Obesity, Abdominal
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTCafestol 12 mg
Capsule with 12 mg cafestol
DIETARY_SUPPLEMENTPlacebo
Placebo capsule without cafestol
DIETARY_SUPPLEMENTCafestol 6 mg
Capsule with 6 mg cafestol
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve for glucose | -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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve for insulin-response | -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) |
| Area under the curve for cafestol | -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 |
| Area under the curve for GLP-1 (glucagon-like peptide-1) | -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) |
| Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) | -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) |
Countries
Denmark
Outcome results
None listed