Status:
COMPLETED
Interactions Between Diet, Microbiome and Abiotic Conditions in the Gut
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Technical University of Denmark
KU Leuven
Conditions:
Diet, Healthy
Metabolic Disease
Eligibility:
All Genders
18-75 years
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 understan...
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 fre...
Eligibility Criteria
Inclusion
- 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
- 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:
- Intake of medications potentially altering gastric pH (proton pump inhibitors, histamine receptor antagonists, antacids)
- Intake of medications potentially altering the gastrointestinal motility (prokinetics, antiemetic agents, anticholinergic agents, narcotic analgetics, nonsteroidal anti-inflammatory drugs)
- Dysphagia
Key Trial Info
Start Date :
April 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04804319
Start Date
April 13 2021
End Date
November 29 2021
Last Update
December 6 2024
Active Locations (1)
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1
University of Copenhagen, Department of Nutrition, Exercise and Sports
Copenhagen, Denmark, 1958