Dietary ExposureBoMoMoNCT06459661
The Bowel Movement Monitoring (BoMoMo) Study
An observational study of Dietary Exposure, run by Leeds Beckett University at 1 site in United Kingdom.
Trial summary
The link between what people eat and how it affects faecal output (poo) has been understudied. Most of the research that has looked at the link between diet, bowel movements and overall health has studied different types of fibre extracted from foods (e.g., fibre extracted from carrots), rather than foods in the form… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Exposure
- What is being tested?
- Diet
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2024to 30 Jun 2024
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults
Who may be able to join
- Age: 18-60 years.
- Healthy as determined from self-reported medical history or when no relevant medical condition exists.
- Stool frequency of 3 to 21 times per week.
- Able to attend a session in person at City Campus or Headingley Campus, Leeds Beckett University, or City Campus, Sheffield Hallam University.
- For women: Use of contraceptive methods or not planning to become pregnant for the duration of the study.
- Able to understand and be willing to sign the informed consent form, and to follow all the study procedures and requirements.
Who cannot join
- Food allergy or intolerance
- Currently dieting to lose weight
- For women: Pregnancy, lactation
- Bowel disease
- Use of medicine causing constipation
- Abnormal gastro-intestinal (gut) function or structure such as malformation, angiodysplasia or active peptic ulcer
Show all 22Show fewer
- History of gastro-intestinal surgery with permanent effect (e.g., surgical treatment of obesity)
- Active inflammatory bowel disease, coeliac disease, chronic pancreatitis, or other disorder potentially causing malabsorption
- Currently experiencing or been diagnosed with gastro-intestinal symptoms (e.g., abdominal pain/cramps, heartburn, stomach acid/reflux, nausea, vomiting, abdominal rumbling, bloating, belching, excess gas/wind)
- Active constipation (i.e., currently constipated).
- Active Irritable Bowel Syndrome
- Currently experiencing disordered eating
- Current use of laxatives
- Current use or within the previous 3 months use of prescription or over-the-counter medication that has the potential of affecting gut bacteria including food supplements (specific medications will be assessed on an individual basis).
- Use of antibiotics or pain medication containing opiates or morphine currently or within the previous 3 months.
- Use of opioid drugs of abuse (e.g., heroin, fentanyl) currently or within the previous 3 months.
- Consumption of more than 21 units of alcohol per week (men)/ more than 14 unit of alcohol per week (women).
- Malignancy/cancer which is currently active or in remission for less than 2 years after treatment.
- Currently experiencing a psychiatric disorder or a condition related with your mental health that impacts on your daily life (e.g., major depression, bipolar disorders).
- Currently engaging in intense physical activity more than 3 times per week (assessed on an individual basis).
- Presenting a psychological or linguistic incapability to sign the informed consent/ Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements.
- Parallel participation in another research project which involves dietary intervention/other clinical trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Beverley O'Hara
Leeds, LS1 3HE
Beverley O'Hara, Ph.D, 44 (0)113 8120000, b.a.ohara@leedsbeckett.ac.uk
Angela Hill, 44 (0)113 8123240 ext. 3240, a.hill@leedsbeckett.ac.uk
About this study
Official title: The Bowel Movement Monitoring (BoMoMo) Study: An Exploration of the Relationship Between Intake of Unrefined, Intact Plant Foods and Faecal Output
The link between what people eat and how it affects faecal output (poo) has been understudied. Most of the research that has looked at the link between diet, bowel movements and overall health has studied different types of fibre extracted from foods (e.g., fibre extracted from carrots), rather than foods in the form that they are consumed.
It is necessary for scientists to investigate the relationship between food as people usual eat it (e.g., a carrot) and bowel movements, as this information is key to understanding the relationship between what people eat and overall health.
The investigators would like to understand the relationship between intake of certain foods and faecal output. This will help to develop a chart, similar to the United Kingdom National Health Service urine colour hydration chart. The chart will allow people to know, by looking at their poo, whether they are eating enough of the foods that will keep them healthy. By monitoring and measuring participants' bowel movements, and providing information about diet, participants will provide the data we need for this research.
Read the detailed description
Participants will complete a 5-day estimated food record and weigh, characterise and photograph each stool for 5 days.
- Conditions
- Dietary Exposure
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Intake of unrefined, intact plant foods
What is being measured
The primary outcome is the main question the study is designed to answer.
Faecal weight
Average weight of faeces
Measured: 5 days
Secondary outcomes (1)
Faecal bulk
Volume of faeces
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 May 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ExposureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds Beckett University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beverley O'Hara, Leeds Beckett University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459661
- Sponsor's protocol ID
- BO01
- Acronym
- BoMoMo
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bowel Movement Monitoring (BoMoMo) Study: An Exploration of the Relationship Between Intake of Unrefined, Intact Plant Foods and Faecal Output
- ClinicalTrials.gov ID
- NCT06459661
- Acronym / sponsor ID
- BoMoMo / BO01
- Conditions
- Dietary Exposure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Leeds Beckett UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 14 Jun 2024 (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 link between what people eat and how it affects faecal output (poo) has been understudied. Most of the research that has looked at the link between diet, bowel movements and overall health has studied different types of fibre extracted from foods (e.g., fibre extracted from carrots), rather than foods in the form that they are consumed.
It is necessary for scientists to investigate the relationship between food as people usual eat it (e.g., a carrot) and bowel movements, as this information is key to understanding the relationship between what people eat and overall health.
The investigators would like to understand the relationship between intake of certain foods and faecal output. This will help to develop a chart, similar to the United Kingdom National Health Service urine colour hydration chart. The chart will allow people to know, by looking at their poo, whether they are eating enough of the foods that will keep them healthy. By monitoring and measuring participants' bowel movements, and providing information about diet, participants will provide the data we need for this research.
Detailed description
Participants will complete a 5-day estimated food record and weigh, characterise and photograph each stool for 5 days.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults
Key inclusion criteria (6 listed)
- Age: 18-60 years.
- Healthy as determined from self-reported medical history or when no relevant medical condition exists.
- Stool frequency of 3 to 21 times per week.
- Able to attend a session in person at City Campus or Headingley Campus, Leeds Beckett University, or City Campus, Sheffield Hallam University.
- For women: Use of contraceptive methods or not planning to become pregnant for the duration of the study.
Key exclusion criteria (22 listed)
- Food allergy or intolerance
- Currently dieting to lose weight
- For women: Pregnancy, lactation
- Bowel disease
- Use of medicine causing constipation
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 |
|---|---|---|
| DietIntake of unrefined, intact plant foods | Other | – |
Primary outcome
Faecal weight
Time frame: 5 days
Average weight of faeces
1 secondary outcome
Faecal bulk
Time frame: 5 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Exposure, run by Leeds Beckett University 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: status not confirmed, as of the sponsor's last update on 17 Jun 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal weight (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2024.