ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 399
- 试验地点
- 2
- 主要终点
- Phase 1: Microbiome Composition
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Phase 1: Microbiome Composition
时间窗: 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)
时间窗: Within 3 hours post test meal consumption
Difference in C-Max between intervention and control meals.
次要结局
- Phase 1: Hunger level(Baseline and 6 weeks)
- Phase 1: Mood(Baseline and 6 weeks)
- Phase 1: Body weight(Baseline and 6 weeks)
- Phase 1: Sleep(Baseline and 6 weeks)
- Phase 1: Skin quality(Baseline and 6 weeks)
- Phase 2: Postprandial interstitial glucose (2h iAUC)(2 hours post test meal consumption)
- Phase 1: Lipid blood profile(Baseline and 6 weeks)
- Phase 1: Inflammation(Baseline and 6 weeks)
- Phase 1: Hemoglobin A1C(Baseline and 6 weeks)
- Phase 1: Gastrointestinal symptoms(Baseline and 6 weeks)
- Phase 1: Energy level(Baseline and 6 weeks)
- Phase 1: Waist circumference(Baseline and 6 weeks)
- Phase 2: Postprandial Interstitial Glucose Time to Max Concentration (T-Max)(Within 3 hours post test meal consumption)
- Phase 2: Postprandial Glucose (time course)(3 hours post test meal consumption.)
- Phase 2: Postprandial Interstitial Glucose dips (2-3h dips)(2-3 hours post test meal consumption)
- Phase 2: Postprandial subjective ratings of mood (3h iAUC)(3 hours post test meal consumption.)
- Phase 2: Postprandial subjective ratings of hunger (3h iAUC)(3 hours post test meal consumption.)
- Phase 2: Postprandial subjective ratings of hunger (time-course)(3 hours post test meal consumption)
- Postprandial subjective ratings of Mood (time course)(3 hours post test meal consumption)
- Phase 2: Amount Consumed at Next Meal(Anticipated 3-6 hours post test meal consumption)
- Phase 2: Time to next meal(Anticipated 3-6 hours post test meal consumption)
- Phase 2: Nutrient intake at the next meal(Anticipated 3-6 hours post test meal consumption)
