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

University of Aarhus

Status: Completed

Conditions: Obesity, Abdominal

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Cafestol 12 mg; Dietary Supplement: Cafestol 6 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04911582

cafestol.acute.waist

Details and patient eligibility

About

Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 3 patient groups, including a placebo group

Cafestol 6 mg

Active Comparator group

Description:

6 mg cafestol

Treatment:

Dietary Supplement: Cafestol 6 mg

Cafestol 12 mg

Active Comparator group

Description:

12 mg cafestol

Treatment:

Dietary Supplement: Cafestol 12 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo