Coffee for Optimal Metabolite Profile

NCT05757154 | Completed

• 1 other identifier: ChalmersUA
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

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

  4 days

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

  4 days

• Plasma metabolites

  4 days

• Urine metabolites

  24 hours

• Gut microbiome

  4 days

Study Arms (3)

Coffee A

EXPERIMENTAL

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

Coffee B

EXPERIMENTAL

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

Coffee C

EXPERIMENTAL

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

Interventions

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.

Coffee A; Coffee B; Coffee C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and males
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chalmers University of Technology: lead
• Paulig Group: collaborator

Study Sites (1)

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

Gothenburg, Sweden

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Rikard Landberg, Dr

  Chalmers University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 7, 2023
• Study Start: March 31, 2023
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)