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Clinical Trials/NCT04804319
NCT04804319
Completed
Not Applicable

Towards Personalized Dietary Recommendations Based on the Interaction Between Diet, Microbiome and Abiotic Conditions in the Gut

University of Copenhagen1 site in 1 country63 target enrollmentApril 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet, Healthy
Sponsor
University of Copenhagen
Enrollment
63
Locations
1
Primary Endpoint
Faecal pH vs gut microbial saccharolytic/proteolytic metabolism
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to explore the interplay between environmental (abiotic) factors in the gut and the gut microbiota composition, diversity and metabolism. Such insights could help us understand personal responses to diets and be a first step towards personalized dietary recommendations targeting the gut microbiome.

Detailed Description

The study is a 9-day trial including 85 healthy adults in age between 18 and 75. The participants will throughout the trial register their dietary intake, gastrointestinal symptoms including stool frequency and Bristol stool scale, physical activity, and medicine and supplements intake. Participants will on day 3 and day 5, respectively, consume sweet corns to estimate intestinal transit time by the time it takes sweet corn to travel through the gastrointestinal system. Furthermore, the participants will collect daily urine and stool samples. On day 2 and day 9, participants will arrive fasting at the department in the morning and have their anthropometry, breath hydrogen and methane levels measured, and a blood sample will be collected from each participant. The first visit (day 2) also includes a standardized meal test (rye bread, butter, jam, egg, and yogurt with nuts and berries) and intake of paracetamol (250 mg). Subsequently, the participants will stay at the department for the following 6 hours and have their postprandial breath hydrogen and methane measured and urine collected at specific intervals. Moreover, a sub-set of the participants will on the first visit (day 2) immediately after intake of the standardized meal swallow a single-use gastrointestinal SmartPill capsule, which will monitor their gastrointestinal pH, transit time, temperature and pressure.

Registry
clinicaltrials.gov
Start Date
April 13, 2021
End Date
November 29, 2021
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Henrik Munch Roager

Associate Professor

University of Copenhagen

Eligibility Criteria

Inclusion Criteria

  • 18.5-30.0 kg/m2 BMI
  • Willing to daily collect a urine and stool sample at home and able to store them in their own freezer in a provided containers throughout the 9-days trial
  • Willing to eat sweet corn and report corn-intestinal transit time questionnaire
  • Willing to record 9 days dietary intake and defecation pattern
  • Willing to have blood samples drawn two times
  • Owns a device with access to the internet and is willing to use myfood24 platform
  • Known ability to tolerate paracetamol and willing to consume ½ paracetamol tablet dissolved in water (250mg)
  • Willing to eat rye bread, butter, jam, egg, yoghurt, berries and nuts

Exclusion Criteria

  • Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer´s participation
  • Pregnant or lactating women
  • Suffering from inflammatory bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO) or inflammatory bowel diseases (IBD)
  • Intake of antibiotics, diarrhea inhibitors and laxatives ˂ 1month
  • Current chronic or infectious diseases
  • Diagnosis of diabetes
  • History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
  • Frequent intake of painkillers or other medication (mild antidepressants and contraceptive pills are allowed)
  • Concurrent participation in another trial
  • Additional exclusion criteria for the SmartPill sub-study:

Outcomes

Primary Outcomes

Faecal pH vs gut microbial saccharolytic/proteolytic metabolism

Time Frame: Day 1-9

We test whether faecal pH is positively associated with microbial-derived proteolytic metabolites (i.e. p-cresol sulfate and phenylacetylglutamine) in urine and negatively associated with microbial-derived saccharolytic metabolites in faeces (i.e. acetate, butyrate and propionate)

Secondary Outcomes

  • Abiotic factors vs urine metabolome(Day 1-9)
  • Abiotic factors vs blood metabolome(Day 2 and 9)
  • Abiotic factors vs microbial-derived metabolites(Day 1-9)
  • Faecal metagenomics profile vs metabolome(Day 1-9)
  • Abiotic factors vs faecal metagenomic profile(Day 1-9)
  • Abiotic factors vs faecal metabolome(Day 1-9)

Study Sites (1)

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