with members of study staff via email and phone.
- Conditions
- Gut Microbiome, Prebiotic, Probiotic, Postprandial Period
- Being tested
- Prebiotic-like nut and seed mix, Bread Crouton, Probiotic capsule, White bread and low fat spread
- Keywords
- Gut Microbiome, Hunger, Mood, Energy, Postprandial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic-like nut and seed mixOther
A mixture of nuts, seeds and other plant based ingredients.
Bread CroutonOther
A commercially available bread crouton product.
Probiotic capsuleDietary supplement
Contains the single strain Lactobacillus rhamnosus GG at 15 billion CFUs per capsule.
White bread and low fat spreadOther
Consists of 3 slices of bread (providing approx. 55-60g CHO; 3g fibre) + low fat spread (10-15g)
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Control | Placebo comparator | A commercially available bread crouton product. To be consumed as 2 x 14g portions per day for 6 weeks. Receives: 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 Receives: 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. Receives: 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) Receives: 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) Receives: Other: Prebiotic-like nut and seed mix; Other: White bread and low fat spread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Microbiome Composition
The change in relative abundance of microbiome species from baseline to endpoint, derived from metagenomic analysis of stool samples.
Measured: Baseline and 6 weeks
Phase 2: Peak postprandial interstitial glucose concentration (C-Max)
Difference in C-Max between intervention and control meals.
Measured: Within 3 hours post test meal consumption
Secondary outcomes (22)
Phase 1: Lipid blood profile
The change in lipid markers (triglycerides, total cholesterol, HDL-C, LDL-C, and lipoproteins) from baseline to endpoint, measured through finger-prick dried blood spot samples analysed by metabolomics.
Measured: Baseline and 6 weeks
Phase 1: Hemoglobin A1C
The change in Hemoglobin A1C (HbA1c) from baseline to endpoint, measured through finger-prick dried blood spot samples.
Measured: Baseline and 6 weeks
Phase 1: Inflammation
The change in glycoprotein acetylation (GlycA) from baseline to endpoint, measured through finger-prick dried blood spot samples analysed by metabolomics.
Measured: Baseline and 6 weeks
Phase 1: Gastrointestinal symptoms
The change in gastrointestinal symptoms throughout the study duration, measured through questionnaires administered online. Symptoms measured include abdominal bloating, bowel movement frequency and form, indigestion and others.
Measured: Baseline and 6 weeks
Phase 1: Hunger level
The change in hunger level throughout the study duration, measured through questionnaires administered online.
Measured: Baseline and 6 weeks
Phase 1: Energy level
The change in energy level throughout the study duration, measured through questionnaires administered online.
Measured: Baseline and 6 weeks
Phase 1: Mood
The change in mood throughout the study duration, measured through questionnaires administered online.
Measured: Baseline and 6 weeks
Phase 1: Body weight
The change in weight from baseline to endpoint, measured through questionnaires administered online.
Measured: Baseline and 6 weeks
Phase 1: Waist circumference
The change in waist circumference from baseline to endpoint, measured through questionnaires administered online.
Measured: Baseline and 6 weeks
Phase 1: Sleep
The change in sleep quantity and quality throughout the study duration, measured through questionnaires administered online.
Measured: Baseline and 6 weeks
Phase 1: Skin quality
The change in skin quality throughout the study duration, measured through questionnaires administered online.
Measured: Baseline and 6 weeks
Phase 2: Postprandial interstitial glucose (2h iAUC)
Difference in 2h iAUC between intervention and control test meals measured using continuous interstitial glucose monitors.
Measured: 2 hours post test meal consumption
Phase 2: Postprandial Interstitial Glucose Time to Max Concentration (T-Max)
Difference in T-Max between intervention and control test meals measured using continuous interstitial glucose monitors.
Measured: Within 3 hours post test meal consumption
Phase 2: Postprandial Interstitial Glucose dips (2-3h dips)
Difference in 2-3h dips between intervention and control test meals measured using continuous interstitial glucose monitors.
Measured: 2-3 hours post test meal consumption
Phase 2: Postprandial Glucose (time course)
Difference in time course responses of postprandial glucose between intervention and control test meals measured using continuous interstitial glucose monitors.
Measured: 3 hours post test meal consumption.
Phase 2: Postprandial subjective ratings of hunger (3h iAUC)
Difference in iAUC between intervention and control test meals assessed using visual analog scales.
Measured: 3 hours post test meal consumption.
Phase 2: Postprandial subjective ratings of hunger (time-course)
Difference in time course responses of postprandial hunger between intervention and control test meals assessed using visual analog scales.
Measured: 3 hours post test meal consumption
Phase 2: Postprandial subjective ratings of mood (3h iAUC)
Difference in iAUC between intervention and control test meals assessed by visual analog scales.
Measured: 3 hours post test meal consumption.
Postprandial subjective ratings of Mood (time course)
Difference in time course responses of postprandial mood between intervention and control test meals assessed by visual analog scales.
Measured: 3 hours post test meal consumption
Phase 2: Time to next meal
Difference in time taken to consume next meal between intervention and control test meals assessed by physical food diary.
Measured: Anticipated 3-6 hours post test meal consumption
Phase 2: Amount Consumed at Next Meal
Difference in amount consumed next meal between intervention and control test meals assessed by physical food diary.
Measured: Anticipated 3-6 hours post test meal consumption
Phase 2: Nutrient intake at the next meal
Difference in nutrient intake at next meal between intervention and control test meals assessed by physical food diary.
Measured: Anticipated 3-6 hours post test meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start26 Jan 2024
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: Parallel arm randomised control trial Phase 2: Randomised crossover trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Zoe Global Limited
- Responsible party
- Sponsor
- Investigators
- Sarah Berry, Dr, Principal investigator, King's College London, ZOE LtdTim Spector, Pr, Principal investigator, King's College London, ZOE Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231706
- Sponsor's protocol ID
- BIOME
- Status last verified
- May 2024
- First submitted
- 15 Jan 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25268552Morrison 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.
PubMed 26963409Shreiner 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.
PubMed 25394236Tang 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.
PubMed 23614584Andrioaie 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.
PubMed 36557689Peng 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.
PubMed 33337097Ballini 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.
PubMed 30455760Jenkins 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.
PubMed 21092221Chen 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.
PubMed 28208806
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem
- ClinicalTrials.gov ID
- NCT06231706
- Acronym / sponsor ID
- BIOME
- Conditions
- Gut Microbiome, Prebiotic, Probiotic, Postprandial Period
- Keywords
- Gut Microbiome, Hunger, Mood, Energy, Postprandial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Zoe Global Limited
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 1:
A considerable body of evidence highlights the close association between the gut microbiome and health, with the roles performed by the microbiome spanning many functions. Firstly, intestinal microbiota are capable of digesting nutrients otherwise inaccessible to humans through gut physiology, to produce short-chain fatty acids, which are the primary energy source for intestinal epithelial cells. Secondly, the microbiome is part of the bi-directional relationship with host immunity and is involved in human immune homeostasis and immunological recognition that is both innate and adaptive. Moreover, dysbiosis of the gut microbiome has been reported in multiple disease states, including irritable bowel disease, inflammatory bowel disease, gut infections, cardiovascular disease, and psychological conditions such as depression and anxiety.
The differences observed in host gut microbiome communities between healthy and diseased states, and between different dietary patterns, has led to an increase in the use of dietary modulations in an attempt 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 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). Both compounds can be found naturally in foods; for example, many nuts and seeds contain prebiotic compounds such as fibre. Furthermore, foods can also be functionally modified to increase their content of prebiotics and probiotics. Finally, dietary supplementation with such compounds has also been shown to confer positive effects on health. However, the efficacy of dietary interventions involving supplementation in improving health in disease-free, free-living populations is not well understood.
