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Completed

NCT Number: NCT05757154

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

All intervention arms are coffee. Three different types of coffee is tested. Differences in type of bean, degree of roasting and preparation method.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

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

    Time frame: 24 hours

    Cmax will be estimated.

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

    Time frame: 24 hours

    Tmax will be estimated.

Secondary outcomes

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

    Time frame: 4 days

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

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

    Time frame: 4 days

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

  3. Plasma metabolites

    Time frame: 4 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.

  4. Urine metabolites

    Time frame: 24 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.

  5. Gut microbiome

    Time frame: 4 days

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

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

    Time frame: 13 hours

    Evaluate new simple sampling techniques using dried blood spots.

Sponsors and collaborators

Lead sponsor

Chalmers University of Technology

Other

Collaborators

  • Paulig Group

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2023
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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