Interactions Between Diet, Microbiome and Abiotic Conditions in the Gut

NCT04804319 | Completed

• 1 other identifier: M237
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet, Healthy; Metabolic Disease

Keywords

Microbiome; Metabolomics; Nutrition

Outcome Measures

Primary Outcomes (1)

• Faecal pH vs gut microbial saccharolytic/proteolytic metabolism

  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)

  Day 1-9

Secondary Outcomes (6)

• Abiotic factors vs faecal metagenomic profile

  Day 1-9

• Abiotic factors vs faecal metabolome

  Day 1-9

• 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

Other Outcomes (34)

• Faecal microbiome

  Day 1-9

• Faecal metabolome

  Day 1-9

• In vitro metabolic profiling

  Day 1-9

Interventions

9-days habitual diet OTHER

9-days study with habitual diet including one standardized breakfast on a single day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Technical University of Denmark: collaborator
• KU Leuven: collaborator
• University of Minnesota: collaborator

Study Sites (1)

University of Copenhagen, Department of Nutrition, Exercise and Sports

Copenhagen, 1958, Denmark

Location

Related Publications (1)

• Prochazkova N, Laursen MF, La Barbera G, Tsekitsidi E, Jorgensen MS, Rasmussen MA, Raes J, Licht TR, Dragsted LO, Roager HM. Gut physiology and environment explain variations in human gut microbiome composition and metabolism. Nat Microbiol. 2024 Dec;9(12):3210-3225. doi: 10.1038/s41564-024-01856-x. Epub 2024 Nov 27.

  PMID: 39604623 RESULT

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 18, 2021
• Study Start: April 13, 2021
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

DK (1)