Mitochondrial Effects of C18:0 Supplementation in Humans

NCT ID: NCT02957838

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-11-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alteration of Mitochondrial Membrane Type2 Diabetes Fatty Acid Deficiency

Keywords

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Transferrin Receptor Type 2 Diabetes Stearic Acid (C18:0) Mitochondrial Morphology Crossover Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Non-diabetics

Non-diabetic volunteers with HbA1c \< 6.5%. Subjects will be treated with C18:0 supplementation or mock.

Group Type EXPERIMENTAL

C18:0

Intervention Type DIETARY_SUPPLEMENT

Receives 24g of C18:0 in a low-fat banana milkshake.

mock

Intervention Type DIETARY_SUPPLEMENT

Low fat banana milkshake without C18:0 supplement.

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.

Group Type EXPERIMENTAL

C18:0

Intervention Type DIETARY_SUPPLEMENT

Receives 24g of C18:0 in a low-fat banana milkshake.

mock

Intervention Type DIETARY_SUPPLEMENT

Low fat banana milkshake without C18:0 supplement.

Interventions

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C18:0

Receives 24g of C18:0 in a low-fat banana milkshake.

Intervention Type DIETARY_SUPPLEMENT

mock

Low fat banana milkshake without C18:0 supplement.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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stearic acid stearic acid, Sigma-Aldrich, product number W303518

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Cancer Research Center

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Daniel Pfaff

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter P Nawroth, MD

Role: STUDY_DIRECTOR

University Hospital Heidelberg

Locations

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University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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Senyilmaz D, Virtue S, Xu X, Tan CY, Griffin JL, Miller AK, Vidal-Puig A, Teleman AA. Regulation of mitochondrial morphology and function by stearoylation of TFR1. Nature. 2015 Sep 3;525(7567):124-8. doi: 10.1038/nature14601. Epub 2015 Jul 27.

Reference Type BACKGROUND
PMID: 26214738 (View on PubMed)

Other Identifiers

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S-675/2015

Identifier Type: -

Identifier Source: org_study_id