Effect of Prebiotic and PUFA on the Gut Microbiota and Metabolic Risk Markers (MyNewGut)
Effect of Prebiotic Fibre and Polyunsaturated Fatty Acid (PUFA) on the Gut Microbiota and Metabolic Risk Markers in a Metabolically Challenged Population
The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged population, and if the diet-induced modulation of the gut microbiota mediates changes in metabolic risk markers.
Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in the gut microbiota composition and to affect markers for insulin sensitivity, lipid metabolism and inflammation. The investigators hypothesize that the effect of both interventions on the metabolic risk markers will be partly mediated by the diet-induced changes in the gut microbiota composition.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Frederiksberg、丹麦、1958
- Department of Nutrition, Exercise and sports, University of Copenhagen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- BMI: 25-40 kg/m2
- Non-smoking
- Indices of the Metabolic Syndrome defined by the International Diabetes Federation (IDF 2006):
Central obesity (waist circumference; men: ≥94 cm and women: ≥80 cm) + any one of the following; raised triglyceride level (≥1.7 mmol/L), reduced HDL cholesterol (men: <1.03 mmol/L, women: <1.29 mmol/L), raised BP (systolic ≥130 mm Hg or diastolic ≥85 mm Hg) or raised fasting plasma glucose (≥5.6 mmol/L).
Exclusion Criteria:
- Use of antibiotics
- Weight change >3 kg 2 months prior to study start
- Intensive physical training/ elite athlete
- Medication for dyslipidemia, type 2 diabetes or elevated blood pressure
- Dietary supplements with pro/prebiotics, dietary fibre or fish oil supplement
- Lactation, pregnancy or planning of pregnancy during the study
- Gastro intestinal and liver disorders
- Chronic inflammatory disorders
- Diagnosed psychiatric disorder including treatment required depression
- Surgical treatment of obesity and abdominal surgery
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：High fibre diet (wheat bran extract)
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Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&D Centre Europe).
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实验性的：High PUFA diet (fish oil supplement)
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Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in gut microbiota composition
大体时间：Week 0, 4, 8, 12
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Gut microbiota composition will be analyzed by use of fecal samples.
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Week 0, 4, 8, 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in markers for insulin sensitivity
大体时间：Week 0, 4, 8, 12
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Will be measured by use of fasting blood samples
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Week 0, 4, 8, 12
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Change in markers for lipid metabolism
大体时间：Week 0, 4, 8, 12
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Will be measured by use of fasting blood samples
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Week 0, 4, 8, 12
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Change in markers for inflammation
大体时间：Week 0, 4, 8, 12
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Will be measured by use of fasting blood samples
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Week 0, 4, 8, 12
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Faecal SCFA and bile acid composition
大体时间：Week 0, 4, 8, 12
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Will be analyzed by use of fecal samples.
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Week 0, 4, 8, 12
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Lipidomics
大体时间：Week 0, 4, 8, 12
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Will be analyzed by use of fasting blood samples and fecal samples.
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Week 0, 4, 8, 12
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Metabolomics
大体时间：Week 0, 4, 8, 12
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Will be analyzed by use of fasting blood samples, urine and fecal samples.
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Week 0, 4, 8, 12
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in energy expenditure
大体时间：Week 0, 4, 8, 12
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Resting energy expenditure will be measured by indirect calorimetry in a ventilated hood system
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Week 0, 4, 8, 12
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Gene expression
大体时间：Week 0, 4, 8, 12
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Adipose tissue biopsies will be used for epigenetic analyses, gene and protein expression (no whole genome or exome sequencing).
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Week 0, 4, 8, 12
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Compliances markers
大体时间：Week 0, 4, 8, 12
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Compliance will be evaluated from 3-days diet registration and self-reported intake of dietary supplements, PUFA complance markes (fatty acid composition) and body composition
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Week 0, 4, 8, 12
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合作者和调查者
调查人员
- 首席研究员：Lesli H Larsen, PhD、Department of Nutrition, Exercise and sports, University of Copenhagen
出版物和有用的链接
一般刊物
- Benitez-Paez A, Kjolbaek L, Gomez Del Pulgar EM, Brahe LK, Astrup A, Matysik S, Schott HF, Krautbauer S, Liebisch G, Boberska J, Claus S, Rampelli S, Brigidi P, Larsen LH, Sanz Y. A Multi-omics Approach to Unraveling the Microbiome-Mediated Effects of Arabinoxylan Oligosaccharides in Overweight Humans. mSystems. 2019 May 28;4(4):e00209-19. doi: 10.1128/mSystems.00209-19.
- Kjolbaek L, Benitez-Paez A, Gomez Del Pulgar EM, Brahe LK, Liebisch G, Matysik S, Rampelli S, Vermeiren J, Brigidi P, Larsen LH, Astrup A, Sanz Y. Arabinoxylan oligosaccharides and polyunsaturated fatty acid effects on gut microbiota and metabolic markers in overweight individuals with signs of metabolic syndrome: A randomized cross-over trial. Clin Nutr. 2020 Jan;39(1):67-79. doi: 10.1016/j.clnu.2019.01.012. Epub 2019 Feb 19.
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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