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

Obesity, Abdominal Clinical Trial

Official title:

Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? Acute and Longer-term Metabolic Effects of Cafestol. (Acute Substudy)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911582
• Other study ID #: cafestol.acute.waist
• Status: Completed
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: September 16, 2021

Study information

• Verified date: May 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 16, 2021
• Est. primary completion date: September 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Abdominal

Intervention

Dietary Supplement:
• Cafestol 12 mg
Capsule with 12 mg cafestol
• Placebo
Placebo capsule without cafestol
• Cafestol 6 mg
Capsule with 6 mg cafestol

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Aarhus	Aarhus	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve for glucose	Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule (mmol/L)	-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Secondary	Area under the curve for insulin-response	Area under the curve for insulin response during OGTT after ingestion of cafestol or placebo capsule (pmol/L)	-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Secondary	Area under the curve for cafestol	Area under the curve for cafestol during OGTT after ingestion of cafestol or placebo capsule	-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Secondary	Area under the curve for GLP-1 (glucagon-like peptide-1)	Area under the curve for GLP-1 (glucagon-like peptide-1) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)	-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Secondary	Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide)	Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)	-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution