Effects of Lignan-rich Diet on Cardiometabolic Risk Factors
調査の概要
状態
詳細な説明
The study will be conducted in a randomized, cross-over design (8 wk intervention periods). The lignan-rich diet will be based on whole-grain rye products whereas the control diet will be based on whole-grain wheat products with some added wheat bran. Both diets will provide similar amount of whole grain (g/d) and total dietary fiber content (but dietary fibre quality will be different). Although rye has high lignan content, the aim is to further increase the lignan intake half-way through the whole grain rye intervention period. This will allow us to distinguish the effect of lignans from the effect of whole grain rye as well as evaluating potential differences in effects on cardiometabolic risk factors between whole grain wheat and whole grain rye intake after 4-week consumption. The study design will also allow us to investigate the effects of a putative interaction between microbiome x lignan rich diet and its implication of metabolic risk factors.
Blood samples will be collected by trained nurses at screening, baseline, after 4 weeks and 8 weeks of first intervention period, after wash-out (8 weeks), and after 4 weeks and 8 weeks of the second intervention period.
At each examination day participants will arrive to the test laboratory for blood samples and an oral glucose tolerance test (OGTT) where participants will be given a drink with 75 g of glucose to consume within 10 minutes. Blood samples will be taken after 30, 60 and 120 minutes. Furthermore, participants will be instructed to complete one 3-day weighted food record and also to collect 24-h urine and a fecal sample at week 0, 4, 8, 16, 20 and 24.
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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Uppsala、スウェーデン、SE-751 85
- Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
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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 kg/m2
- waist circumference > 102 cm
- at least one of the following: blood pressure >130/85 mmHg, serum triglycerides ≥1.69 mmol/L; HDL cholesterol <1.04 mmol/L; or serum glucose ≥6.1 mmol/L
Exclusion Criteria:
- smokers
- antibiotic use past 6 months
- cancer diagnose (past 5 years) or other chronic disease diagnosis
- excessive alcohol consumption (>21 units/week)
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：Whole-grain rye then wheat
Whole-grain rye, high lignan Whole-grain rye products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain wheat products for 8 weeks
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Intervention week 1-8: 50 g rolled rye + 50 g puffs + 4 pieces of crisp bread + 70 g pasta.
Additionally for intervention week 4-8: 4 lignan capsules per day
Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.
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実験的：Whole-grain wheat then rye
Whole-grain wheat, low lignan Whole-grain wheat products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain rye products for 8 weeks
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Intervention week 1-8: 50 g rolled rye + 50 g puffs + 4 pieces of crisp bread + 70 g pasta.
Additionally for intervention week 4-8: 4 lignan capsules per day
Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.
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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 |
時間枠 |
|---|---|
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Blood glucose levels
時間枠：8 weeks
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8 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Blood lipids
時間枠：8 weeks
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8 weeks
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Inflammatory markers
時間枠：8 weeks
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8 weeks
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Oxidative stress markers
時間枠：8 weeks
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8 weeks
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Enterolignans in blood and urine
時間枠：8 weeks
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8 weeks
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協力者と研究者
捜査官
- 主任研究者：Rikard Landberg、Swedish University of Agricultural Sciences
出版物と役立つリンク
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。