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NCT Number: NCT04911582

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

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

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Key information

Conditions

Obesity, Abdominal Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Aarhus

Aarhus, Aarhus N, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cafestol 12 mg

Dietary Supplement

Capsule with 12 mg cafestol

Placebo

Dietary Supplement

Placebo capsule without cafestol

Cafestol 6 mg

Dietary Supplement

Capsule with 6 mg cafestol

Primary outcomes

  1. Area under the curve for glucose

    Time frame: -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 outcomes

  1. Area under the curve for insulin-response

    Time frame: -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)

  2. Area under the curve for cafestol

    Time frame: -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

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

    Time frame: -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)

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

    Time frame: -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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 3, 2021
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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