King's College London Waterloo Campus
London, SE1 9NH, United Kingdom
NCT Number: NCT03581812
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.
Looking for future studies?
Notify Me18 year–45 year
All sexes
Interventional
Not applicable
London, SE1 9NH, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To be eaten instead of regular snacks twice a day for 4 weeks.
To be eaten instead of regular snacks twice a day for 4 weeks.
To be eaten instead of regular snacks twice a day for 4 weeks.
Time frame: Baseline
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
Time frame: Day 28
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
Time frame: Baseline
Measured using the SmartPill wireless motility capsule
Time frame: Day 28
Measured using the SmartPill wireless motility capsule
Time frame: Baseline
Measured using the SmartPill wireless motility capsule
Time frame: Day 28
Measured using the SmartPill wireless motility capsule
Time frame: Baseline
Measured using the SmartPill wireless motility capsule
Time frame: Day 28
Measured using the SmartPill wireless motility capsule
Time frame: Baseline
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
Time frame: Day 28
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
Time frame: Baseline
Measured by gas liquid chromatography of stool sample
Time frame: Day 28
Measured by gas liquid chromatography of stool sample
Time frame: Baseline
Measured by lyophilization of stool sample
Time frame: Day 28
Measured by lyophilization of stool sample
Time frame: Baseline
Measured by gas-chromatography mass-spectrometry of stool samples
Time frame: Day 28
Measured by gas-chromatography mass-spectrometry of stool samples
Time frame: Week 0
Gastrointestinal symptoms rating scale (7-day; questionnaire)
Time frame: week 4
Gastrointestinal symptoms rating scale (7-day; questionnaire)
Time frame: Week 0
Bristol stool form scale (7-day; questionnaire)
Time frame: Week 4
Bristol stool form scale(7-day; questionnaire)
Time frame: Week 0
7-day food diary
Time frame: Week 4
7-day food diary
Time frame: Baseline
SF-36 questionnaire
Time frame: Day 28
SF-36 questionnaire
Time frame: Baseline
Hospital anxiety and depression scale
Time frame: Day 28
Hospital anxiety and depression scale
Time frame: Baseline
Recent physical activity questionnaire
Time frame: Day 28
Recent physical activity questionnaire
Time frame: Baseline
Measured in blood sample
Time frame: Day 28
Measured in blood sample
Time frame: Day 28
Mechanical sieving and laser diffraction of masticated snack foods
Time frame: From baseline - day 28
Interview-administered questionnaire
Time frame: Day 28
Questionnaire
King's College London
Other
Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal Symptoms
Acronym: OptiGut
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05295719
Body Weight, Dyslipidemias
Lubbock, Texas, United States
View Trial DetailsNCT05560087
Cardiovascular Diseases, Coronary Disease
Seoul, South Korea
View Trial DetailsNCT02731976
Human Microbiome
Groningen, Netherlands
View Trial DetailsNCT05150184
Human Microbiome
Beltsville, Maryland, United States
View Trial Details