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The Effect of Curcumin on Liver Fat Content in Obese Subjects

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ClinicalTrials.gov Identifier: NCT03864783
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborators:
University of Copenhagen
University of Aarhus
Herlev and Gentofte Hospital
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

Brief Summary:

The majority of obese have non-alcoholic fatty liver disease (NALFD). Currently, no pharmacological agents are licenced for the prevention or treatment of NAFLD, and weight loss, notoriously difficult to obtain (and specially to maintain), remains the only treatment option. Interestingly, curcumin, a phenolic compound extracted from the turmeric root, has from in vitro and animal studies shown promising effects in preventing and treating NAFLD, and the sparse available human data point in the same direction; but solid human data are missing. This study will delineate the effects of curcumin when treating NAFLD in humans.

The primary aim of this study is to investigate the effect of 6 weeks of curcumin on liver fat content (assessed by magnetic resonance spectroscopy (MRS)) in obese subject with NAFLD. Additionally, a range of secondary endpoints have been chosen in order to delineate the role of NAFLD in the newly discovered liver-alpha cell axis governing circulating levels of the glucose-mobilising pancreatic alpha cell hormone glucagon and, thus, to elucidate the link between liver fat content and the risk of developing reduced glucose tolerance and type 2 diabetes (T2D). Also, the anti-inflammatory effect of curcumin will be elucidated, as inflammatory markers will be measured before and after intervention. Furthermore, the effect of curcumin will be measured by measuring the following parameters before and after intervention: Transient elastography, anthropometric measurements, body weight, appetite, food-consumption, calory balance, resting energy expenditure, gut microbiota, bioimpedance measures, visceral- and subcutaneous fat, glucose tolerance, lipids, blood pressure, pulse, liver parameters (blood-tests) and adipokines. During the oral glucose tolerance test before and after intervention, incretin hormones, glucagon, amino acids, insulin, c-peptide and urea will be measured.


Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease Insulin Resistance Glucose Tolerance Impaired Obesity, Abdominal Dietary Supplement: Curcumin (Meriva®) Drug: Placebo Oral Tablet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Curcumin on Liver Fat Content in Obese Subjects
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Curcumin (Meriva®)
Meriva® 500 mg tablet (contains 100 mg curcumin) Dosage: 2 tablets twice daily for 42 days (+/- 3 days)
Dietary Supplement: Curcumin (Meriva®)

Experimental drug:

Meriva® 500 mg tablet (contains 1 mg curcumin)


Placebo Comparator: Placebo
Placebo. Dosage: 2 tablets twice daily to mimic Meriva® tablets.
Drug: Placebo Oral Tablet

Placebo:

Contains same ingredients as Meriva®, apart from curcumin. Similar in appearance to Meriva®.





Primary Outcome Measures :
  1. Curcumin's effect on steatosis [ Time Frame: 42 days +/- 3 days ]
    Percentage of fat in the liver tissue measured by magnetic resonance spectroscopy


Secondary Outcome Measures :
  1. Curcumin's effect on concentration of total amino acids in plasma [ Time Frame: 42 days +/- 3 days ]
  2. Curcumin's effect on plasma concentration of urea [ Time Frame: 42 days +/- 3 days ]
  3. Curcumin's effect on urin concentration of urea [ Time Frame: 42 days +/- 3 days ]
  4. Curcumin's effect on serum concentration of inflammatory marker interleukin (IL)-1b [ Time Frame: 42 days +/- 3 days ]
  5. Curcumin's effect on serum concentration of inflammatory marker IL-2 [ Time Frame: 42 days +/- 3 days ]
  6. Curcumin's effect on serum concentration of inflammatory marker IL-6 [ Time Frame: 42 days +/- 3 days ]
  7. Curcumin's effect on serum concentration of inflammatory marker IL-10 [ Time Frame: 42 days +/- 3 days ]
  8. Curcumin's effect on serumconcentration of inflammatory marker tumor necrosis factor (TNF)-alpha [ Time Frame: 42 days +/- 3 days ]
  9. Curcumin's effect on plasma concentration of adipokines [ Time Frame: 42 days +/- 3 days ]
  10. Curcumin's effect on plasma concentration of glucagon [ Time Frame: 42 days +/- 3 days ]
  11. Curcumin's effect on plasma concentration of glucagon-like peptide 1 [ Time Frame: 42 days +/- 3 days ]
  12. Curcumin's effect on plasma concentration of glucose-dependent insulinotropic peptide [ Time Frame: 42 days +/- 3 days ]
  13. Curcumin's effect on glucose plasma values during an oral glucose tolerance test for 4 hours [ Time Frame: 42 days +/- 3 days ]
  14. Curcumin's effect on serum c-peptide levels [ Time Frame: 42 days +/- 3 days ]
  15. Curcumin's effect on serum insulin concentration [ Time Frame: 42 days +/- 3 days ]
  16. Curcumin's effect on serum concentration of free fatty acids [ Time Frame: 42 days +/- 3 days ]
  17. Curcumin's effect on liver insulin resistance [ Time Frame: 42 days +/- 3 days ]
  18. Curcumin's effect on body weight in kilograms [ Time Frame: 42 days +/- 3 days ]
  19. Curcumin's effect on BMI (kg/m^2) [ Time Frame: 42 days +/- 3 days ]
  20. Curcumin's effect on waist circumference (cm) [ Time Frame: 42 days +/- 3 days ]
  21. Curcumin's effect on waist-hip ratio [ Time Frame: 42 days +/- 3 days ]
  22. Curcumin's effect on systolic blood pressure (mmHg) [ Time Frame: 42 days +/- 3 days ]
  23. Curcumin's effect on diastolic blood pressure (mmHg) [ Time Frame: 42 days +/- 3 days ]
  24. Curcumin's effect on transient elastography liver stiffness measurements (kPa) [ Time Frame: 42 days +/- 3 days ]
    Evaluated with FibroScan

