Low Residue Diet Study in Mitochondrial Disease

Summary

Slow movement of patients guts is referred to as intestinal dysmotility, and is increasingly recognised as a debilitating manifestation of mitochondrial disease both in adults and children.

To date, symptoms of slow gut movements have been managed with laxatives and drugs that increase movement of the guts with variable results. A low residue diet is a form of low fibre diet (\<10g fibre per day) that is used to minimise symptoms of poor movement of the guts. This reduces fecal volume and bulk, and hence gut workload, ensuring limited bowel activity and colonic rest. It has been shown to be well accepted in other conditions associated with slow gut movements. However, its role in patients with mitochondrial disease is unknown. The investigators are particularly interested in:

* Does a low residue diet (low fibre) cause a change in the number of stools per week and stool consistency?
* Is a low residue diet tolerated well and easy to comply with?
* Does a low residue diet reduce gut symptoms of abdominal pain, bloating, and constipation?
* Does a low residue diet improve quality of life and disease burden?
* Does a low residue diet affect the bacteria in the gut?
* Can we prove by X-ray that movement of food through the gut is slowed in patients with mitochondrial disease, and whether a low residue diet alters the speed of movement of food through the gut?
* Can a low residue diet change patients physical activity levels?
* Does a low reside diet change dietary patterns and food intake?
* Does a low residue diet alter anthropometrics, such as weight, body mass index and waist to hit ratio?
* Can a low residue diet improve kidney and liver function and lipid profile in blood samples?

The investigators hope that by looking at these areas that a low residue diet may be able to improve patients slow gut movements, health, quality of life and disease burden.

Conditions

• Mitochondrial Diseases

Interventions

DIETARY_SUPPLEMENT

Low Residue Diet Intervention

All patients will be provided with a LRD plan (\< 10g fibre per day) for 12 weeks between visits 2 and 3. They will also be supplemented with multivitamin and mineral tablet or liquid (Forceval) to meet nutrient requirements (prescribed as standard care). The dietitian will provide written and oral information about the LRD and weekly telephone calls to assess patient's progress on the diet.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• Newcastle University

  lead OTHER

Principal Investigators

• Grainne S Gorman, MD · Newcastle University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-08

Primary Completion

2019-02-07

Completion

2019-02-07

Countries

• United Kingdom

Study Locations