Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms (OptiGut)
Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal Symptoms
調査の概要
状態
条件
詳細な説明
Diet is a crucial target for the improvement of human health. In the modern world, diets are diverse and diet related diseases are becoming more and more common. In particular, it is becoming increasingly apparent that the bacteria that live in the gut are strongly linked to both diet and health. Bacteria in the gut can be beneficial or harmful, and the health of the gut relies on the beneficial bacteria outnumbering the harmful ones. Diet has a great impact on the bacterial composition of the gut. In turn, the gut bacteria play diverse roles in human health, influencing not only the gut but also the health of the immune system, heart and brain. Therefore, optimising the composition of the gut bacterial is vital to human health and wellbeing.
It has been shown that snacks between meals contributes 420 - 480 calories per day, almost a quarter of the recommended intake. Therefore, snack choices are an area of diet and lifestyle that have the potential to influence diet and in turn the health of our gut and gut bacteria. We would like to assess the effect of replacing usual snacks with alternative snack foods that we believe have benefits for gut health.
The primary aim of the study is to investigate whether the replacement of usual snacks has an effect on gut bacterial composition, specifically the abundance of Bifidobacteria. Secondary aims include the effect of the intervention snacks on additional measures of gut health such as gut transit time, the frequency and consistency of bowel movements and gut symptoms e.g. heartburn, nausea, belching etc. The effect of snack foods on metabolites in the blood (e.g. glucose, insulin, lipids) will also be determined. Finally the impact of snack replacement on mood and quality of life will be assessed.
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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London、イギリス、SE1 9NH
- King's College London Waterloo Campus
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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:
- Male or female
- Aged between 18-45 years
- Body mass index (BMI) of 18.5 - 29.9 kg/m2
- Regular consumption of snacks (≥2 per day, excluding fruit and nut snacks)
- Low fibre intake (<22 g/d)
- Willing to follow the protocol and provide consent
Exclusion Criteria:
- Allergy or intolerance to snack ingredients (assessed at screening)
- Dislike of study snacks
- Regular consumption of intervention foods as snacks (twice a day in last month)
- Diabetes
- Major active psychiatric conditions (e.g. schizophrenia) or current eating disorder
- Active treatment for cancer in the last year
- Severe renal, cardiac or pulmonary disease or any other chronic medical condition
- Severe oesophagitis, gastritis or duodenitis
- Active diverticulitis or intestinal/colonic strictures
- Crohns disease or Ulcerative colitis
- Abdominal surgery (except appendicectomy or cholecystectomy)
- Irritable bowel syndrome
- Functional constipation
- Functional diarrhoea
- Antibiotics (past 4 weeks)
- Ongoing therapy with drugs affecting gastrointestinal motility
- Use of medical devices (Pacemakers, infusion pumps, insulin pumps)
- Women who are pregnant/lactating/planning pregnancy
- Recent/ongoing consumption of probiotics/prebiotics (past 4 weeks)
- Ongoing abuse of alcohol/drugs/other medication
- Very high physical activity levels
- Unexplained/unintentional weight loss in the past 6 months
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：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Intervention snack 1
Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.
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To be eaten instead of regular snacks twice a day for 4 weeks.
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アクティブコンパレータ：Intervention snack 2
Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon.
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To be eaten instead of regular snacks twice a day for 4 weeks.
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プラセボコンパレーター：Control snack
Control snack food reflecting the macro-nutrient profile of a typical UK snack.
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To be eaten instead of regular snacks twice a day for 4 weeks.
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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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Faecal bifidobacteria
時間枠：Baseline
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Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
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Baseline
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Faecal bifidobacteria
時間枠：Day 28
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Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
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Day 28
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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 |
|---|---|---|
|
Whole gut transit time
時間枠：Baseline
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Measured using the SmartPill wireless motility capsule
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Baseline
|
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Whole gut transit time
時間枠：Day 28
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Measured using the SmartPill wireless motility capsule
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Day 28
|
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Regional gut transit time
時間枠：Baseline
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Measured using the SmartPill wireless motility capsule
|
Baseline
|
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Regional gut transit time
時間枠：Day 28
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Measured using the SmartPill wireless motility capsule
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Day 28
|
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Regional gut pH
時間枠：Baseline
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Measured using the SmartPill wireless motility capsule
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Baseline
|
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Regional gut pH
時間枠：Day 28
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Measured using the SmartPill wireless motility capsule
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Day 28
|
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Faecal gut microbiota (alpha- and beta-diversity)
時間枠：Baseline
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Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
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Baseline
|
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Faecal gut microbiota (alpha- and beta-diversity)
時間枠：Day 28
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Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
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Day 28
|
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Faecal short-chain fatty acids (SCFA)
時間枠：Baseline
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Measured by gas liquid chromatography of stool sample
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Baseline
|
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Faecal short-chain fatty acids (SCFA)
時間枠：Day 28
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Measured by gas liquid chromatography of stool sample
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Day 28
|
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Faecal water
時間枠：Baseline
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Measured by lyophilization of stool sample
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Baseline
|
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Faecal water
時間枠：Day 28
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Measured by lyophilization of stool sample
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Day 28
|
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Faecal volatile organic compounds
時間枠：Baseline
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Measured by gas-chromatography mass-spectrometry of stool samples
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Baseline
|
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Faecal volatile organic compounds
時間枠：Day 28
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Measured by gas-chromatography mass-spectrometry of stool samples
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Day 28
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Gut symptoms
時間枠：Week 0
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Gastrointestinal symptoms rating scale (7-day; questionnaire)
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Week 0
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Gut symptoms
時間枠：week 4
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Gastrointestinal symptoms rating scale (7-day; questionnaire)
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week 4
|
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Stool frequency
時間枠：Week 0
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Bristol stool form scale (7-day; questionnaire)
|
Week 0
|
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Stool frequency
時間枠：Week 4
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Bristol stool form scale(7-day; questionnaire)
|
Week 4
|
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Dietary intake
時間枠：Week 0
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7-day food diary
|
Week 0
|
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Dietary intake
時間枠：Week 4
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7-day food diary
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Week 4
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Quality of life
時間枠：Baseline
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SF-36 questionnaire
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Baseline
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Quality of life
時間枠：Day 28
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SF-36 questionnaire
|
Day 28
|
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Mood
時間枠：Baseline
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Hospital anxiety and depression scale
|
Baseline
|
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Mood
時間枠：Day 28
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Hospital anxiety and depression scale
|
Day 28
|
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Physical activity
時間枠：Baseline
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Recent physical activity questionnaire
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Baseline
|
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Physical activity
時間枠：Day 28
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Recent physical activity questionnaire
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Day 28
|
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Dietary metabolites (various)
時間枠：Baseline
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Measured in blood sample
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Baseline
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Dietary metabolites (various)
時間枠：Day 28
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Measured in blood sample
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Day 28
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Particle size of masticated snack foods
時間枠：Day 28
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Mechanical sieving and laser diffraction of masticated snack foods
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Day 28
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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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Adverse events
時間枠：From baseline - day 28
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Interview-administered questionnaire
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From baseline - day 28
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Acceptability of snack products
時間枠：Day 28
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Questionnaire
|
Day 28
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Kevin Whelan, Prof.、King's College London
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 (実際)
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 (実際)
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
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。