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Mitochondrial Effects of C18:0 Supplementation in Humans

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ClinicalTrials.gov Identifier: NCT02957838
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
German Cancer Research Center
Information provided by (Responsible Party):
Daniel Pfaff, University Hospital Heidelberg

Brief Summary:
The purpose of this crossover study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet and will then be supplemented with a bolus of C18:0. Changes in the mitochondrial morphology and function of white blood cells will be scored by immunofluorescence and FACS analysis.

Condition or disease Intervention/treatment Phase
Alteration of Mitochondrial Membrane Type2 Diabetes Fatty Acid Deficiency Dietary Supplement: C18:0 Dietary Supplement: mock Not Applicable

Detailed Description:
The purpose of this study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet to reach baseline levels of C18:0 and will then be fed a milkshake supplemented with 24g of C18:0, which corresponds roughly to the C18:0 content of a fast-food meal. Blood samples will be taken at baseline and several hours after intake. We will look at changes in mitochondrial morphology of neutrophils by immunofluorescence, and score mitochondrial function via FACS analysis. Since this study is designed as a crossover study, participants will also receive a mock milk shake after another 2 days of low-fat vegan diet.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Mitochondrial Effects of C18:0 Supplementation in Type 2 Diabetics Versus Healthy Controls
Study Start Date : November 2016
Actual Primary Completion Date : October 6, 2017
Actual Study Completion Date : November 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non-diabetics
Non-diabetic volunteers with HbA1c < 6.5%. Subjects will be treated with C18:0 supplementation or mock.
Dietary Supplement: C18:0
Receives 24g of C18:0 in a low-fat banana milkshake.
Other Names:
  • stearic acid
  • stearic acid, Sigma-Aldrich, product number W303518

Dietary Supplement: mock
Low fat banana milkshake without C18:0 supplement.

Experimental: Type 2 Diabetics
Type 2 Diabetes according to common definitions, but we exclude insulin-treated Type 2 diabetics because nutritional intervention is more difficult/risky. Subjects will be treated with C18:0 supplementation or mock.
Dietary Supplement: C18:0
Receives 24g of C18:0 in a low-fat banana milkshake.
Other Names:
  • stearic acid
  • stearic acid, Sigma-Aldrich, product number W303518

Dietary Supplement: mock
Low fat banana milkshake without C18:0 supplement.




Primary Outcome Measures :
  1. Changes in Mitochondrial Morphology [ Time Frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h ]
    Mitochondria of neutrophils are stained and scored via immunofluorescence microcsopy, either as "fragmented", "intermediate" or "fused". Statistical calculations will be performed on changes in fragmentation status after treatment.

  2. Changes in Mitochondrial Function [ Time Frame: on the day of supplementation at 0, 3 and 6 h ]
    Mitochondrial membrane potential and ROS production in neutrophils will be analyzed via FACS. Statistical calculations will be performed on changes in the respective levels after treatment.


Secondary Outcome Measures :
  1. plasma iron, transferrin, ferritin, ferroportin and hepcidin levels [ Time Frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h ]
    Measurement of iron, transferrin, ferritin, hepcidin and ferroportin from serum at all timepoints via ELISA. Changes in plasma levels will be correlated to primary endpoints.

  2. plasma methylglyoxal levels [ Time Frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h ]
    Methylglyoxal levels in plasma analyzed via liquid chromatography-mass spectrometry. Changes will be correlated to primary endpoints.

  3. plasma fatty acid levels [ Time Frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h ]
    Fatty acids along with other lipid parameters like triglycerides and cholesterol for normalization purposes will be measured.

  4. insulin resistance [ Time Frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h ]
    Insulin and glucose levels will be measured at each time point, HOMA index will be calculated.

  5. diabetic late complications [ Time Frame: 2 days before supplementation ]
    Patients with confirmed HbA1c > 6,5% will be considered diabetic. Then albumin in urine will be measured and diabetic neuropathy will be assessed clinically via NDS/NSS scoring.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • type 2 diabetes, either dietary treatment or oral medication
  • must be able to give consent

Exclusion Criteria:

  • insulin treated diabetes mellitus
  • severe diseases inducing wasting (e.g. cancer, liver cirrhosis, renal failure)
  • conditions of malnourishment
  • severe anemia
  • pregnancy
  • alcohol abuse

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): NCT02957838


Locations
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Germany
University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69123
Sponsors and Collaborators
University Hospital Heidelberg
German Cancer Research Center
Investigators
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Study Director: Peter P Nawroth, MD University Hospital Heidelberg

Publications:
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Responsible Party: Daniel Pfaff, Principal Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT02957838     History of Changes
Other Study ID Numbers: S-675/2015
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All relevant, collected data will be published.

Keywords provided by Daniel Pfaff, University Hospital Heidelberg:
Transferrin Receptor
Type 2 Diabetes
Stearic Acid (C18:0)
Mitochondrial Morphology
Crossover Study

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases