Coffee for Optimal Metabolite Profile

Study Overview
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Brief Summary
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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.

Official Title
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Coffee for Optimal Metabolite Profile

Conditions
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Healthy

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |