Mitochondrial Effects of C18:0 Supplementation in Humans

University Hospital Heidelberg

Status: Completed

Conditions: Type2 Diabetes; Fatty Acid Deficiency; Alteration of Mitochondrial Membrane

Treatments: Dietary Supplement: C18:0; Dietary Supplement: mock

Study type: Interventional

Funder types: Other

Identifiers

NCT02957838

S-675/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Non-diabetics

Experimental group

Description:

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

Treatment:

Dietary Supplement: C18:0

Dietary Supplement: mock

Type 2 Diabetics

Experimental group

Description:

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.

Treatment:

Dietary Supplement: C18:0

Dietary Supplement: mock