- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04911582
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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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