Human MicrobiomeOptiGutNCT03581812
Snack Foods and Their Impact on Gastrointestinal Microbiology, Function and Symptoms
A study testing Intervention snack 1 and Intervention snack 2 in people with Human Microbiome and Eating Behavior, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Microbiome, Eating Behavior
- What is being tested?
- Intervention snack 1 and Intervention snack 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Apr 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College London Waterloo Campus
London, SE1 9NH
About this study
Official title: Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal 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.
Read the 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.
- Conditions
- Human Microbiome, Eating Behavior
- Being tested
- Intervention snack 1, Intervention snack 2, Control snack
- Keywords
- Gut Microbiota, Microbiome, Gut Health, Snack
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention snack 1Dietary supplement
To be eaten instead of regular snacks twice a day for 4 weeks.
Intervention snack 2Dietary supplement
To be eaten instead of regular snacks twice a day for 4 weeks.
Control snackDietary supplement
To be eaten instead of regular snacks twice a day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention snack 1 | Active comparator | Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon. Receives: Dietary Supplement: Intervention snack 1 |
| Intervention snack 2 | Active comparator | Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon. Receives: Dietary Supplement: Intervention snack 2 |
| Control snack | Placebo comparator | Control snack food reflecting the macro-nutrient profile of a typical UK snack. Receives: Dietary Supplement: Control snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal bifidobacteria
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
Measured: Baseline
Faecal bifidobacteria
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
Measured: Day 28
Secondary outcomes (29)
Whole gut transit time
Measured using the SmartPill wireless motility capsule
Measured: Baseline
Whole gut transit time
Measured using the SmartPill wireless motility capsule
Measured: Day 28
Regional gut transit time
Measured using the SmartPill wireless motility capsule
Measured: Baseline
Regional gut transit time
Measured using the SmartPill wireless motility capsule
Measured: Day 28
Regional gut pH
Measured using the SmartPill wireless motility capsule
Measured: Baseline
Regional gut pH
Measured using the SmartPill wireless motility capsule
Measured: Day 28
Faecal gut microbiota (alpha- and beta-diversity)
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
Measured: Baseline
Faecal gut microbiota (alpha- and beta-diversity)
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
Measured: Day 28
Faecal short-chain fatty acids (SCFA)
Measured by gas liquid chromatography of stool sample
Measured: Baseline
Faecal short-chain fatty acids (SCFA)
Measured by gas liquid chromatography of stool sample
Measured: Day 28
Faecal water
Measured by lyophilization of stool sample
Measured: Baseline
Faecal water
Measured by lyophilization of stool sample
Measured: Day 28
Faecal volatile organic compounds
Measured by gas-chromatography mass-spectrometry of stool samples
Measured: Baseline
Faecal volatile organic compounds
Measured by gas-chromatography mass-spectrometry of stool samples
Measured: Day 28
Gut symptoms
Gastrointestinal symptoms rating scale (7-day; questionnaire)
Measured: Week 0
Gut symptoms
Gastrointestinal symptoms rating scale (7-day; questionnaire)
Measured: week 4
Stool frequency
Bristol stool form scale (7-day; questionnaire)
Measured: Week 0
Stool frequency
Bristol stool form scale(7-day; questionnaire)
Measured: Week 4
Dietary intake
7-day food diary
Measured: Week 0
Dietary intake
7-day food diary
Measured: Week 4
Quality of life
SF-36 questionnaire
Measured: Baseline
Quality of life
SF-36 questionnaire
Measured: Day 28
Mood
Hospital anxiety and depression scale
Measured: Baseline
Mood
Hospital anxiety and depression scale
Measured: Day 28
Physical activity
Recent physical activity questionnaire
Measured: Baseline
Physical activity
Recent physical activity questionnaire
Measured: Day 28
Dietary metabolites (various)
Measured in blood sample
Measured: Baseline
Dietary metabolites (various)
Measured in blood sample
Measured: Day 28
Particle size of masticated snack foods
Mechanical sieving and laser diffraction of masticated snack foods
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start27 Apr 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human MicrobiomeStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London, University of Liverpool
- Responsible party
- Principal investigator, Professor Kevin Whelan, King's College London
- Investigators
- Kevin Whelan, Prof., Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581812
- Sponsor's protocol ID
- HR-17/18-5341
- Acronym
- OptiGut
- Status last verified
- Feb 2020
- First submitted
- 23 Jun 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36130222
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snack Foods and Their Impact on Gastrointestinal Physiology, Luminal Microbiology and Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT03581812
- Acronym / sponsor ID
- OptiGut / HR-17/18-5341
- Conditions
- Human Microbiome, Eating Behavior
- Keywords
- Gut Microbiota, Microbiome, Gut Health, Snack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Queen Mary University of London, University of Liverpool
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention snack 1 | Active comparator | Dietary Supplement: Intervention snack 1Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon. |
| Intervention snack 2 | Active comparator | Dietary Supplement: Intervention snack 2Snack food believed to selectively promote the growth of beneficial bacterial strains in the human colon. |
| Control snack | Placebo comparator | Dietary Supplement: Control snackControl snack food reflecting the macro-nutrient profile of a typical UK snack. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention snack 1To be eaten instead of regular snacks twice a day for 4 weeks. | Dietary supplement | Intervention snack 1 |
| Intervention snack 2To be eaten instead of regular snacks twice a day for 4 weeks. | Dietary supplement | Intervention snack 2 |
| Control snackTo be eaten instead of regular snacks twice a day for 4 weeks. | Dietary supplement | Control snack |
Primary outcome
Faecal bifidobacteria
Time frame: Baseline
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
Faecal bifidobacteria
Time frame: Day 28
Measured by 16S community profiling (Illumina Miseq) of bacterial genomic DNA isolated from participant stool samples
29 secondary outcomes
Whole gut transit time
Time frame: Baseline
Whole gut transit time
Time frame: Day 28
Regional gut transit time
Time frame: Baseline
Regional gut transit time
Time frame: Day 28
Regional gut pH
Time frame: Baseline
Regional gut pH
Time frame: Day 28
Faecal gut microbiota (alpha- and beta-diversity)
Time frame: Baseline
Faecal gut microbiota (alpha- and beta-diversity)
Time frame: Day 28
Faecal short-chain fatty acids (SCFA)
Time frame: Baseline
Faecal short-chain fatty acids (SCFA)
Time frame: Day 28
Faecal water
Time frame: Baseline
Faecal water
Time frame: Day 28
Faecal volatile organic compounds
Time frame: Baseline
Faecal volatile organic compounds
Time frame: Day 28
Gut symptoms
Time frame: Week 0
Gut symptoms
Time frame: week 4
Stool frequency
Time frame: Week 0
Stool frequency
Time frame: Week 4
Dietary intake
Time frame: Week 0
Dietary intake
Time frame: Week 4
Quality of life
Time frame: Baseline
Quality of life
Time frame: Day 28
Mood
Time frame: Baseline
Mood
Time frame: Day 28
Physical activity
Time frame: Baseline
Physical activity
Time frame: Day 28
Dietary metabolites (various)
Time frame: Baseline
Dietary metabolites (various)
Time frame: Day 28
Particle size of masticated snack foods
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 36130222Creedon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Whelan, Prof. principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention snack 1 and Intervention snack 2 in people with Human Microbiome and Eating Behavior, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal bifidobacteria (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03581812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.