Long-term Metabolic Effects of Cafestol

Obesity, Abdominal Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Obesity, Abdominal

• NCT number: NCT05672433
• Study type: Interventional
• Source: University of Aarhus
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2022
• Completion date: March 1, 2023