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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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Twelve-week double-blinded, placebo-controlled, parallel intervention study on 40 participants with a large waist circumference who will ingest cafestol or placebo capsules twice daily. Insulin resistance is measured before and after the twelve-week intervention.
Participants are randomly allocated to the cafestol intervention group or placebo group. Before and after the twelve-week intervention the participants partake in:
A modified two-stage Insulin Suppression Test to determine insulin mediated glucose uptake. Fasting participants receive body-surface-area-adjusted octreotide, insulin and glucose infusions for 240 minutes. Octreotide is infused with the same rate throughout the test. Insulin and glucose infusions are slow for the initial 120-minute stage and increased the final 120-minute stage, simulating fasting and post-postprandial conditions, respectively. Steady state measurements of plasma glucose are acquired the final 30 minutes of each stage, at time points 100, 110, 120, 220, 230 and 240 minutes.
A mixed meal test. Fasting participants consume 75 g. white bread, 10 g. butter, 30 g. cheese and 200 ml. orange juice. Blood samples are drawn at time points -15, 0, 15, 30, 60, 90, 120, 180 and 240 min for glucose-, insulin-, glucagon- and triglyceride measurements.
A Magnetic Resonance Imaging (MRI) scan. Participants undergo dixon-sequences scanning the abdomen, assessing visceral and sub-cutaneous fat volume and liver fat content. Magnetic Resonance (MR) spectroscopy is also used to determine fat percentage of the liver.
24-hour ambulatory blood pressure measurement, every 20 minutes during daytime and every 30 minutes during nighttime.
1-week continuous glucose measurement using blinded continuous glucose monitor/sensor on upper arm.
Fecal and urine sampling
72-hour food-diary
Fasting blood samples:
Pre-intervention and end-intervention test results will be compared using repeated-measures ANOVA / mixed models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cafestol | Active Comparator | Participants in this arm ingest 6 mg cafestol capsules twice daily with breakfast and dinner. |
|
| Placebo | Placebo Comparator | Participants in this arm ingest placebo capsules twice daily with breakfast and dinner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Capsule without cafestol twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Steady state plasma glucose during stage 2 of insulin suppression test (mmol/L) | Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 milliunits (mU) insulin / m2 • minute, and 50 mg glucose / m2 • minute. At time-point 120 minutes, infusion speeds were increased to to 32 mU insulin / m2 • minute and 267 mg glucose / m2 • minute. | 220, 230 and 240 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose. |
| Steady state plasma glucose during stage 1 of insulin suppression test (mmol/L) | Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 mU insulin / m2 • minute, and 50 mg glucose / m2 • min. | 100, 110 and 120 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose. |
| Area under the curve for glucose during mixed meal test (mmol/L*min) | Area under the curve for glucose during a mixed meal test. | -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve for insulin during mixed meal test (pmol/L*min) | Area under the curve for insulin during a mixed meal test. | -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves. |
| Area under the curve for glucagon during mixed meal test (pmol/L*min) |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose (mmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. | |
| Fasting insulin (pmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
Inclusion Criteria:
Waist circumference > 102 cm (men) / 88 cm (women)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Søren Gregersen, M.D. Ph.D | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Aarhus | Aarhus | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| C053400 | cafestol |
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| Cafestol |
| Dietary Supplement |
Capsule with 6 mg cafestol twice daily |
|
Area under the curve for glucagon during a mixed meal test. |
| -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves. |
| Area under the curve for triglycerides during mixed meal test (mmol/L*min) | Area under the curve for triglycerides during a mixed meal test. | -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves. |
| Glycated hemoglobin (HbA1c) (mmol/mol) | Glycated hemoglobin (HbA1c) (mmol/mol) | 12-week change. Comparison between pre-intervention and end-intervention glycated hemoglobin levels. |
| Liver fat content (%) | Measured with dixon-sequences scanning the abdomen and MR-Spectroscopy. | 12-week change. Comparison between pre-intervention scan and end-intervention scan. |
| Visceral fat content (ml) | Measured with dixon-sequences scanning the abdomen | 12-week change. Comparison between pre-intervention scan and end-intervention scan. |
| Subcutaneous fat content (ml) | Measured with dixon-sequences scanning the abdomen | 12-week change. Comparison between pre-intervention scan and end-intervention scan. |
| One-week continuous glucose measurement | One-week continuous glucose measurement data. | Average glucose measured every 15 minutes for one week prior to study day 1 and 3. 12-week change. Comparison between pre-intervention measurement and end-intervention measurement. |
| Blood pressure (mmHg) | Average daytime and night-time ambulatory blood pressure. 24-hour ambulatory blood pressure measurement, measured every 20 minutes during daytime and every 30 minutes during nighttime. | 12-week change. Comparison between pre-intervention average ambulatory blood pressure and end-intervention average ambulatory blood pressure. |
| Food consumption in kilocalories (kcal) | Food consumption is registered for 72-hours prior to study day 1 and 3. Food consumption is measured in kilocalories (kcal). | 12-week change. Comparison between pre-intervention food consumption and end-intervention food consumption. |
| Fasting total cholesterol (mmol/l), | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting HDL (mmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting LDL (mmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting triglycerides (mmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting thyroid-stimulating hormone (international unit (IU)/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting alanine aminotransferase (unit(U)/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting high sensitivity c reactive protein (mg/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting alpha-hydroxybutyrate (mmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting C-terminal telopeptide (µg/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting procollagen type 1 N-terminal propeptide (µg/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting parathyroid hormone (pmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting vitamin D (nmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting ionized calcium (mmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting monocyte chemoattractant protein-1 (pg/ml) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting interleukin 1 (pg/ml) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting interleukin 8 (pg/ml) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting gastric inhibitory polypeptide (pmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting glucagon-like peptide-2 (pmol/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting growth/differentiation factor 15 (ng/l) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting tumor necrosis factor (TNFα) | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| Fasting Homeostatic Model Assessment for Insulin Resistance by C-peptide (arbitrary unit). | Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |