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MItochondrial Diabetes LOw Carb- Diet Study

NCT06185790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-01-13

No results posted yet for this study

Summary

In daily practice, doctors and dietitians in the clinic receive many questions in general from patients with a Mitochondrial Disease (MD), and more specific whether nutritional changes can alleviate their symptoms. Mitochondrial Inherited Diabetes and Deafness (MIDD) is due to a mitochondrial mutation at the m.3243A\>G locus. Nutrition is known to affect disease burden in MIDD. Which diet does this best is unknown. Very low carbohydrate high fat diets improve mitochondrial function in isolated cells and in mice. Whether it does so in people with MIDD is unknown. Therefore, the objective of the study is to explore the effect of a low carbohydrate- high fat diet (LCHF) on clinical symptoms (Goal Attainment Scaling) and gut microbiome in patients with MIDD due to the m.3243A\>G mutation. A total of 20 adult patients with the above mentioned characteristics will be randomized to receive first usual care during three months (control period), followed by LCHF dietary intervention for the next three months (intervention period), or vice versa.

Conditions

  • Mitochondrial Diseases
  • Diabetes-Deafness Syndrome Maternally Transmitted

Interventions

OTHER

LCHF diet

Low-carb high-fat (LCHF) diet

Sponsors & Collaborators

  • Stichting Stofwisselkracht

    collaborator UNKNOWN

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Heidi Zweers- van Essen, Doctor · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2025-01-03
Completion
2025-01-03

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06185790 on ClinicalTrials.gov