MedPath

Coffee for Optimal Metabolite Profile

Not Applicable
Completed
Conditions
Healthy
Interventions
Other: Diet
Registration Number
NCT05757154
Lead Sponsor
Chalmers University of Technology
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Coffee BDietCoffee 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.
Coffee ADietCoffee 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.
Coffee CDietCoffe 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.
Primary Outcome Measures
NameTimeMethod
Plasma concentration-time profile over 24 hours (AUC) of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.24 hours

Difference in plasma AUC between the different types of coffee for each biomarker candidate.

Plasma kinetic profiles of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.24 hours

Tmax will be estimated.

Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.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.24 hours

Difference in the urine concentrations between the different types of coffee comparing before (baseline) and after single dose intervention.

Secondary Outcome Measures
NameTimeMethod
Gut microbiome4 days

Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention products.

Urine concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.4 days

Difference in the urine concentrations between the different types of coffee comparing before (baseline) and after single dose and three days intervention.

Blood concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.13 hours

Evaluate new simple sampling techniques using dried blood spots.

Urine metabolites24 hours

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.

Plasma concentrations of key metabolites derived from chlorogenic acid, caffeine, trigonelline and diterpenes.4 days

Difference in the plasma concentrations between the different types of coffee comparing before (baseline) and after single dose and three days intervention.

Plasma metabolites4 days

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.

Trial Locations

Locations (1)

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

πŸ‡ΈπŸ‡ͺ

Gothenburg, Sweden

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