Trials / Completed
CompletedNCT04911582
Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? (Acute Substudy)
Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? Acute and Longer-term Metabolic Effects of Cafestol. (Acute Substudy)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- University of Aarhus · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Cafestol 12 mg | Capsule with 12 mg cafestol |
| DIETARY_SUPPLEMENT | Placebo | Placebo capsule without cafestol |
| DIETARY_SUPPLEMENT | Cafestol 6 mg | Capsule with 6 mg cafestol |
Timeline
- Start date
- 2021-05-25
- Primary completion
- 2021-09-16
- Completion
- 2021-09-16
- First posted
- 2021-06-03
- Last updated
- 2022-02-28
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04911582. Inclusion in this directory is not an endorsement.