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

Primary Purpose

Obesity, Abdominal

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Cafestol 12 mg

Placebo

Cafestol 6 mg

About this trial

This is an interventional treatment trial for Obesity, Abdominal

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Steno Diabetes Center Aarhus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cafestol 6 mg

Cafestol 12 mg

Placebo

Arm Description

6 mg cafestol

12 mg cafestol

Placebo

Outcomes

Primary Outcome Measures

Area under the curve for glucose

Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule (mmol/L)

Secondary Outcome Measures

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)

Area under the curve for cafestol

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)

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)

Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)

Full Information

NCT ID

NCT04911582

First Posted

May 27, 2021

Last Updated

February 25, 2022

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04911582

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

May 25, 2021 (Actual)

Primary Completion Date

September 16, 2021 (Actual)

Study Completion Date

September 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Abdominal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cafestol 6 mg

Arm Type

Active Comparator

Arm Description

6 mg cafestol

Arm Title

Cafestol 12 mg

Arm Type

Active Comparator

Arm Description

12 mg cafestol

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Cafestol 12 mg

Intervention Description

Capsule with 12 mg cafestol

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo capsule without cafestol

Intervention Type

Dietary Supplement

Intervention Name(s)

Cafestol 6 mg

Intervention Description

Capsule with 6 mg cafestol

Primary Outcome Measure Information:

Title

Area under the curve for glucose

Description

Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule (mmol/L)

Time Frame

-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

Secondary Outcome Measure Information:

Title

Area under the curve for insulin-response

Description

Area under the curve for insulin response during OGTT after ingestion of cafestol or placebo capsule (pmol/L)

Time Frame

-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

Title

Area under the curve for cafestol

Description

Area under the curve for cafestol during OGTT after ingestion of cafestol or placebo capsule

Time Frame

-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

Title

Area under the curve for GLP-1 (glucagon-like peptide-1)

Description

Area under the curve for GLP-1 (glucagon-like peptide-1) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)

Time Frame

-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

Title

Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide)

Description

Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)

Time Frame

-15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Steno Diabetes Center Aarhus

City

Aarhus

State/Province

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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