Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Capsule with 12 mg cafestol
Placebo capsule without cafestol
Capsule with 6 mg cafestol
Steno Diabetes Center Aarhus
Aarhus, Aarhus N, Denmark
Area under the curve for glucose
Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule (mmol/L)
Time frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for insulin-response
Area under the curve for insulin response during OGTT after ingestion of cafestol or placebo capsule (pmol/L)
Time frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for cafestol
Area under the curve for cafestol during OGTT after ingestion of cafestol or placebo capsule
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)
Area under the curve for GLP-1 (glucagon-like peptide-1) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)
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)
Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)
Time frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
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