Gut Microbiome Clinical Trial
Official title:
ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem
NCT number | NCT06231706 |
Other study ID # | BIOME |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 26, 2024 |
Est. completion date | May 30, 2024 |
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.
Status | Recruiting |
Enrollment | 399 |
Est. completion date | May 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | King's College London | London | UK |
Lead Sponsor | Collaborator |
---|---|
King's College London | Zoe Global Limited |
United Kingdom,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | Baseline and 6 weeks | |
Secondary | Phase 1: Hemoglobin A1C | The change in Hemoglobin A1C (HbA1c) from baseline to endpoint, measured through finger-prick dried blood spot samples. | Baseline and 6 weeks | |
Secondary | Phase 1: Inflammation | The change in glycoprotein acetylation (GlycA) from baseline to endpoint, measured through finger-prick dried blood spot samples analysed by metabolomics. | Baseline and 6 weeks | |
Secondary | 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. | Baseline and 6 weeks | |
Secondary | Phase 1: Hunger level | The change in hunger level throughout the study duration, measured through questionnaires administered online. | Baseline and 6 weeks | |
Secondary | Phase 1: Energy level | The change in energy level throughout the study duration, measured through questionnaires administered online. | Baseline and 6 weeks | |
Secondary | Phase 1: Mood | The change in mood throughout the study duration, measured through questionnaires administered online. | Baseline and 6 weeks | |
Secondary | Phase 1: Body weight | The change in weight from baseline to endpoint, measured through questionnaires administered online. | Baseline and 6 weeks | |
Secondary | Phase 1: Waist circumference | The change in waist circumference from baseline to endpoint, measured through questionnaires administered online. | Baseline and 6 weeks | |
Secondary | Phase 1: Sleep | The change in sleep quantity and quality throughout the study duration, measured through questionnaires administered online. | Baseline and 6 weeks | |
Secondary | Phase 1: Skin quality | The change in skin quality throughout the study duration, measured through questionnaires administered online. | Baseline and 6 weeks | |
Secondary | Phase 2: Postprandial interstitial glucose (2h iAUC) | Difference in 2h iAUC between intervention and control test meals measured using continuous interstitial glucose monitors. | 2 hours post test meal consumption | |
Secondary | 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. | Within 3 hours post test meal consumption | |
Secondary | 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. | 2-3 hours post test meal consumption | |
Secondary | 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. | 3 hours post test meal consumption. | |
Secondary | Phase 2: Postprandial subjective ratings of hunger (3h iAUC) | Difference in iAUC between intervention and control test meals assessed using visual analog scales. | 3 hours post test meal consumption. | |
Secondary | 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. | 3 hours post test meal consumption | |
Secondary | Phase 2: Postprandial subjective ratings of mood (3h iAUC) | Difference in iAUC between intervention and control test meals assessed by visual analog scales. | 3 hours post test meal consumption. | |
Secondary | 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. | 3 hours post test meal consumption | |
Secondary | 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. | Anticipated 3-6 hours post test meal consumption | |
Secondary | Phase 2: Amount Consumed at Next Meal | Difference in amount consumed next meal between intervention and control test meals assessed by physical food diary. | Anticipated 3-6 hours post test meal consumption | |
Secondary | 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. | Anticipated 3-6 hours post test meal consumption |
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