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

Not Applicable

Completed

• Conditions: Obesity, Abdominal
• Interventions: Dietary Supplement: Cafestol 12 mg; Dietary Supplement: Cafestol 6 mg; Dietary Supplement: Placebo

• Registration Number: NCT04911582
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-25
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-03
• Primary Completion: 2021-09-16
• Study Completion: 2021-09-16
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cafestol 12 mg	Cafestol 12 mg	12 mg cafestol
Cafestol 6 mg	Cafestol 6 mg	6 mg cafestol
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Steno Diabetes Center Aarhus; 🇩🇰 Aarhus, Aarhus N, Denmark