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Completed

NCT Number: NCT03581812

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College London Waterloo Campus

London, SE1 9NH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention snack 1

Dietary Supplement

To be eaten instead of regular snacks twice a day for 4 weeks.

Intervention snack 2

Dietary Supplement

To be eaten instead of regular snacks twice a day for 4 weeks.

Control Snack

Dietary Supplement

To be eaten instead of regular snacks twice a day for 4 weeks.

Primary outcomes

  1. Faecal bifidobacteria

    Time frame: Baseline

    Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples

  2. Faecal bifidobacteria

    Time frame: Day 28

    Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples

Secondary outcomes

  1. Whole gut transit time

    Time frame: Baseline

    Measured using the SmartPill wireless motility capsule

  2. Whole gut transit time

    Time frame: Day 28

    Measured using the SmartPill wireless motility capsule

  3. Regional gut transit time

    Time frame: Baseline

    Measured using the SmartPill wireless motility capsule

  4. Regional gut transit time

    Time frame: Day 28

    Measured using the SmartPill wireless motility capsule

  5. Regional gut pH

    Time frame: Baseline

    Measured using the SmartPill wireless motility capsule

  6. Regional gut pH

    Time frame: Day 28

    Measured using the SmartPill wireless motility capsule

  7. Faecal gut microbiota (alpha- and beta-diversity)

    Time frame: Baseline

    Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples

  8. Faecal gut microbiota (alpha- and beta-diversity)

    Time frame: Day 28

    Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples

  9. Faecal short-chain fatty acids (SCFA)

    Time frame: Baseline

    Measured by gas liquid chromatography of stool sample

  10. Faecal short-chain fatty acids (SCFA)

    Time frame: Day 28

    Measured by gas liquid chromatography of stool sample

  11. Faecal water

    Time frame: Baseline

    Measured by lyophilization of stool sample

  12. Faecal water

    Time frame: Day 28

    Measured by lyophilization of stool sample

  13. Faecal volatile organic compounds

    Time frame: Baseline

    Measured by gas-chromatography mass-spectrometry of stool samples

  14. Faecal volatile organic compounds

    Time frame: Day 28

    Measured by gas-chromatography mass-spectrometry of stool samples

  15. Gut symptoms

    Time frame: Week 0

    Gastrointestinal symptoms rating scale (7-day; questionnaire)

  16. Gut symptoms

    Time frame: week 4

    Gastrointestinal symptoms rating scale (7-day; questionnaire)

  17. Stool frequency

    Time frame: Week 0

    Bristol stool form scale (7-day; questionnaire)

  18. Stool frequency

    Time frame: Week 4

    Bristol stool form scale(7-day; questionnaire)

  19. Dietary intake

    Time frame: Week 0

    7-day food diary

  20. Dietary intake

    Time frame: Week 4

    7-day food diary

  21. Quality of life

    Time frame: Baseline

    SF-36 questionnaire

  22. Quality of life

    Time frame: Day 28

    SF-36 questionnaire

  23. Mood

    Time frame: Baseline

    Hospital anxiety and depression scale

  24. Mood

    Time frame: Day 28

    Hospital anxiety and depression scale

  25. Physical activity

    Time frame: Baseline

    Recent physical activity questionnaire

  26. Physical activity

    Time frame: Day 28

    Recent physical activity questionnaire

  27. Dietary metabolites (various)

    Time frame: Baseline

    Measured in blood sample

  28. Dietary metabolites (various)

    Time frame: Day 28

    Measured in blood sample

  29. Particle size of masticated snack foods

    Time frame: Day 28

    Mechanical sieving and laser diffraction of masticated snack foods

Other outcomes

  1. Adverse events

    Time frame: From baseline - day 28

    Interview-administered questionnaire

  2. Acceptability of snack products

    Time frame: Day 28

    Questionnaire

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Queen Mary University of London
  • University of Liverpool

Registry information

Official study title

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

Acronym: OptiGut

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2018
Registry last updated
Feb 5, 2020

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.

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