Coffee for Optimal Metabolite Profile

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Diet

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • University of Gothenburg, Department of Food and Nutrition and Sport Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coffee A; Coffee type A. All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method.	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.
Experimental: Coffee B; Coffee type B. All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method.	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.
Experimental: Coffee C; Coffe type C. All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Cmax will be estimated.	24 hours
Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Tmax will be estimated.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Gut microbiome	Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention products.	4 days
Blood concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.	Evaluate new simple sampling techniques using dried blood spots.	13 hours

Collaborators and Investigators

• Sponsor: Chalmers University of Technology
• Collaborators: Paulig Group
• Investigators: Principal Investigator: Rikard Landberg, Dr, Chalmers University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): July 3, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: February 18, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ChalmersUA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No