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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Frederiksberg、デンマーク、1958
- Department of Nutrition, Exercise and sports, University of Copenhagen
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in gut microbiota composition
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in markers for insulin sensitivity
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in energy expenditure
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Lesli H Larsen, PhD、Department of Nutrition, Exercise and sports, University of Copenhagen
出版物と役立つリンク
一般刊行物
- 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.
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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