  25. Curcumin's effect on transient elastography controlled attenuation parameter (CAP) value (dB/m) [ Time Frame: 42 days +/- 3 days ]
    Evaluated with FibroScan

  26. Curcumin's effect on gut microbiota (relative abundance) [ Time Frame: 42 days +/- 3 days ]
  27. Curcumin's effect on gut microbiota (alpha/beta diversity) [ Time Frame: 42 days +/- 3 days ]
  28. Curcumin's effect on gut microbiota (link to phenotype of interest) [ Time Frame: 42 days +/- 3 days ]
  29. Curcumin's effect on visceral fat (cm) [ Time Frame: 42 days +/- 3 days ]
    Evaluated by MR-spectroscopy

  30. Curcumin's effect on subcutaneous fat (cm) [ Time Frame: 42 days +/- 3 days ]
    Evaluated by MR-spectroscopy

  31. Curcumin's effect on muscle percentage [ Time Frame: 42 days +/- 3 days ]
    Evaluated by bioimpedance measurement

  32. Curcumin's effect on fatt mass [ Time Frame: 42 days +/- 3 days ]
    Evaluated by bioimpedance measurement

  33. Curcumin's effect on fat percentage [ Time Frame: 42 days +/- 3 days ]
    Evaluated by bioimpedance measurement

  34. Curcumin's effect on fat-free mass [ Time Frame: 42 days +/- 3 days ]
    Evaluated by bioimpedance measurement

  35. Curcumin's effect on fat-free mass percentage [ Time Frame: 42 days +/- 3 days ]
    Evaluated by bioimpedance measurement

  36. Curcumin's effect on total body water [ Time Frame: 42 days +/- 3 days ]
    Evaluated by bioimpedance measurement

  37. Curcumin's effect on body water percentage [ Time Frame: 42 days +/- 3 days ]
    Evaluated by bioimpedance measurement

  38. Curcumin's effect on prospective food consumption [ Time Frame: 42 days +/- 3 days ]
    Evaluated by questionnaires during the OGTT on the experimental days

  39. Curcumin's effect on food consumption [ Time Frame: 42 days +/- 3 days ]
    Evaluated by how many grams of standardised meal the subject eats at an ad libitum meal

  40. Curcumin's effect on calory balance [ Time Frame: 42 days +/- 3 days ]
    Evaluated by a questionnaire participants fill out on 3 consecutive days

  41. Curcumin's effect on plasma concentration of cholesterol [ Time Frame: 42 days +/- 3 days ]
  42. Curcumin's effect on plasma concentration of alanine aminotransferase [ Time Frame: 42 days +/- 3 days ]
  43. Curcumin's effect on plasma concentration of aspartate aminotransferase [ Time Frame: 42 days +/- 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >30.0 kg/m2
  • Haemoglobin ≥7.5 mmol/l
  • Written informed consent
  • If the subject is known with diet treated diabetes, HbA1c has to be < 48 mmol/mol.
  • If the subject is not known diabetes, HbA1c can be <53 mmol/mol

Two of the following four parameters:

  • Steatosis on Fibro scan with M-probe or XL-probe (S>=1)
  • Waist circumference >94 cm
  • HbA1c>48 mmol/mol
  • FLI score >60% (see enclosure 2 "FLI score")

Exclusion Criteria:

  • Use of glucose-lowering drugs, lipid-lowering drugs, warfarin, clopidogrel or non-vitamin K oral anticoagulants
  • Treatment with drugs with potential steatogenic side-effects within three months prior to inclusion (e.g. tetracycline, valproic acid, systemic glucocorticoids, amiodarone, tamoxifen and methotrexate)
  • Known viral, inherited or alcoholic liver disease, or any other condition known to affect the liver (e.g. coeliac disease, Wilsons disease, cystic fibrosis, alpha-1 anti-trypsin deficiency)
  • Positive result of blood test for viral hepatitis markers
  • Intake of more than 21 units of alcohol per week, or earlier alcohol abuse
  • Frequent use of anti-inflammatory drugs
  • Nephropathy (eGFR < 60 ml/min/1.73 m² and/or urine albumin > 20 mg/L)
  • In a weight management program, or planning to change life style, alcohol habits or eating habits during the study
  • Known allergy to curcumin/turmeric
  • Claustrophobia
  • Implanted metal objects contraindicative of MRS
  • Any condition(s) or clinical or biochemical signs that the investigator think would interfere with trial participation or with the safety of the subject
  • Any regular drug treatment that cannot be discontinued for minimum 18 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864783


Contacts
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Contact: Pernille H Hellmann, MD +45 20911792 pernille.hoegh.hellmann@regionh.dk
Contact: Filip K Knop, MD, PhD +45 26830161 filip.krag.knop.01@regionh.dk

Locations
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Denmark
Center for Clinical Metabolic Research Recruiting
Hellerup, Denmark, 2900
Contact: Pernille H Hellmann, MD    +45 20911792    pernille.hoegh.hellmann@regionh.dk   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
University of Copenhagen
University of Aarhus
Herlev and Gentofte Hospital
Investigators
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Principal Investigator: Pernille H Hellmann, MD Center for Clinical Metabolic Research, Gentofte Hospital

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Responsible Party: Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT03864783     History of Changes
Other Study ID Numbers: H-18045227
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Insulin Resistance
Obesity, Abdominal
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Obesity
Overnutrition
Nutrition Disorders
Hyperglycemia
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action