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

February 25, 2022 updated by: University of Aarhus

Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? Acute and Longer-term Metabolic Effects of Cafestol. (Acute Substudy)

Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs.

Study Overview

Detailed Description

The study is a acute, double-blinded, randomized, controlled intervention in 15 subjects with abdominal obesity at high risk of developing T2D. Initially, a blood sample is obtained (t=-15 min) and at time point 0, the participants will ingest a capsule containing either 6 or 12mg cafestol or placebo. Immediately hereafter an OGTT commences with ingestion of a 75 g glucose solution. In the following 2 hours blood samples are collected at time points 15, 30, 60, 90, 120 and 180 min. The samples will be used for determination of plasma glucose, insulin and cafestol, as well as GLP-1 and GIP. After a one-week washout period, the subject will undergo the same set-up again, however now with the different dosage of cafestol or placebo. The process is repeated for three weeks until every subject has undergone both interventions and the placebo.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • 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

    • 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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

25 < BMI < 40 kg/m2 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsule without cafestol
Active Comparator: Cafestol 6 mg
6 mg cafestol
Capsule with 6 mg cafestol
Active Comparator: Cafestol 12 mg
12 mg cafestol
Capsule with 12 mg cafestol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve for glucose
Time Frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule (mmol/L)
-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve for cafestol
Time Frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for cafestol during OGTT after ingestion of cafestol or placebo capsule
-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for insulin-response
Time Frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for insulin response during OGTT after ingestion of cafestol or placebo capsule (pmol/L)
-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for GLP-1 (glucagon-like peptide-1)
Time Frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for GLP-1 (glucagon-like peptide-1) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)
-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide)
Time Frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)
-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

Collaborators and Investigators

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

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)

May 25, 2021

Primary Completion (Actual)

September 16, 2021

Study Completion (Actual)

September 16, 2021

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • cafestol.acute.waist

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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