Coffee for Optimal Metabolite Profile
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Plasma concentration-time profile over 24 hours (AUC) of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Plasma concentration-time profile over 24 hours (AUC) of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time Frame: 24 hours
Difference in plasma AUC between the different types of coffee for each biomarker candidate.
Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time Frame: 24 hours
Difference in the plasma concentrations between the different types of coffee comparing before (baseline) and after single dose intervention.
Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time Frame: 24 hours
Difference in the urine concentrations between the different types of coffee comparing before (baseline) and after single dose intervention.
Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.
Time Frame: 24 hours
Cmax will be estimated.
Secondary Outcomes
- Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.(4 days)
- Blood concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.(13 hours)
- Urine metabolites(24 hours)
- Gut microbiome(4 days)
- Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.(4 days)
- Plasma metabolites(4 days)
Investigators
Rikard Landberg
Professor
Chalmers University of Technology