ISRCTN16299902已完成未知
Increase in colonic PRopionate as a method of prEVENTing weight gain in adults aged 20-40years (iPREVENT)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 22/04/2021:
- •1. Males and females aged 20-40 years
- •2. BMI of 24-27 kg/m2 if of South Asian ethnicity or 25-30 kg/m2 if non-South Asian, and at least one of the following:
- •2.1. A self-reported weight gain of 2 kg or more over the last 12 months
- •2.2. Low self-reported physical activity (‘inactive’ or ‘minimally active’ as per IPAQ)
- •2.3. Low self-reported fruit and vegetable intake (<2 servings of fruit and vegetables per day)
- •2.4. Self-reported high intake of sugar-sweetened beverages (>1 serving per day)
- •3. On stable medication (if taking any) at point of screening
- •4. Written informed consent
- •Previous inclusion criteria:
- •1. Males and females aged 20-35 years
- •2. BMI of 24-27kg/m2 if of South Asian ethnicity or 25-30kg/m2 if non-South Asian, and at least one of the following:
- •2.1. A self-reported weight gain of 2kg or more over the last 12 months
- •2.2. Low self-reported physical activity (‘inactive’ or ‘minimally active’ as per IPAQ)
- •2.3. Low self-reported fruit and vegetable intake (< 2 servings of fruit and vegetables per day)
- •2.4. Self-reported high intake of sugar sweetened beverages (> 1 serving per day)
- •3. On stable medication (if taking any) at point of screening
- •4. Written informed consent
排除标准
- •Current exclusion criteria as of 04/01/2022:
- •1. Diagnosed with chronic disease: Type I and II diabetes, cancer, renal failure, heart disease, organic
- •acidaemia (propionic acidaemia, methyl malonic acidaemia)
- •2. Diagnosed gastrointestinal condition including coeliac disease, inflammatory bowel disease and irritable bowel syndrome
- •3. Previous bowel reconstruction surgery
- •4. Pregnancy or lactation
- •5. Use of antibiotics at any time in the past 3 months
- •6. Untreated Vitamin B12 deficiency (<160 ng/l)
- •7. Taking part in a weight loss program or consuming a weight loss product
- •8. Have lost 3 kg or more in the last 3 months
- •9. Any other gastrointestinal upset (such as diarrhoea/constipation in the last 2 weeks,abdominal cramping etc)
- •10. Any other reason in the opinion of the investigator
- •For sub-study:
- •1. Known anaemia or as per screening blood results (haemoglobin levels of <130 g/l for males and <110 g/l for females)
- •2. Allergies or intolerances to any of the ingredients in the set sub-study meals
- •Previous exclusion criteria:
- •1. Diagnosed chronic disease; Type I and II diabetes, cancer, renal failure, heart disease, organic acidaemia (propionic acidaemia, methyl malonic acidaemia)
- •2. Diagnosed gastrointestinal condition including coeliac disease, inflammatory bowel disease and irritable bowel syndrome
- •3. Previous bowel reconstruction surgery
- •4. Pregnancy or lactation
- •5. Use of antibiotics at any time in the past 3 months
- •6. Anaemic AND Vitamin B12 deficient (< 160 ng/L)
- •7. Taking part in a weight loss program or consuming a weight loss product
- •8. Have lost 3kg or more in the last 3 months
- •9. Any other gastrointestinal upset (such as diarrhoea/constipation in the last 2 weeks, abdominal cramping etc)
- •10. Any other reason in the opinion of the investigator
研究者
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