Long-term Metabolic Effects of Cafestol

January 4, 2023 updated by: University of Aarhus

Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? (Long-term Substudy)

Twelve-week double-blinded, placebo-controlled, parallel intervention study on 40 participants with a large waist circumference who will ingest cafestol or placebo capsules twice daily. Insulin resistance is measured before and after the twelve-week intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants are randomly allocated to the cafestol intervention group or placebo group. Before and after the twelve-week intervention the participants partake in:

  • A modified two-stage Insulin Suppression Test to determine insulin mediated glucose uptake. Fasting participants receive body-surface-area-adjusted octreotide, insulin and glucose infusions for 240 minutes. Octreotide is infused with the same rate throughout the test. Insulin and glucose infusions are slow for the initial 120-minute stage and increased the final 120-minute stage, simulating fasting and post-postprandial conditions, respectively. Steady state measurements of plasma glucose are acquired the final 30 minutes of each stage, at time points 100, 110, 120, 220, 230 and 240 minutes.
  • A mixed meal test. Fasting participants consume 75 g. white bread, 10 g. butter, 30 g. cheese and 200 ml. orange juice. Blood samples are drawn at time points -15, 0, 15, 30, 60, 90, 120, 180 and 240 min for glucose-, insulin-, glucagon- and triglyceride measurements.
  • A Magnetic Resonance Imaging (MRI) scan. Participants undergo dixon-sequences scanning the abdomen, assessing visceral and sub-cutaneous fat volume and liver fat content. Magnetic Resonance (MR) spectroscopy is also used to determine fat percentage of the liver.
  • 24-hour ambulatory blood pressure measurement, every 20 minutes during daytime and every 30 minutes during nighttime.
  • 1-week continuous glucose measurement using blinded continuous glucose monitor/sensor on upper arm.
  • Fecal and urine sampling
  • 72-hour food-diary

  • Fasting blood samples:

    • Insulin, c-peptide, HbA1c and glucose
    • Total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglycerides
    • Thyroid-stimulating hormone (TSH)
    • Alanine aminotransferase, creatinine, sodium and potassium
    • High sensitivity C reactive protein (CRP) and alpha-hydroxybutyrate
    • C-terminal telopeptide (CTX) and Procollagen type 1 N-terminal propeptide (P1NP)
    • Parathyroid hormone (PTH), Vitamin D and Ionized calcium
    • Monocyte Chemoattractant Protein-1 (MCP-1)
    • Interleukin 1 & 8 (IL-1α, IL-1β, IL-8)
    • Gastric inhibitory polypeptide (GIP), Glucagon-like peptide-1 (GLP-1) and Glucagon- like peptide-2 (GLP-2)
    • Growth/differentiation factor 15 (GDF-15)
    • Tumor necrosis factor (TNFα)
    • Fasting assessment of insulin resistance (Homeostatic Model Assessment for Insulin Resistance by C-peptide).

Pre-intervention and end-intervention test results will be compared using repeated-measures ANOVA / mixed models.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • steno diabetes center Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Waist circumference > 102 cm (men) / 88 cm (women)

Exclusion Criteria:

