Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05672433
Status:
UNKNOWN
Last Update Posted:
2023-01-05
First Post:
2022-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Metabolic Effects of Cafestol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053400', 'term': 'cafestol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2022-12-02', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fasting glucose (mmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting insulin (pmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting total cholesterol (mmol/l),', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting HDL (mmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting LDL (mmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting triglycerides (mmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting thyroid-stimulating hormone (international unit (IU)/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting alanine aminotransferase (unit(U)/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting high sensitivity c reactive protein (mg/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting alpha-hydroxybutyrate (mmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting C-terminal telopeptide (µg/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting procollagen type 1 N-terminal propeptide (µg/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting parathyroid hormone (pmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting vitamin D (nmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting ionized calcium (mmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting monocyte chemoattractant protein-1 (pg/ml)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting interleukin 1 (pg/ml)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting interleukin 8 (pg/ml)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting gastric inhibitory polypeptide (pmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting glucagon-like peptide-2 (pmol/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting growth/differentiation factor 15 (ng/l)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting tumor necrosis factor (TNFα)', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}, {'measure': 'Fasting Homeostatic Model Assessment for Insulin Resistance by C-peptide (arbitrary unit).', 'timeFrame': 'Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.'}], 'primaryOutcomes': [{'measure': 'Steady state plasma glucose during stage 2 of insulin suppression test (mmol/L)', 'timeFrame': '220, 230 and 240 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.', 'description': '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.'}, {'measure': 'Steady state plasma glucose during stage 1 of insulin suppression test (mmol/L)', 'timeFrame': '100, 110 and 120 minutes after test-start. Comparison between pre-intervention and end-intervention steady state plasma glucose.', 'description': '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.'}, {'measure': 'Area under the curve for glucose during mixed meal test (mmol/L*min)', 'timeFrame': '-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.', 'description': 'Area under the curve for glucose during a mixed meal test.'}], 'secondaryOutcomes': [{'measure': 'Area under the curve for insulin during mixed meal test (pmol/L*min)', 'timeFrame': '-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.', 'description': 'Area under the curve for insulin during a mixed meal test.'}, {'measure': 'Area under the curve for glucagon during mixed meal test (pmol/L*min)', 'timeFrame': '-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.', 'description': 'Area under the curve for glucagon during a mixed meal test.'}, {'measure': 'Area under the curve for triglycerides during mixed meal test (mmol/L*min)', 'timeFrame': '-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.', 'description': 'Area under the curve for triglycerides during a mixed meal test.'}, {'measure': 'Glycated hemoglobin (HbA1c) (mmol/mol)', 'timeFrame': '12-week change. Comparison between pre-intervention and end-intervention glycated hemoglobin levels.', 'description': 'Glycated hemoglobin (HbA1c) (mmol/mol)'}, {'measure': 'Liver fat content (%)', 'timeFrame': '12-week change. Comparison between pre-intervention scan and end-intervention scan.', 'description': 'Measured with dixon-sequences scanning the abdomen and MR-Spectroscopy.'}, {'measure': 'Visceral fat content (ml)', 'timeFrame': '12-week change. Comparison between pre-intervention scan and end-intervention scan.', 'description': 'Measured with dixon-sequences scanning the abdomen'}, {'measure': 'Subcutaneous fat content (ml)', 'timeFrame': '12-week change. Comparison between pre-intervention scan and end-intervention scan.', 'description': 'Measured with dixon-sequences scanning the abdomen'}, {'measure': 'One-week continuous glucose measurement', 'timeFrame': '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.', 'description': 'One-week continuous glucose measurement data.'}, {'measure': 'Blood pressure (mmHg)', 'timeFrame': '12-week change. Comparison between pre-intervention average ambulatory blood pressure and end-intervention average ambulatory blood pressure.', 'description': '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.'}, {'measure': 'Food consumption in kilocalories (kcal)', 'timeFrame': '12-week change. Comparison between pre-intervention food consumption and end-intervention food consumption.', 'description': 'Food consumption is registered for 72-hours prior to study day 1 and 3. Food consumption is measured in kilocalories (kcal).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Abdominal']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Participants are randomly allocated to the cafestol intervention group or placebo group. Before and after the twelve-week intervention the participants partake in:\n\n* 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.\n* 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.\n* 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.\n* 24-hour ambulatory blood pressure measurement, every 20 minutes during daytime and every 30 minutes during nighttime.\n* 1-week continuous glucose measurement using blinded continuous glucose monitor/sensor on upper arm.\n* Fecal and urine sampling\n* 72-hour food-diary\n* Fasting blood samples:\n\n * Insulin, c-peptide, HbA1c and glucose\n * Total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglycerides\n * Thyroid-stimulating hormone (TSH)\n * Alanine aminotransferase, creatinine, sodium and potassium\n * High sensitivity C reactive protein (CRP) and alpha-hydroxybutyrate\n * C-terminal telopeptide (CTX) and Procollagen type 1 N-terminal propeptide (P1NP)\n * Parathyroid hormone (PTH), Vitamin D and Ionized calcium\n * Monocyte Chemoattractant Protein-1 (MCP-1)\n * Interleukin 1 \\& 8 (IL-1α, IL-1β, IL-8)\n * Gastric inhibitory polypeptide (GIP), Glucagon-like peptide-1 (GLP-1) and Glucagon- like peptide-2 (GLP-2)\n * Growth/differentiation factor 15 (GDF-15)\n * Tumor necrosis factor (TNFα)\n * Fasting assessment of insulin resistance (Homeostatic Model Assessment for Insulin Resistance by C-peptide).\n\nPre-intervention and end-intervention test results will be compared using repeated-measures ANOVA / mixed models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWaist circumference \\> 102 cm (men) / 88 cm (women)\n\nExclusion Criteria:\n\n* Type 2 diabetes (HbA1c \\> 48 mmol/mol) or in treatment with antidiabetic drugs\n* Pregnancy\n* Planned pregnancy\n* Breastfeeding\n* Significant comorbidity expected to unable the subject from completing visits'}, 'identificationModule': {'nctId': 'NCT05672433', 'briefTitle': 'Long-term Metabolic Effects of Cafestol', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Does the Bioactive Substance in Coffee, Cafestol, Have Preventive Properties on Type-2-diabetes? (Long-term Substudy)', 'orgStudyIdInfo': {'id': 'cafestol.longterm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cafestol', 'description': 'Participants in this arm ingest 6 mg cafestol capsules twice daily with breakfast and dinner.', 'interventionNames': ['Dietary Supplement: Cafestol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm ingest placebo capsules twice daily with breakfast and dinner.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule without cafestol twice daily', 'armGroupLabels': ['Placebo']}, {'name': 'Cafestol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule with 6 mg cafestol twice daily', 'armGroupLabels': ['Cafestol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Aarhus N', 'country': 'Denmark', 'facility': 'Steno Diabetes Center Aarhus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Søren Gregersen, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}