Mitochondrial Effects of C18:0 Supplementation in Humans
- Conditions
- Alteration of Mitochondrial MembraneType2 DiabetesFatty Acid Deficiency
- Interventions
- Dietary Supplement: mock
- Registration Number
- NCT02957838
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- type 2 diabetes, either dietary treatment or oral medication
- must be able to give consent
- insulin treated diabetes mellitus
- severe diseases inducing wasting (e.g. cancer, liver cirrhosis, renal failure)
- conditions of malnourishment
- severe anemia
- pregnancy
- alcohol abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Non-diabetics mock Non-diabetic volunteers with HbA1c \< 6.5%. Subjects will be treated with C18:0 supplementation or mock. Type 2 Diabetics mock 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.
- Primary Outcome Measures
Name Time Method Changes in Mitochondrial Morphology 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.
Changes in Mitochondrial Function 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
Name Time Method plasma iron, transferrin, ferritin, ferroportin and hepcidin levels 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.
plasma methylglyoxal levels 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.
plasma fatty acid levels 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.
insulin resistance 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.
diabetic late complications 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.
Trial Locations
- Locations (1)
University of Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany