Healthy Clinical Trial
Official title:
Effects of Metformin on Human Gut Microbiota
OBJECTIVE: Investigate structural changes in the human gut microbiota and associated changes
in metabolic markers in urine, saliva, blood and fecal samples following metformin
treatment.
DESIGN: An, 18 week, one-armed cross over intervention trial consisting of a 6-week
pre-intervention period, 6-week intervention period and a 6-week post-intervention period.
25 healthy young men will be included in the trial.
INTERVENTION: Six-week Metformin treatment to young healthy men.
An, 18 weeks, one-armed cross over intervention trial consisting of a 6-weeks
pre-intervention period, 6-weeks intervention period and a 6-weeks post-intervention period.
25 healthy young men will be included in the trial. The pre-intervention period is the
control period with no treatment. During the intervention period participants will receive
500 mg of metformin once daily the 1st week, then 500 mg twice daily the 2nd week, 1000 mg +
500 mg daily the 3rd week and 1000 mg + 1000 mg daily the remaining three weeks.
Post-interventional investigators will examine gut microbiota of the participants 6 weeks
after completion of the intervention period.
MESUREMENTS: Altered composition of gut microbiota as investigated by 16S rRNA sequencing is
the primary outcome of this study. Secondary outcomes are to investigate changes in
metabolic and inflammatory markers in blood and fecal samples. Blood, urine, saliva and
fecal samples will be stored for future studies.
;
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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