The effect of a low carbohydrate- high fat diet on clinical symptoms and gut microbiome in m.3243A>G related mitochondrial disease

The effect of a low carbohydrate- high fat diet on clinical symptoms and gut microbiome in m.3243A>G related mitochondrial disease - MIDLOC diet study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53235

Enrollment

Registered

2023-11-29

Start date

2024-01-05

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mitochondrial disease

Interventions

Low carbohydrate (50-100 grams/day). The LCHF restricts a wide range of carbohydrate rich foods including sweets, sugar, grains, starchy vegetables, sweet legumes, fruit juices and sweetened dairy

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • m.3243A>G mutation • good cognitive function • BMI >=18,5 kg/m2

Exclusion criteria

Exclusion criteria: • Kidney failure: MDRD

Design outcomes

Primary

Measure	Time frame
GAS (Goal Attainment scaling) Stool samples for faecal microbiome composition analyses.	—

Secondary

Measure	Time frame
• Glucosemetrics (only in diabetes patients ± 50% of the population) : HbA1C, home glucose monitoring (time in range hypoglycemia, hyperglycemia), diabetes medication and doses (insulin use). • Gastrointestinal complaints: Questionnaire including a VAS score on severity of gastrointestinal complaints, stool frequency, Bristol stool chart and laxative use. • Diet adherence (digital food diary 3 days including one weekend day) • CIS fatigue questionnaire • Newcastle Mitochondrial Disease Adult Scale (NMDAS) (on disease severity) including SF-12 (quality of life questionnaire) • Physical Activity measurement using Accelerometry (activ8®) • Headache diary • Nutritional assessment: Weight, Height, BMI, body composition (Fat free mass and Fat percentage) • Laboratory examinations (CK, HbA1c, lipid profile, kidney function, transaminases, lactate, ketone bodies, metabolomics) and home glucose monitoring	—

Measure

Time frame

• Glucosemetrics (only in diabetes patients ± 50% of the population) : HbA1C, home glucose monitoring (time in range hypoglycemia, hyperglycemia), diabetes medication and doses (insulin use). • Gastrointestinal complaints: Questionnaire including a VAS score on severity of gastrointestinal complaints, stool frequency, Bristol stool chart and laxative use. • Diet adherence (digital food diary 3 days including one weekend day) • CIS fatigue questionnaire • Newcastle Mitochondrial Disease Adult Scale (NMDAS) (on disease severity) including SF-12 (quality of life questionnaire) • Physical Activity measurement using Accelerometry (activ8®) • Headache diary • Nutritional assessment: Weight, Height, BMI, body composition (Fat free mass and Fat percentage) • Laboratory examinations (CK, HbA1c, lipid profile, kidney function, transaminases, lactate, ketone bodies, metabolomics) and home glucose monitoring

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)