ISRCTN88780852已完成未知
Effect of a diet on healthy food or a Mediterranean diet on change in the composition and function of faecal microbiota and its relationship with the metabolic improvement
Instituto de Salud Carlos III0 个研究点目标入组 44 人开始时间: 2017年4月7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
- 44
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34130026/ (added 17/06/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34959869/ (added 07/06/2023)
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 20/04/2021:
- •1. Men and women
- •2. 30-60 years old - updated 17/10/2018: 30-65 years old
- •3. BMI=25 and <35 kg/m2
- •4. =3 Metabolic Syndrome criteria according to the ATP III harmonised criteria (doi: 10.1016/j.amjcard.2006.08.045)
- •4.1. Hypertension or hypertension treatment
- •4.2. Altered glycemia (=100mg/dl) or treatment
- •4.3. HDL cholesterol (men<40mg/dl or women <50mg/dl) or treatment
- •4.4. Altered triglycerides (=150mg/dl) or treatment
- •4.5. Abnormal waist circumference (men = 102cm or women = 88)
- •5. Following a non-Mediterranean Diet (scoring =9 in the 17-items MedDiet score used in the PREDIMED-Plus intervention trial) (questionnaire available at doi: 10.1093/ije/dyy225)
- •Previous inclusion criteria:
- •1. Men and women
- •2. 30-60 years old - updated 17/10/2018: 30-65 years old
- •3. BMI=25 and <35
- •4. =3 Metabolic Syndrome criteria:
- •4.1. Hypertension or hypertension treatment
- •4.2. Altered glycemia (=100mg/dl)
- •4.3. HDL cholesterol (men<40mg/dl or women <50mg/dl)
- •4.4. Altered triglycerides (=150mg/dl)
- •4.5. Abnormal waist circumference (men = 102cm or women = 88)
排除标准
- •Current inclusion criteria as of 20/04/2021:
- •1. BMI<25kg/m2 or BMI=35
- •2. Type 2 diabetes
- •3. Secondary obesity or related pathologies
- •4. Non-controlled hypertension (Systolic arterial pressure (SAP)>159mmHg; Diastolic arterial pressure (DAP)>99mmHg)
- •5. LDL cholesterol >160mg/dl
- •6. Tryglicerides >400mg/dl
- •7. Mediterranean adscription punctuation >9 (17-items MedDiet PREDIMED Plus questionnaire)
- •8. Frequent nuts consumption (=90g/week)
- •9. Different chronic diseases (inflammatory, infectious, chronic obstructive pulmonary, neoplasias, endocrine, or hematological diseases)
- •10. Leucocytosis (leucocytes >11x10E9)
- •11.Pharmacological treatment (anti-inflammatory, corticoids, hormones or antibiotics)
- •12. Changes of hypertension of lipidic profile medication (last 3 months).
- •13. Body weight loss (>5kg in the last 3 months).
- •14. Lost weight medication changes (last 3 months).
- •15. Breeding or pregnancy.
- •16. Diseases history (hepatic cirrhosis, intestinal inflammatory, intestinal resection).
- •17. Nuts allergy.
- •18. Probiotics, prebiotics or laxatives consumption
- •Previous exclusion criteria:
- •1. BMI<25kg/m2 or BMI=35
- •2. Type 2 diabetes
- •3. Secondary obesity or related pahologies
- •4. Non-controlled hypertension (Systolic arterial pressure (SAP)>159mmHg; Diastolic arterial pressure (DAP)>99mmHg)
- •5. LDL cholesterol >160mg/dl
- •6. Tryglicerides >400mg/dl
- •7. Mediterranean adscription punctuation =7 (PREDIMED trial)
- •8. Frequent nuts consumption (=90g/week)
- •9. Frequent legumes consumption (=120g/week)
- •10. Different chronic diseases (inflammatory, infectious, chronic obstructive pulmonary, neoplasias, endocrine, or hematological diseases)
- •11. Leucocytosis (leucocytes >11x10E9)
- •12.Pharmacological treatment (anti-inflammatory, corticoids, hormones or antibiotics)
- •13. Changes of diabetes, hypertension of lipidic profile medication (last 3 months).
- •14. Body weight loss (>5kg in the last 3 months).
- •15. Lost weight medication changes (last 3 months).
- •16. Breeding or pregnancy.
- •17. Diseases history (hepatic cirrhosis, intestinal inflammatory, intestinal resection).
- •18. Nuts or legumes allergy.
- •19. Probiotics, prebiotics or laxatives consumption
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