Obesity, AbdominalNCT05672433
Long-term Metabolic Effects of Cafestol
A study testing Cafestol in people with Obesity, Abdominal, run by University of Aarhus at 1 site in Denmark.
Trial summary
Twelve-week double-blinded, placebo-controlled, parallel intervention study on 40 participants with a large waist circumference who will ingest cafestol or placebo capsules twice daily. Insulin resistance is measured before and after the twelve-week intervention. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Jun 2022to 1 Mar 2023
- 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
- 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? (Long-term Substudy)
Twelve-week double-blinded, placebo-controlled, parallel intervention study on 40 participants with a large waist circumference who will ingest cafestol or placebo capsules twice daily. Insulin resistance is measured before and after the twelve-week intervention.
Read the detailed description
Participants are randomly allocated to the cafestol intervention group or placebo group. Before and after the twelve-week intervention the participants partake in:
- A modified two-stage Insulin Suppression Test to determine insulin mediated glucose uptake. Fasting participants receive body-surface-area-adjusted octreotide, insulin and glucose infusions for 240 minutes. Octreotide is infused with the same rate throughout the test. Insulin and glucose infusions are slow for the initial 120-minute stage and increased the final 120-minute stage, simulating fasting and post-postprandial conditions, respectively. Steady state measurements of plasma glucose are acquired the final 30 minutes of each stage, at time points 100, 110, 120, 220, 230 and 240 minutes.
- A mixed meal test. Fasting participants consume 75 g. white bread, 10 g. butter, 30 g. cheese and 200 ml. orange juice. Blood samples are drawn at time points -15, 0, 15, 30, 60, 90, 120, 180 and 240 min for glucose-, insulin-, glucagon- and triglyceride measurements.
- A Magnetic Resonance Imaging (MRI) scan. Participants undergo dixon-sequences scanning the abdomen, assessing visceral and sub-cutaneous fat volume and liver fat content. Magnetic Resonance (MR) spectroscopy is also used to determine fat percentage of the liver.
- 24-hour ambulatory blood pressure measurement, every 20 minutes during daytime and every 30 minutes during nighttime.
- 1-week continuous glucose measurement using blinded continuous glucose monitor/sensor on upper arm.
- Fecal and urine sampling
- 72-hour food-diary
- Fasting blood samples:
- Insulin, c-peptide, HbA1c and glucose
- Total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglycerides
- Thyroid-stimulating hormone (TSH)
- Alanine aminotransferase, creatinine, sodium and potassium
- High sensitivity C reactive protein (CRP) and alpha-hydroxybutyrate
- C-terminal telopeptide (CTX) and Procollagen type 1 N-terminal propeptide (P1NP)
- Parathyroid hormone (PTH), Vitamin D and Ionized calcium
- Monocyte Chemoattractant Protein-1 (MCP-1)
- Interleukin 1 \& 8 (IL-1α, IL-1β, IL-8)
- Gastric inhibitory polypeptide (GIP), Glucagon-like peptide-1 (GLP-1) and Glucagon- like peptide-2 (GLP-2)
- Growth/differentiation factor 15 (GDF-15)
- Tumor necrosis factor (TNFα)
- Fasting assessment of insulin resistance (Homeostatic Model Assessment for Insulin Resistance by C-peptide).
Pre-intervention and end-intervention test results will be compared using repeated-measures ANOVA / mixed models.
- Conditions
- Obesity, Abdominal
- Being tested
- Placebo, Cafestol
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Capsule without cafestol twice daily
CafestolDietary supplement
Capsule with 6 mg cafestol twice daily
| Study group | Role | What they receive |
|---|---|---|
| Cafestol | Active comparator | Participants in this arm ingest 6 mg cafestol capsules twice daily with breakfast and dinner. Receives: Dietary Supplement: Cafestol |
| Placebo | Placebo comparator | Participants in this arm ingest placebo capsules twice daily with breakfast and dinner. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state plasma glucose during stage 2 of insulin suppression test (mmol/L)
Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 milliunits (mU) insulin / m2 • minute, and 50 mg glucose / m2 • minute. At time-point 120 minutes, infusion speeds were increased to to 32 mU insulin / m2 • minute and 267 mg glucose / m2 • minute.
Measured: 220, 230 and 240 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.
