Clinical Trials Directory

Trials / Completed

CompletedNCT02957838

Mitochondrial Effects of C18:0 Supplementation in Humans

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
University Hospital Heidelberg · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTC18:0Receives 24g of C18:0 in a low-fat banana milkshake.
DIETARY_SUPPLEMENTmockLow fat banana milkshake without C18:0 supplement.

Timeline

Start date
2016-11-01
Primary completion
2017-10-06
Completion
2017-11-18
First posted
2016-11-08
Last updated
2017-11-27

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02957838. Inclusion in this directory is not an endorsement.