Coffee for Optimal Metabolite Profile

Healthy Clinical Trial

Official title:

Coffee for Optimal Metabolite Profile

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05757154
• Other study ID #: ChalmersUA
• Status: Completed
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: July 3, 2023

Study information

• Verified date: August 2023
• Source: Chalmers University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this project is to evaluate metabolite profile after consumption of three types of coffee differing in type of bean, degree of roasting and preparation method. Metabolite profiles will be evaluated after a) a single dose b) 3-day consumption. The study will be carried out as a three-way cross-over design with three different types of coffee. Wash-out periods where participants consume their habitual diet are implemented between all intervention periods. The first day of intervention (single dose) includes postprandial measurements during 13 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 3, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Females and males

• 18 to 80 years of age

• Body mass index (BMI) 18.5-30.0 kg/m2

• Fasting glucose = 6.1 mmol/l

• Low density lipoprotein (LDL) cholesterol = 5.30 mmol/l

• Triglycerides = 2.60 mmol/l

• Signed informed consent

Exclusion Criteria:

• Food allergies or intolerances preventing consumption of any products included in the study.

• Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personnel.

• Pregnant, lactating or planning a pregnancy during the study period.

• Antibiotic use for the last 3 months.

• Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study.

• History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Chron's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.)

• Previous major gastrointestinal surgery

• Have type I diabetes

• Thyroid disorder

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Diet
All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method.

Locations

Country	Name	City	State
Sweden	University of Gothenburg, Department of Food and Nutrition and Sport Science	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Chalmers University of Technology	Paulig Group

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Difference in the plasma concentrations between the different types of coffee comparing before (baseline) and after single dose intervention.	24 hours
Primary	Plasma concentration-time profile over 24 hours (AUC) of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Difference in plasma AUC between the different types of coffee for each biomarker candidate.	24 hours
Primary	Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Difference in the urine concentrations between the different types of coffee comparing before (baseline) and after single dose intervention.	24 hours
Primary	Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Cmax will be estimated.	24 hours
Primary	Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Tmax will be estimated.	24 hours
Secondary	Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Difference in the plasma concentrations between the different types of coffee comparing before (baseline) and after single dose and three days intervention.	4 days
Secondary	Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Difference in the urine concentrations between the different types of coffee comparing before (baseline) and after single dose and three days intervention.	4 days
Secondary	Plasma metabolites	Untargeted metabolomics will be performed using established methods for plasma. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect coffee consumption. Baseline compared with after intervention products.	4 days
Secondary	Urine metabolites	Untargeted metabolomics will be performed using established methods for urine. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect coffee consumption. Baseline compared with after intervention products.	24 hours
Secondary	Gut microbiome	Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention products.	4 days
Secondary	Blood concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Evaluate new simple sampling techniques using dried blood spots.	13 hours