NCT05672433

Long-term Metabolic Effects of Cafestol

Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? (Long-term Substudy)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: * Insulin, c-peptide, HbA1c and glucose * Total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglycerides * Thyroid-stimulating hormone (TSH) * Alanine aminotransferase, creatinine, sodium and potassium * High sensitivity C reactive protein (CRP) and alpha-hydroxybutyrate * C-terminal telopeptide (CTX) and Procollagen type 1 N-terminal propeptide (P1NP) * Parathyroid hormone (PTH), Vitamin D and Ionized calcium * Monocyte Chemoattractant Protein-1 (MCP-1) * Interleukin 1 \& 8 (IL-1α, IL-1β, IL-8) * Gastric inhibitory polypeptide (GIP), Glucagon-like peptide-1 (GLP-1) and Glucagon- like peptide-2 (GLP-2) * Growth/differentiation factor 15 (GDF-15) * Tumor necrosis factor (TNFα) * Fasting assessment of insulin resistance (Homeostatic Model Assessment for Insulin Resistance by C-peptide). Pre-intervention and end-intervention test results will be compared using repeated-measures ANOVA / mixed models.

Conditions

• Obesity, Abdominal

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Capsule without cafestol twice daily
DIETARY_SUPPLEMENT	Cafestol	Capsule with 6 mg cafestol twice daily

Timeline

• Start date: 2022-06-28
• Primary completion: 2023-02-01
• Completion: 2023-03-01
• First posted: 2023-01-05
• Last updated: 2023-01-05

Locations

1 site across 1 country: Denmark