The present study aims to investigate the efficacy of prebiotic and probiotic compounds in improving health, using a randomised parallel controlled trial design of 6-week intervention duration, in a healthy UK adult population, in a remote setting. The study design includes 2 treatments and a control: (i) a prebiotic-like nut and seed mix, consisting of whole-food ingredients high in plant polyphenolic compounds, fibre and micronutrients; (ii) a single-strain probiotic containing Lactobacillus rhamnosus GG, provided in capsule form; (iii) a bread crouton acting as a control (which can be used in a functionally equivalent application to the prebiotic).
Recruitment:
Participants will be recruited from within the ZOE Nutrition Product queue and ZOE mailing list to take part in this study. This queue, or waitlist, consists of individuals who have purchased the ZOE Nutrition Product but have not yet taken part in it. The ZOE mailing list consists of individuals who have registered interest in ZOE Health research studies and consented to be contacted in future. In addition, those that have consented to be contacted will be permitted to share the invitation to join the study with friends and family who may be interested in participating. Each potential participant will receive a study invitation via email, with a link to an online Participant Information Sheet, and will complete a two-step eligibility screening, before being given the option to consent to the study.
Study Design:
The study period requiring interaction of participants with the study staff will span a total of 9 weeks. The first 3 weeks of this period form the onboarding or run-in phase, during which participants will get detailed protocol instructions that they can discuss verbally with study staff. They will also provide their baseline measures during this time, in the week immediately prior to the commencement of their treatment.
The treatment phase will take the form of a 6-week randomised-controlled trial. Participants will be randomly assigned to one of three dietary intervention arms, which all contain commercially available products or products that are in the process of being brought to market:
- Prebiotic-like nut and seed mix, designed by ZOE Ltd. Consumed as 2 x15g portions per day for 6 weeks.
- Probiotic capsule containing the single strain Lactobacillus rhamnosus GG. Consumed as a single capsule portion (providing 15 billion CFUs) per day for 6 weeks.
- Bread croutons. Consumed in portions of 10 croutons twice per day for 6 weeks (this portion is isocaloric to the nut and seed mix).
Participants will be instructed to consume the product of their allocated treatment arm in addition to their habitual diet. They will be asked to ensure their habitual diet remains unchanged throughout the study.
During the study, participants will be asked to complete the following tasks:
Dietary intake questionnaires. Dietary intake will be measured as both short-term intake and habitual intake. Short-term intake will be assessed through the 24 hr recall online tool 'Intake24', to be completed at three timepoints throughout the study (baseline (week 0); midpoint (week 4); and end of treatment (week 6)). Each timepoint will consist of 3 Intake24 records filled out on 3 days (2 weekdays + 1 weekend day). Habitual intake will be assessed through the PREDICT-Food Frequency Questionnaire (PREDICT-FFQ, a validated tool, in press), at one time point during the study (at screening, used as baseline).
Eating behaviour questionnaire. The participant's eating behaviour including eating window and diet patterns will be assessed at baseline (week 0), midpoint (week 4) and endpoint (week 6).
Health history questionnaire. This will be completed at baseline only, and will measure the baseline medical and health status of the participant.
Nutritional, general well-being and bowel symptom questionnaires. Hunger, mood, energy, skin quality, gastrointestinal symptoms and bowel habits will be measured by an online survey, at baseline and weekly throughout the study (7 timepoints in total).
Anthropometrics (weight, height, hip and waist circumference) will be self-reported through an online survey, at baseline (week 0) and endpoint (week 6).
Lifestyle questionnaires. Sleep quality, sleep quantity, and level of physical activity will be assessed at baseline and weekly throughout the study (7 timepoints in total).
Participant adherence questionnaires. These will be used to confirm the quantity of the treatment product that has been consumed by the participant, and to measure self-reported participant compliance to the study tasks. This will be completed weekly throughout the study treatment phase (6 timepoints in total).
Stool sampling. Using an at-home sampling kit, participants will collect a stool sample at two points throughout the study (baseline (week 0) and endpoint (week 6)).
Finger-prick dried blood spot (DBS) tests. Participants will complete these using an at-home sampling kit, at two points throughout the study (baseline (week 0) and endpoint (week 6))
Communication with Study Staff:
All procedures involved in the trial will be performed remotely. Participants will complete a live welcome call with study staff via video call in order to brief participant on their allocated intervention and study procedures. Throughout the trial participants will have access to live communication with members of study staff via email and phone.
Phase 2:
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 health effects of the prebiotic-like nut and seed mix, on postprandial responses, a randomised controlled crossover design postprandial study will be conducted.
We hypothesise that consumption of a high carbohydrate breakfast in combination with the prebiotic-like nut and seed mix (2 x 15g portions = 9g fibre) will decrease the postprandial glycaemic response, and improve postprandial subjective ratings of hunger, mood and alertness in comparison to the consumption of a high carbohydrate breakfast alone (control). The impact of the nut and seed mix on subsequent eating behaviours (time to next meal, amount consumed at next meal) will be investigated. Using a randomised crossover design, 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.
Trial Objectives:
The primary objective of the randomised crossover trial is to evaluate the efficacy of a prebiotic-like nut and seed mix in modulating acute postprandial glucose responses when co-ingested with a carbohydrate rich breakfast.
Recruitment:
Phase 2 will be completed in a sub-group of participants recruited to Phase 1 of this study. Participants who were randomised to the control arm, and have completed phase 1 of the BIOME study will be given the option to take part in Phase 2. Each potential participant will receive a study invitation via email, with a link to an online Participant Information Sheet, and will complete a two-step eligibility screening, before being given the option to consent to the study.
Design:
A randomised crossover trial design, in a healthy UK adult population. Participants will consume 2 test meals in duplicate in a random order. Each meal will be separated by a minimum 2 day washout period. Participants will consume control and test breakfast meals in duplicate and the postprandial glucose responses will be measured using data collected from continuous interstitial glucose monitors. Breakfast test meals will consist of commercially available food products (bread and low-fat spread) and a novel blend of whole-food ingredients high in plant polyphenolic compounds, fibre and micronutrients (prebiotic-like nut and seed mix). Following an overnight fast, participants will consume one of two test meals:
White bread (providing approx. 55-60g CHO; 3g fibre) + Low-fat spread (10-15g) + Prebiotic-like nut and seed mix (2 x 15g portions, ~9g Fibre).
White bread (providing approx. 55-60g CHO; 3g fibre) + Low-fat spread (10-15g)
Following consumption of the test meals participants will be asked to fast for 3 hours during which time they may only consume water (the amount of which will be recorded on the first test day and replicated across all test days).
During testing days participants will be asked to complete visual analog scales (VAS) regarding subjective levels of hunger and mood.
All procedures involved in the trial will be performed remotely. Participants will complete a live welcome call with study staff via video call in order to brief participants on the study procedures. Throughout the trial participants will have access to live communication with members of study staff via email and phone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Phase 1: Parallel arm randomised control trial Phase 2: Randomised crossover trial
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Control | Placebo comparator | Other: Bread CroutonA commercially available bread crouton product. To be consumed as 2 x 14g portions per day for 6 weeks. |
| Phase 1: Intervention treatment | Experimental | Other: Prebiotic-like nut and seed mixPrebiotic-like nut and seed mix. To be consumed as 2 x 15g portions per day for 6 weeks |
| Phase 1: Secondary Intervention treatment. | Other | Dietary Supplement: Probiotic capsuleProbiotic capsule. To be consumed as one capsule per day for 6 weeks. |
| Phase 2: Control | Placebo comparator | Other: White bread and low fat spreadControl breakfast consisting of White bread (3 slices; 128g approx.) and low fat spread (10-15g) |
| Phase 2: Intervention | Experimental | Other: Prebiotic-like nut and seed mix, Other: White bread and low fat spreadIntervention 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) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic-like nut and seed mixA mixture of nuts, seeds and other plant based ingredients. | Other | Phase 1: Intervention treatment, Phase 2: Intervention |
| Bread CroutonA commercially available bread crouton product. | Other | Phase 1: Control |
| Probiotic capsuleContains the single strain Lactobacillus rhamnosus GG at 15 billion CFUs per capsule. | Dietary supplement | Phase 1: Secondary Intervention treatment. |
| White bread and low fat spreadConsists of 3 slices of bread (providing approx. 55-60g CHO; 3g fibre) + low fat spread (10-15g) | Other | Phase 2: Control, Phase 2: Intervention |
Primary outcome
Phase 1: Microbiome Composition
Time frame: Baseline and 6 weeks
The change in relative abundance of microbiome species from baseline to endpoint, derived from metagenomic analysis of stool samples.
Phase 2: Peak postprandial interstitial glucose concentration (C-Max)
Time frame: Within 3 hours post test meal consumption
Difference in C-Max between intervention and control meals.
22 secondary outcomes
Phase 1: Lipid blood profile
Time frame: Baseline and 6 weeks
Phase 1: Hemoglobin A1C
Time frame: Baseline and 6 weeks
Phase 1: Inflammation
Time frame: Baseline and 6 weeks
Phase 1: Gastrointestinal symptoms
Time frame: Baseline and 6 weeks
Phase 1: Hunger level
Time frame: Baseline and 6 weeks
Phase 1: Energy level
Time frame: Baseline and 6 weeks
Phase 1: Mood
Time frame: Baseline and 6 weeks
Phase 1: Body weight
Time frame: Baseline and 6 weeks
Phase 1: Waist circumference
Time frame: Baseline and 6 weeks
Phase 1: Sleep
Time frame: Baseline and 6 weeks
Phase 1: Skin quality
Time frame: Baseline and 6 weeks
Phase 2: Postprandial interstitial glucose (2h iAUC)
Time frame: 2 hours post test meal consumption
Phase 2: Postprandial Interstitial Glucose Time to Max Concentration (T-Max)
Time frame: Within 3 hours post test meal consumption
Phase 2: Postprandial Interstitial Glucose dips (2-3h dips)
Time frame: 2-3 hours post test meal consumption
Phase 2: Postprandial Glucose (time course)
Time frame: 3 hours post test meal consumption.
Phase 2: Postprandial subjective ratings of hunger (3h iAUC)
Time frame: 3 hours post test meal consumption.
Phase 2: Postprandial subjective ratings of hunger (time-course)
Time frame: 3 hours post test meal consumption
Phase 2: Postprandial subjective ratings of mood (3h iAUC)
Time frame: 3 hours post test meal consumption.
Postprandial subjective ratings of Mood (time course)
Time frame: 3 hours post test meal consumption
Phase 2: Time to next meal
Time frame: Anticipated 3-6 hours post test meal consumption
Phase 2: Amount Consumed at Next Meal
Time frame: Anticipated 3-6 hours post test meal consumption
Phase 2: Nutrient intake at the next meal
Time frame: Anticipated 3-6 hours post test meal consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 25268552Flint 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.
- Background: PubMed 26963409Morrison 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.
- Background: PubMed 25394236Shreiner 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.
- Background: PubMed 23614584Tang 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.
- Background: PubMed 36557689Andrioaie 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.
- Background: PubMed 33337097Peng 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.
- Background: PubMed 30455760Ballini 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.
- Background: PubMed 21092221Jenkins 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.
- Background: PubMed 28208806Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Berry, Dr principal investigator
King's College London, ZOE Ltd
Tim Spector, Pr principal investigator
King's College London, ZOE Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic-like nut and seed mix, Bread Crouton and Probiotic capsule in people with Gut Microbiome and Prebiotic, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Microbiome Composition (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06231706, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.