Steady state plasma glucose during stage 1 of insulin suppression test (mmol/L)
Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 mU insulin / m2 • minute, and 50 mg glucose / m2 • min.
Measured: 100, 110 and 120 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.
Area under the curve for glucose during mixed meal test (mmol/L*min)
Area under the curve for glucose during a mixed meal test.
Measured: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Secondary outcomes (10)
Area under the curve for insulin during mixed meal test (pmol/L*min)
Area under the curve for insulin during a mixed meal test.
Measured: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for glucagon during mixed meal test (pmol/L*min)
Area under the curve for glucagon during a mixed meal test.
Measured: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for triglycerides during mixed meal test (mmol/L*min)
Area under the curve for triglycerides during a mixed meal test.
Measured: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Glycated hemoglobin (HbA1c) (mmol/mol)
Glycated hemoglobin (HbA1c) (mmol/mol)
Measured: 12-week change. Comparison between pre-intervention and end-intervention glycated hemoglobin levels.
Liver fat content (%)
Measured with dixon-sequences scanning the abdomen and MR-Spectroscopy.
Measured: 12-week change. Comparison between pre-intervention scan and end-intervention scan.
Visceral fat content (ml)
Measured with dixon-sequences scanning the abdomen
Measured: 12-week change. Comparison between pre-intervention scan and end-intervention scan.
Subcutaneous fat content (ml)
Measured with dixon-sequences scanning the abdomen
Measured: 12-week change. Comparison between pre-intervention scan and end-intervention scan.
One-week continuous glucose measurement
One-week continuous glucose measurement data.
Measured: Average glucose measured every 15 minutes for one week prior to study day 1 and 3. 12-week change. Comparison between pre-intervention measurement and end-intervention measurement.
Blood pressure (mmHg)
Average daytime and night-time ambulatory blood pressure. 24-hour ambulatory blood pressure measurement, measured every 20 minutes during daytime and every 30 minutes during nighttime.
Measured: 12-week change. Comparison between pre-intervention average ambulatory blood pressure and end-intervention average ambulatory blood pressure.
Food consumption in kilocalories (kcal)
Food consumption is registered for 72-hours prior to study day 1 and 3. Food consumption is measured in kilocalories (kcal).
Measured: 12-week change. Comparison between pre-intervention food consumption and end-intervention food consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start28 Jun 2022
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Søren Gregersen, M.D. Ph.D, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672433
- Sponsor's protocol ID
- cafestol.longterm
- Status last verified
- Jun 2022
- First submitted
- 2 Dec 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. 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? (Long-term Substudy)
- ClinicalTrials.gov ID
- NCT05672433
- Acronym / sponsor ID
- cafestol.longterm
- Conditions
- Obesity, Abdominal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 5 Jan 2023 (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.
Twelve-week double-blinded, placebo-controlled, parallel intervention study on 40 participants with a large waist circumference who will ingest cafestol or placebo capsules twice daily. Insulin resistance is measured before and after the twelve-week intervention.
Detailed description
Participants are randomly allocated to the cafestol intervention group or placebo group. Before and after the twelve-week intervention the participants partake in:
- A modified two-stage Insulin Suppression Test to determine insulin mediated glucose uptake. Fasting participants receive body-surface-area-adjusted octreotide, insulin and glucose infusions for 240 minutes. Octreotide is infused with the same rate throughout the test. Insulin and glucose infusions are slow for the initial 120-minute stage and increased the final 120-minute stage, simulating fasting and post-postprandial conditions, respectively. Steady state measurements of plasma glucose are acquired the final 30 minutes of each stage, at time points 100, 110, 120, 220, 230 and 240 minutes.
- A mixed meal test. Fasting participants consume 75 g. white bread, 10 g. butter, 30 g. cheese and 200 ml. orange juice. Blood samples are drawn at time points -15, 0, 15, 30, 60, 90, 120, 180 and 240 min for glucose-, insulin-, glucagon- and triglyceride measurements.
- A Magnetic Resonance Imaging (MRI) scan. Participants undergo dixon-sequences scanning the abdomen, assessing visceral and sub-cutaneous fat volume and liver fat content. Magnetic Resonance (MR) spectroscopy is also used to determine fat percentage of the liver.
- 24-hour ambulatory blood pressure measurement, every 20 minutes during daytime and every 30 minutes during nighttime.
