Long-term Metabolic Effects of Cafestol

NCT05672433 | Unknown

• 1 other identifier: cafestol.longterm
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Abdominal

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  -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)

  -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)

  -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)

  -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)

  12-week change. Comparison between pre-intervention and end-intervention glycated hemoglobin levels.

• Liver fat content (%)

  12-week change. Comparison between pre-intervention scan and end-intervention scan.

Other Outcomes (23)

• Fasting glucose (mmol/l)

  Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.

• Fasting insulin (pmol/l)

  Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.

• Fasting total cholesterol (mmol/l),

  Measured on study day 1 and 3. 12-week change. Comparison between pre-intervention blood samples and end-intervention blood samples.

Study Arms (2)

Cafestol

ACTIVE COMPARATOR

Participants in this arm ingest 6 mg cafestol capsules twice daily with breakfast and dinner.

Dietary Supplement: Cafestol

Placebo

PLACEBO COMPARATOR

Participants in this arm ingest placebo capsules twice daily with breakfast and dinner.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Capsule without cafestol twice daily

Placebo

Cafestol DIETARY_SUPPLEMENT

Capsule with 6 mg cafestol twice daily

Cafestol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Waist circumference \> 102 cm (men) / 88 cm (women)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

cafestol

Condition Hierarchy (Ancestors)

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

Study Officials

• Søren Gregersen, M.D. Ph.D

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: January 5, 2023
• Study Start: June 28, 2022
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 5, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)