NCT06459661

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 3, 2024

Last Update Submit

June 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Faecal weight

    Average weight of faeces

    5 days

Secondary Outcomes (1)

  • Faecal bulk

    5 Days

Other Outcomes (2)

  • Time to pass stool

    5 Days

  • Stool type

    5 Days

Interventions

DietOTHER

Intake of unrefined, intact plant foods

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beverley O'Hara

Leeds, LS1 3HE, United Kingdom

RECRUITING

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer (Nutrition)

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 14, 2024

Study Start

May 1, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

June 17, 2024

Record last verified: 2024-06

Locations