ISRCTN63745549已完成未知
Smart Technologies for personAlised Nutrition and Consumer Engagement (Stance4Health)
niversity of Granada0 个研究点目标入组 408 人开始时间: 2021年10月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 408
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35627049/ (added 31/05/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Study population 1 (normal-weight and overweight adults):
- •1. Age 20 - 65 years
- •2. Apparently healthy
- •3. BMI 20-28 kg/m²
- •4. Weight stable
- •5. Use of smartphone
- •6. Internet connection
- •Study population 2:
- •1. BMI =95 percentile for age, gender and height, males 6-11 years, females 6-11 years
- •2. Diagnosed with celiac disease, aged 6-11 years, on elimination (gluten-free) diet and allergic to gluten (very few), on elimination (gluten-free) diet
- •3. Age males 6-11-years, females 6-11 years and one of the following:
- •3.1. IgE-mediated milk allergy, on elimination diet from infancy
- •3.2. Lactose intolerance (symptoms plus breath hydrogen positive test)
- •3.3. Overgrown IgE-mediated milk allergy but current aversion for milk
- •3.4. Nondefinable phenotype (children who avoid milk but do not belong to any of the previous phenotypes)
- •4. BMI >5th and <85th percentile for age, gender, and height, age: males 6-11 years, females 6-11 years
- •Updated 22/07/2022:
- •Study population 2:
- •1. BMI =95 percentile for age, gender and height, males 5-11 years, females 5-11 years
- •2. Diagnosed with celiac disease, aged 5-11 years, on elimination (gluten-free) diet and allergic to gluten (very few), on elimination (gluten-free) diet
- •3. Age males 5-11 years, females 5-11 years and one of the following:
- •3.1. IgE-mediated milk allergy, on elimination diet from infancy
- •3.2. Lactose intolerance (symptoms plus breath hydrogen positive test)
- •3.3. Overgrown IgE-mediated milk allergy but current aversion for milk
- •3.4. Nondefinable phenotype (children who avoid milk but do not belong to any of the previous phenotypes)
- •4. BMI >5th and <85th percentile for age, gender, and height, age: males 5-11 years, females 5-11 years
排除标准
- •Study population 1 (normal-weight and overweight adults):
- •1. Diagnosis of chronic GI disorders, diabetes, celiac disease, or chronic diseases
- •2. Present pregnancy or lactation (<6 weeks prior to study start), or planning to get pregnant
- •3. Recent inflammation and/or long-term use of anti-inflammatory drugs
- •4. Medically prescribed diet or specific dietary regimens for any reasons (i.e. high-protein diet, vegetarianism, veganism, etc)
- •5. Antibiotic treatment (<3 months prior to study start)
- •6. Intake of antioxidant, pre- or probiotic supplements (< 1 month prior to study start)
- •7. Intense physical activity (>10 h/week)
- •8. Alcohol consumption >21 drinks/week for men and >14 drinks/week for women
- •Study population 2:
- •1. GI disease, endocrinopathies, probiotics in the last 2 weeks
- •2. Never symptoms
- •3. Other gastrointestinal comorbidities
- •4. Chronic GI disorders, any other chronic disease, elimination diet, probiotics in the last 2 weeks
研究者
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