- 1-week continuous glucose measurement using blinded continuous glucose monitor/sensor on upper arm.
- Fecal and urine sampling
- 72-hour food-diary
- Fasting blood samples:
- Insulin, c-peptide, HbA1c and glucose
- Total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglycerides
- Thyroid-stimulating hormone (TSH)
- Alanine aminotransferase, creatinine, sodium and potassium
- High sensitivity C reactive protein (CRP) and alpha-hydroxybutyrate
- C-terminal telopeptide (CTX) and Procollagen type 1 N-terminal propeptide (P1NP)
- Parathyroid hormone (PTH), Vitamin D and Ionized calcium
- Monocyte Chemoattractant Protein-1 (MCP-1)
- Interleukin 1 \& 8 (IL-1α, IL-1β, IL-8)
- Gastric inhibitory polypeptide (GIP), Glucagon-like peptide-1 (GLP-1) and Glucagon- like peptide-2 (GLP-2)
- Growth/differentiation factor 15 (GDF-15)
- Tumor necrosis factor (TNFα)
- Fasting assessment of insulin resistance (Homeostatic Model Assessment for Insulin Resistance by C-peptide).
Pre-intervention and end-intervention test results will be compared using repeated-measures ANOVA / mixed models.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cafestol | Active comparator | Dietary Supplement: CafestolParticipants in this arm ingest 6 mg cafestol capsules twice daily with breakfast and dinner. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm ingest placebo capsules twice daily with breakfast and dinner. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 |
|---|---|---|
| PlaceboCapsule without cafestol twice daily | Dietary supplement | Placebo |
| CafestolCapsule with 6 mg cafestol twice daily | Dietary supplement | Cafestol |
Primary outcome
Steady state plasma glucose during stage 2 of insulin suppression test (mmol/L)
Time frame: 220, 230 and 240 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.
Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 milliunits (mU) insulin / m2 • minute, and 50 mg glucose / m2 • minute. At time-point 120 minutes, infusion speeds were increased to to 32 mU insulin / m2 • minute and 267 mg glucose / m2 • minute.
Steady state plasma glucose during stage 1 of insulin suppression test (mmol/L)
Time frame: 100, 110 and 120 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.
Subjects are administered a 25 μg octreotide bolus at time-point 0 minutes and subsequently infused with 0.27 μg octreotide / m2 • minute, 6 mU insulin / m2 • minute, and 50 mg glucose / m2 • min.
Area under the curve for glucose during mixed meal test (mmol/L*min)
Time frame: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for glucose during a mixed meal test.
10 secondary outcomes
Area under the curve for insulin during mixed meal test (pmol/L*min)
Time frame: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for glucagon during mixed meal test (pmol/L*min)
Time frame: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Area under the curve for triglycerides during mixed meal test (mmol/L*min)
Time frame: -15 to 240 minutes from ingestion of standardized meal at time point 0 minutes. Comparison between pre-intervention and end-intervention area under the curves.
Glycated hemoglobin (HbA1c) (mmol/mol)
Time frame: 12-week change. Comparison between pre-intervention and end-intervention glycated hemoglobin levels.
Liver fat content (%)
Time frame: 12-week change. Comparison between pre-intervention scan and end-intervention scan.
Visceral fat content (ml)
Time frame: 12-week change. Comparison between pre-intervention scan and end-intervention scan.
Subcutaneous fat content (ml)
Time frame: 12-week change. Comparison between pre-intervention scan and end-intervention scan.
One-week continuous glucose measurement
Time frame: Average glucose measured every 15 minutes for one week prior to study day 1 and 3. 12-week change. Comparison between pre-intervention measurement and end-intervention measurement.
Blood pressure (mmHg)
Time frame: 12-week change. Comparison between pre-intervention average ambulatory blood pressure and end-intervention average ambulatory blood pressure.
Food consumption in kilocalories (kcal)
Time frame: 12-week change. Comparison between pre-intervention food consumption and end-intervention food consumption.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Søren Gregersen, M.D. Ph.D principal investigator
Aarhus University Hospital
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 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: status not confirmed, as of the sponsor's last update on 5 Jan 2023. 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?
Results are not available in the source record.
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?
Steady state plasma glucose during stage 2 of insulin suppression test (mmol/L) (time frame: 220, 230 and 240 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.). The study lists 3 primary outcomes in all. 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 5 Jan 2023.