Mitochondrial Effects of C18:0 Supplementation in Humans

November 23, 2017 updated by: Daniel Pfaff, University Hospital Heidelberg

Mitochondrial Effects of C18:0 Supplementation in Type 2 Diabetics Versus Healthy Controls

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69123
        • University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 days before supplementation, on the day of supplementation at 0, 3 and 6 h
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.
on the day of supplementation at 0, 3 and 6 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 days before supplementation, on the day of supplementation at 0, 3 and 6 h
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.
2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
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.
2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
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.
2 days before supplementation, on the day of supplementation at 0, 3 and 6 h
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.
2 days before supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Heidelberg

Collaborators

German Cancer Research Center

Investigators

  • Study Director: Peter P Nawroth, MD, University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

October 6, 2017

Study Completion (Actual)

November 18, 2017

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 23, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-675/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All relevant, collected data will be published.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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