Clinical trial NCT05757154: Coffee for Optimal Metabolite Profile
Official title: Coffee for Optimal Metabolite Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Chalmers University of Technology
Sponsor class: OTHER
Collaborators: name: Paulig Group
First posted: 2023-03-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
timeFrame: 24 hours
measure: Plasma concentration-time profile over 24 hours (AUC) of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
timeFrame: 24 hours
measure: Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
timeFrame: 24 hours
measure: Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
timeFrame: 24 hours
measure: Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
timeFrame: 24 hours
Secondary outcomes:
measure: Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
timeFrame: 4 days
measure: Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
timeFrame: 4 days
measure: Plasma metabolites
timeFrame: 4 days
measure: Urine metabolites
timeFrame: 24 hours
measure: Gut microbiome
timeFrame: 4 days
measure: Blood concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
timeFrame: 13 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: University of Gothenburg, Department of Food and Nutrition and Sport Science
Study officials:
affiliation: Chalmers University of Technology
name: Rikard Landberg, Dr
role: PRINCIPAL_INVESTIGATOR
References: