Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms

Eating Behavior Clinical Trial

— OptiGut  

Official title:

Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581812
• Other study ID #: HR-17/18-5341
• Status: Completed
• Phase: N/A
• Start date: April 27, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2020
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Behavior
• Human Microbiome

Intervention

Dietary Supplement:
• Intervention snack 1
To be eaten instead of regular snacks twice a day for 4 weeks.
• Intervention snack 2
To be eaten instead of regular snacks twice a day for 4 weeks.
• Control snack
To be eaten instead of regular snacks twice a day for 4 weeks.

Locations

Country	Name	City	State
United Kingdom	King's College London Waterloo Campus	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College London	Queen Mary University of London, University of Liverpool

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Interview-administered questionnaire	From baseline - day 28
Other	Acceptability of snack products	Questionnaire	Day 28
Primary	Faecal bifidobacteria	Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples	Baseline
Primary	Faecal bifidobacteria	Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples	Day 28
Secondary	Whole gut transit time	Measured using the SmartPill wireless motility capsule	Baseline
Secondary	Whole gut transit time	Measured using the SmartPill wireless motility capsule	Day 28
Secondary	Regional gut transit time	Measured using the SmartPill wireless motility capsule	Baseline
Secondary	Regional gut transit time	Measured using the SmartPill wireless motility capsule	Day 28
Secondary	Regional gut pH	Measured using the SmartPill wireless motility capsule	Baseline
Secondary	Regional gut pH	Measured using the SmartPill wireless motility capsule	Day 28
Secondary	Faecal gut microbiota (alpha- and beta-diversity)	Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples	Baseline
Secondary	Faecal gut microbiota (alpha- and beta-diversity)	Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples	Day 28
Secondary	Faecal short-chain fatty acids (SCFA)	Measured by gas liquid chromatography of stool sample	Baseline
Secondary	Faecal short-chain fatty acids (SCFA)	Measured by gas liquid chromatography of stool sample	Day 28
Secondary	Faecal water	Measured by lyophilization of stool sample	Baseline
Secondary	Faecal water	Measured by lyophilization of stool sample	Day 28
Secondary	Faecal volatile organic compounds	Measured by gas-chromatography mass-spectrometry of stool samples	Baseline
Secondary	Faecal volatile organic compounds	Measured by gas-chromatography mass-spectrometry of stool samples	Day 28
Secondary	Gut symptoms	Gastrointestinal symptoms rating scale (7-day; questionnaire)	Week 0
Secondary	Gut symptoms	Gastrointestinal symptoms rating scale (7-day; questionnaire)	week 4
Secondary	Stool frequency	Bristol stool form scale (7-day; questionnaire)	Week 0
Secondary	Stool frequency	Bristol stool form scale(7-day; questionnaire)	Week 4
Secondary	Dietary intake	7-day food diary	Week 0
Secondary	Dietary intake	7-day food diary	Week 4
Secondary	Quality of life	SF-36 questionnaire	Baseline
Secondary	Quality of life	SF-36 questionnaire	Day 28
Secondary	Mood	Hospital anxiety and depression scale	Baseline
Secondary	Mood	Hospital anxiety and depression scale	Day 28
Secondary	Physical activity	Recent physical activity questionnaire	Baseline
Secondary	Physical activity	Recent physical activity questionnaire	Day 28
Secondary	Dietary metabolites (various)	Measured in blood sample	Baseline
Secondary	Dietary metabolites (various)	Measured in blood sample	Day 28
Secondary	Particle size of masticated snack foods	Mechanical sieving and laser diffraction of masticated snack foods	Day 28