Clinical trial NCT06502834: Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Official title: Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Obesity
Metabolic Syndrome
Steatosis of Liver
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2x10 participants will be randomly allocated to placebo or d piger suspension once daily.
Primary purpose: TREATMENT

Brief summary: The goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight.

The investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.

Detailed description: The investigators perform a randomized, placebo controlled trial in 2x10 participants.

The participants will be given placebo or d piger as an oral suspension once daily for 30 days.

At baseline and after 30 days, a fructose challenge test with fomepizole, gastroduodenoscopy and MRI liver + FibroScan will be performed. Patient will attend the clinical trial unit weekly for safety visits.

The participants will be overweight males or females age 18-70 with impaired glucose tolerance.

Eligibility criteria: Inclusion:

Male or (postmenopausal) females

* Increased waist circumference (\>102 cm men, 88\>cm women)
* Insulin resistance (HOMA\>2.5)
* 18-70 years

Exclusion Criteria:

* Use of systemic medication (except for paracetamol), including antibiotics and pro-/prebiotics in the past three months or during the study period.
* A history of a cardiovascular event
* A history of cholecystectomy
* Overt untreated gastrointestinal disease or abnormal bowel habits
* Liver enzymes\>2.5 fold higher than the upper limit of normal range
* Smoking
* Alcohol abuse

Primary outcomes:
measure: Gut engraftment
timeFrame: 30 days
measure: adverse events
timeFrame: 30 days
measure: Renal function
timeFrame: 30 days
measure: Occurence of anemia
timeFrame: 30 days
measure: Changes in leucocytes
timeFrame: 30 days
measure: Changes in thrombocytes
timeFrame: 30 days
measure: Changes in aspartate aminotransferase (AST)
timeFrame: 30 days
measure: Changes in alanine aminotransferase (ALT)
timeFrame: 30 days
measure: Changes in alkaline phosphatase (ALP)
timeFrame: 30 days
measure: Changes in Gamma-glutamyltransferase (GGT)
timeFrame: 30 days
measure: Changes in total bilirubin
timeFrame: 30 days
Secondary outcomes:
measure: Fructose in peripheral blood
timeFrame: 30 days
measure: Fructose metabolites in breath
timeFrame: 30 days
measure: Time-in-range
timeFrame: 30 days
measure: Continuous glucose monitoring
timeFrame: 30 days
measure: Glycemic control
timeFrame: 30 days
measure: Dietary intake
timeFrame: 30 days
measure: Questionnaires
timeFrame: 30 days
measure: Intestinal microbiota composition
timeFrame: 30 days
measure: Fructose metabolites in feces
timeFrame: 30 days
measure: Fructose metabolites in urine
timeFrame: 30 days
measure: Bioreactor analyses
timeFrame: 30 days
measure: MRI
timeFrame: 30 days
measure: FibroScan
timeFrame: 30 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location AMC
Study officials:
affiliation: Amsterdam UMC, location AMC
name: Max Nieuwdorp, prof dr
role: PRINCIPAL_INVESTIGATOR
References: