Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Faecal bifidobacteria
研究概览
简要总结
The purpose of this study is to evaluate the impact of replacing usual snacks with alternative snack foods on gut health in a population of habitual snackers with low fibre intake.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
- •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
结局指标
主要结局
Faecal bifidobacteria
时间窗: Day 28
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
次要结局
- Regional gut pH(Day 28)
- Faecal short-chain fatty acids (SCFA)(Day 28)
- Dietary intake(Week 4)
- Dietary metabolites (various)(Day 28)
- Regional gut transit time(Day 28)
- Faecal volatile organic compounds(Day 28)
- Gut symptoms(week 4)
- Quality of life(Day 28)
- Particle size of masticated snack foods(Day 28)
- Whole gut transit time(Day 28)
- Faecal water(Day 28)
- Physical activity(Day 28)
- Faecal gut microbiota (alpha- and beta-diversity)(Day 28)
- Stool frequency(Week 4)
- Mood(Day 28)
研究者
Professor Kevin Whelan
Professor of Dietetics
King's College London