  • Type 2 diabetes (HbA1c > 48 mmol/mol) or in treatment with antidiabetic drugs
  • Pregnancy
  • Planned pregnancy
  • Breastfeeding
  • Significant comorbidity expected to unable the subject from completing visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Cafestol
Participants in this arm ingest 6 mg cafestol capsules twice daily with breakfast and dinner.
Dietary supplement: Cafestol
Capsule with 6 mg cafestol twice daily
Placebo Comparator: Placebo
Participants in this arm ingest placebo capsules twice daily with breakfast and dinner.
Dietary supplement: Placebo
Capsule without cafestol twice daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Steady state plasma glucose during stage 2 of insulin suppression test (mmol/L)
Time Frame: 220, 230 and 240 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.
Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 milliunits (mU) insulin / m2 • minute, and 50 mg glucose / m2 • minute. At time-point 120 minutes, infusion speeds were increased to to 32 mU insulin / m2 • minute and 267 mg glucose / m2 • minute.
220, 230 and 240 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.
Steady state plasma glucose during stage 1 of insulin suppression test (mmol/L)
Time Frame: 100, 110 and 120 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.
Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 mU insulin / m2 • minute, and 50 mg glucose / m2 • min.
100, 110 and 120 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.
Area under the curve for glucose during mixed meal test (mmol/L*min)
Time Frame: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for glucose during a mixed meal test.
-15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the curve for insulin during mixed meal test (pmol/L*min)
Time Frame: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for insulin during a mixed meal test.
-15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for glucagon during mixed meal test (pmol/L*min)
Time Frame: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for glucagon during a mixed meal test.
-15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for triglycerides during mixed meal test (mmol/L*min)
Time Frame: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for triglycerides during a mixed meal test.
-15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Glycated hemoglobin (HbA1c) (mmol/mol)
Time Frame: 12-week change. Comparison between pre-intervention and end-intervention glycated hemoglobin levels.
Glycated hemoglobin (HbA1c) (mmol/mol)
12-week change. Comparison between pre-intervention and end-intervention glycated hemoglobin levels.
Liver fat content (%)
Time Frame: 12-week change. Comparison between pre-intervention scan and end-intervention scan.
Measured with dixon-sequences scanning the abdomen and MR-Spectroscopy.
12-week change. Comparison between pre-intervention scan and end-intervention scan.
Visceral fat content (ml)
Time Frame: 12-week change. Comparison between pre-intervention scan and end-intervention scan.
Measured with dixon-sequences scanning the abdomen
12-week change. Comparison between pre-intervention scan and end-intervention scan.
Subcutaneous fat content (ml)
Time Frame: 12-week change. Comparison between pre-intervention scan and end-intervention scan.
Measured with dixon-sequences scanning the abdomen
12-week change. Comparison between pre-intervention scan and end-intervention scan.
One-week continuous glucose measurement
Time Frame: Average glucose measured every 15 minutes for one week prior to study day 1 and 3. 12-week change. Comparison between pre-intervention measurement and end-intervention measurement.
One-week continuous glucose measurement data.
Average glucose measured every 15 minutes for one week prior to study day 1 and 3. 12-week change. Comparison between pre-intervention measurement and end-intervention measurement.
Blood pressure (mmHg)
Time Frame: 12-week change. Comparison between pre-intervention average ambulatory blood pressure and end-intervention average ambulatory blood pressure.
Average daytime and night-time ambulatory blood pressure. 24-hour ambulatory blood pressure measurement, measured every 20 minutes during daytime and every 30 minutes during nighttime.
12-week change. Comparison between pre-intervention average ambulatory blood pressure and end-intervention average ambulatory blood pressure.
Food consumption in kilocalories (kcal)
Time Frame: 12-week change. Comparison between pre-intervention food consumption and end-intervention food consumption.
Food consumption is registered for 72-hours prior to study day 1 and 3. Food consumption is measured in kilocalories (kcal).
12-week change. Comparison between pre-intervention food consumption and end-intervention food consumption.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Fasting glucose (mmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting insulin (pmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting total cholesterol (mmol/l),
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting HDL (mmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting LDL (mmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting triglycerides (mmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting thyroid-stimulating hormone (international unit (IU)/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting alanine aminotransferase (unit(U)/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting high sensitivity c reactive protein (mg/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting alpha-hydroxybutyrate (mmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting C-terminal telopeptide (µg/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting procollagen type 1 N-terminal propeptide (µg/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting parathyroid hormone (pmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting vitamin D (nmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting ionized calcium (mmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting monocyte chemoattractant protein-1 (pg/ml)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting interleukin 1 (pg/ml)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting interleukin 8 (pg/ml)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting gastric inhibitory polypeptide (pmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting glucagon-like peptide-2 (pmol/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting growth/differentiation factor 15 (ng/l)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting tumor necrosis factor (TNFα)
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Fasting Homeostatic Model Assessment for Insulin Resistance by C-peptide (arbitrary unit).
Time Frame: Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.
Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Søren Gregersen, M.D. Ph.D, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • cafestol.longterm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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