Long-term Metabolic Effects of Cafestol

University of Aarhus

Status: Active, not recruiting

Conditions: Obesity, Abdominal

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cafestol

Study type: Interventional

Funder types: Other

Identifiers

NCT05672433

cafestol.longterm

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Cafestol

Active Comparator group

Description:

Participants in this arm ingest 6 mg cafestol capsules twice daily with breakfast and dinner.

Treatment:

Dietary Supplement: Cafestol

Placebo

Placebo Comparator group

Description:

Participants in this arm ingest placebo capsules twice daily with breakfast and dinner.

Treatment:

Dietary Supplement: Placebo