Effect of 4 Weeks of Oral D. Piger on Safety, Pharmacokinetics and Ethanol Metabolism in Overweight Individuals (2023)

Launched by MAX NIEUWDORP · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a specific supplement called D. Piger affects the body’s production and processing of alcohol in overweight individuals. The researchers want to see if taking this supplement for four weeks can change the levels of alcohol in the blood and analyze how it interacts with the gut. This study is currently looking for participants aged 18 to 70 who are either male or postmenopausal females and have certain health conditions, such as a larger waist size indicating obesity and signs of insulin resistance.

If you qualify and choose to participate, you will be part of a group of 20 people who will receive the supplement and have your blood and stool tested during the study. It's important to note that participants should not have taken certain medications or have specific health issues, such as a history of heart problems or liver disease, in the recent past. This trial aims to gather important information that might help in understanding how this supplement can benefit those with metabolic challenges.

Gender

ALL

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