Obesity, AbdominalNCT04911582
Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? (Acute Substudy)
A study testing Cafestol 12 mg and Cafestol 6 mg in people with Obesity, Abdominal, run by University of Aarhus at 1 site in Denmark.
Trial summary
Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Cafestol 12 mg and Cafestol 6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 25 May 2021to 16 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25 < BMI < 40 kg/m2 Waist circumference > 102 cm (men) / 88 cm (women)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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)
Acute, double-blinded, randomized, cross-over cafestol intervention study with fifteen participants with a large waist circumference participating in three OGTTs.
Read the 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.
- Conditions
- Obesity, Abdominal
- Being tested
- Cafestol 12 mg, Placebo, Cafestol 6 mg
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cafestol 12 mgDietary supplement
Capsule with 12 mg cafestol
PlaceboDietary supplement
Placebo capsule without cafestol
Cafestol 6 mgDietary supplement
Capsule with 6 mg cafestol
| Study group | Role | What they receive |
|---|---|---|
| Cafestol 6 mg | Active comparator | 6 mg cafestol Receives: Dietary Supplement: Cafestol 6 mg |
| Cafestol 12 mg | Active comparator | 12 mg cafestol Receives: Dietary Supplement: Cafestol 12 mg |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for glucose
Area under the curve for glucose during OGTT after ingestion of cafestol or placebo capsule (mmol/L)
Measured: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Secondary outcomes (4)
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)
Measured: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Area under the curve for cafestol
Area under the curve for cafestol during OGTT after ingestion of cafestol or placebo capsule
Measured: -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)
Area under the curve for GLP-1 (glucagon-like peptide-1) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)
Measured: -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)
Area under the curve for GIP (Glucose-dependent insulinotropic polypeptide) during OGTT after ingestion of cafestol or placebo capsule (pmol/L)
Measured: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start25 May 2021
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911582
- Sponsor's protocol ID
- cafestol.acute.waist
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04911582
- Acronym / sponsor ID
- cafestol.acute.waist
- Conditions
- Obesity, Abdominal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 25 May 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cafestol 6 mg | Active comparator | Dietary Supplement: Cafestol 6 mg6 mg cafestol |
| Cafestol 12 mg | Active comparator | Dietary Supplement: Cafestol 12 mg12 mg cafestol |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 25 < BMI < 40 kg/m2 Waist circumference > 102 cm (men) / 88 cm (women)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cafestol 12 mgCapsule with 12 mg cafestol | Dietary supplement | Cafestol 12 mg |
| PlaceboPlacebo capsule without cafestol | Dietary supplement | Placebo |
| Cafestol 6 mgCapsule with 6 mg cafestol | Dietary supplement | Cafestol 6 mg |
Primary outcome
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)
4 secondary outcomes
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 cafestol
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)
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)
Time frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cafestol 12 mg and Cafestol 6 mg in people with Obesity, Abdominal, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve for glucose (time frame: -15 to 180 minutes from ingestion of intervention/placebo capsule and 75 g. glucose solution). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.