ZOE METHOD Study: Measuring Efficacy THrough Outcomes of Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 347
- 试验地点
- 2
- 主要终点
- Fasted blood lipids
研究概览
简要总结
The ZOE Method Study will test the efficacy of personalized nutritional advice, delivered on an individual level through a digital device app; integrating dietary, lifestyle, physiological and metagenomic data, in improving certain cardiometabolic disease risk factors, compared to generalized nutrition advice (control).
详细描述
Personalized nutrition strategies offer potential for targeted dietary treatment and prevention of diet-related disease, and may ultimately serve as a powerful basis for stratified nutrition approaches at public health level. Existing research into personalized nutrition interventions has shown that it is superior compared to general advice when it comes to improving dietary quality, dietary behaviour, and dietary disease-risk biomarkers in a patient population with prediabetes. However, to date, the superiority of a personalized approach in improving the cardiometabolic risk phenotype in an apparently healthy adult population has not been investigated. With diet being an important modifiable factor for cardiometabolic disease risk, its preventative potential at a healthy individual level must be tested.
Public health policies aiming at reducing disease risk are traditionally derived from large-scale, low-precision epidemiological data that focuses on group means, leading to a 'one-size-fits-all' approach to nutritional guidelines. However, recent research shows that metabolic responses to foods and diet show huge variability at fasting and postprandially both within and between individuals, variation that is driven by 'what' we eat, 'how' we eat and 'who' we are. Metabolic responses to repeated dietary challenges are important underlying factors of diet-related disease risk. This warrants the integration of multiple dietary, lifestyle, physiological and metagenomic exposures into prescribed nutritional guidelines for effective disease risk prevention.
The ZOE METHOD Study will test the efficacy of such a personalized approach to nutritional guidance in improving cardiometabolic risk markers in a disease-free adult US population reflective of the general US phenotype.
Using a parallel randomized at-home design, this study will compare the effect of general dietary advice (USDA Dietary Guidelines for Americans) with the ZOE personalized dietary advice integrating exposures of 'what' we eat (logged free-living diet), 'how' we eat (lifestyle, meal context, time of day, exercise, sleep) and 'who' we are (physiological status and metagenomic signatures).
Population:
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
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-70 years
- •Waist circumference greater than ethnic- and sex-specific 25th percentile values:
- •Hispanic > 96.3cm
- •Asian > 87.3cm
- •Black > 92.7cm
- •White > 96.9cm Female
- •Hispanic > 90.7cm
- •Asian > 80.9cm
- •Black > 92.9cm
- •White > 88.3cm
- •Fruit and vegetable intake below 450g/day (equivalent to 3 cups/day)
- •Willing to comply with study protocol
- •Live in the continental US, Hawaii or Alaska, and not in New York State (due to governmental regulations pertaining to dried blood spot testing).
- •Do not meet any of the
排除标准
- •Exclusion Criteria:
- •Have taken part in the ZOE product or any PREDICT study beforehand.
- •Are unable to read and write in English, as the ZOE app is only available in English.
- •Do not complete the first Quest visit successfully
- •Have an iOS/Android device not compatible with app
- •Use medications affecting lipids (lipid lowering drugs e.g statins, anti-diabetic medications, e.g metformin and insulin), supplements including fish oil (unless willing to safely come off these for 4 weeks before the start of the study, and for the duration of study);
- •Have ongoing inflammatory disease e.g rheumatoid arthritis, systemic lupus erythematosus, polymyalgia and other connective tissue diseases.
- •Have had cancer in the last three years, excluding skin cancer.
- •Have chronic gastrointestinal disorders including inflammatory bowel disease (IBD) or Celiac disease (gluten allergy), but not including irritable bowel syndrome (IBS).
- •Are taking the following daily medications: immunosuppressants, corticosteroids, antibiotics in the last three months, not including inhalers.
- •Are users of prescription proton pump inhibitors (PPIs) (such as omeprazole and pantoprazol), unless they are able to stop two weeks before the start of the study and remain off them for the entire duration of the study (provided their treating physician deems it safe for them to do so).
- •Are currently suffering from acute clinically diagnosed depression or anxiety disorder.
- •Have had a heart attack (myocardial infarction) or stroke in the last 6 months.
- •Are pregnant or planning pregnancy in next 12 months, or are breastfeeding
- •Are vegan, have an eating disorder or unwilling to take foods that are part of the study.
- •Have an allergy to adhesives which would prevent proper attachment of the continuous glucose monitor.
结局指标
主要结局
Fasted blood lipids
时间窗: 12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo)
Fasted measurement of triglycerides and LDL-cholesterol (mmol/L) by venous blood draw.
次要结局
- Energy level(12 months (1 wk, 7 wk, 13 wk, 19 wk, 8 mo, 12 mo))
- Body weight(12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo))
- Insulin(12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo))
- Blood pressure(12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo))
- Hip circumference(12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo))
- HbA1c(12 months (0 wk, 19 wk, 8mo, 12mo))
- Apo-B and Apo-A(12 months (0 wk, 19 wk, 8mo, 12mo))
- Gut microbiome health(12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo))
- Waist circumference(12 months (0 wk, 1 wk, 7 wk, 13 wk, 19 wk, 8mo, 12mo))
- Glucose(12 months (0 wk, 1 wk, 13 wk, 19 wk, 8mo, 12mo))
- C-peptide(12 months (0 wk, 19 wk, 8mo, 12mo))
- Postprandial triglyceride level(19 weeks (1 wk, 19 wk))
- Habitual diet quality(12 months (1 wk, 13 wk, 19 wk, 8 mo, 12 mo))