Clinical trial NCT03581812: Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms
Official title: Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Microbiome
Eating Behavior
Keywords: Gut Microbiota
Microbiome
Gut Health
Snack
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Queen Mary University of London
name: University of Liverpool
First posted: 2018-07-10
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Faecal bifidobacteria
timeFrame: Baseline
measure: Faecal bifidobacteria
timeFrame: Day 28
Secondary outcomes:
measure: Whole gut transit time
timeFrame: Baseline
measure: Whole gut transit time
timeFrame: Day 28
measure: Regional gut transit time
timeFrame: Baseline
measure: Regional gut transit time
timeFrame: Day 28
measure: Regional gut pH
timeFrame: Baseline
measure: Regional gut pH
timeFrame: Day 28
measure: Faecal gut microbiota (alpha- and beta-diversity)
timeFrame: Baseline
measure: Faecal gut microbiota (alpha- and beta-diversity)
timeFrame: Day 28
measure: Faecal short-chain fatty acids (SCFA)
timeFrame: Baseline
measure: Faecal short-chain fatty acids (SCFA)
timeFrame: Day 28
measure: Faecal water
timeFrame: Baseline
measure: Faecal water
timeFrame: Day 28
measure: Faecal volatile organic compounds
timeFrame: Baseline
measure: Faecal volatile organic compounds
timeFrame: Day 28
measure: Gut symptoms
timeFrame: Week 0
measure: Gut symptoms
timeFrame: week 4
measure: Stool frequency
timeFrame: Week 0
measure: Stool frequency
timeFrame: Week 4
measure: Dietary intake
timeFrame: Week 0
measure: Dietary intake
timeFrame: Week 4
measure: Quality of life
timeFrame: Baseline
measure: Quality of life
timeFrame: Day 28
measure: Mood
timeFrame: Baseline
measure: Mood
timeFrame: Day 28
measure: Physical activity
timeFrame: Baseline
measure: Physical activity
timeFrame: Day 28
measure: Dietary metabolites (various)
timeFrame: Baseline
measure: Dietary metabolites (various)
timeFrame: Day 28
measure: Particle size of masticated snack foods
timeFrame: Day 28
Other outcomes:
measure: Adverse events
timeFrame: From baseline - day 28
measure: Acceptability of snack products
timeFrame: Day 28
Locations:
city: London
country: United Kingdom
facility: King's College London Waterloo Campus
Study officials:
affiliation: King's College London
name: Kevin Whelan, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Creedon AC, Dimidi E, Hung ES, Rossi M, Probert C, Grassby T, Miguens-Blanco J, Marchesi JR, Scott SM, Berry SE, Whelan K. The impact of almonds and almond processing on gastrointestinal physiology, luminal microbiology, and gastrointestinal symptoms: a randomized controlled trial and mastication study. Am J Clin Nutr. 2022 Dec 19;116(6):1790-1804. doi: 10.1093/ajcn/nqac265.