Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000281998
Ethics application status
Approved
Date submitted
16/02/2020
Date registered
3/03/2020
Date last updated
29/06/2022
Date data sharing statement initially provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Ketogenic Diet In Huntington’s Disease
Scientific title
The Effects of a Ketogenic Diet on the Motor and Cognitive Symptoms of Huntington’s Disease: A Case Series
Secondary ID [1] 300562 0
None
Universal Trial Number (UTN)
U1111-1247-3387
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 316293 0
Condition category
Condition code
Neurological 314564 314564 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 314648 314648 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A modified ketogenic diet. The modified ketogenic plan will be based on recipes containing vegetables, fish, poultry, coconut-based products, avocados, nuts, and natural oils; it will be high in fat (60-65% of energy intake, by weight), moderate in protein (25-30%), and low in carbohydrate (10-15%). There will be space to record daily (bedtime) blood glucose and ketone levels.

The lead investigator and nutrition specialists will show participants how to follow the diet plan. The plan will be adhered to daily for 12 weeks. Participants will do this intervention in their own home.

Regular support and education sessions will be provided:
- Single 40-minute group education session at screening visit discussing content related to concept and potential adverse effects of a keto diet.
- Two 10-minute phone calls during the study regarding content on patient experiences with the keto diet (one in week 1, one in week 7).
- The lead investigator and nutrition specialist will send global e-mails every 2-3 days and we may film and post 10-minute videos on a study website, content answering questions from participants and providing expectations on what to expect with keto diet.
- Single food diary at the start of intervention regarding patient usual diet, adherence will be monitored daily throughout the study using blood glucose and ketone monitor recordings as this is a superior method to ensure ketosis (ie it is a direct measure of ketosis) and food diaries are burdensome for patients.
Intervention code [1] 316867 0
Treatment: Other
Intervention code [2] 316936 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322890 0
Change in Unified Huntington's Disease Rating Scale (UHDRS) motor score from baseline to week 12
Timepoint [1] 322890 0
Baseline to week 12 (12 weeks)
Primary outcome [2] 322891 0
Change in Unified Huntington's Disease Rating Scale (UHDRS) cognitive score from baseline to week 12
Timepoint [2] 322891 0
Baseline to week 12 (12 weeks)
Secondary outcome [1] 380148 0
Change in Unified Huntington's Disease Rating Scale (UHDRS) functional score from baseline to week 12
Timepoint [1] 380148 0
Baseline to week 12 (12 weeks)
Secondary outcome [2] 380149 0
Change in blood glucose levels (mmol/L) from baseline to week 12
Timepoint [2] 380149 0
Baseline to week 12
Secondary outcome [3] 380150 0
Change in blood ketone levels (mmol/L) from baseline to week 12
Timepoint [3] 380150 0
Baseline to week 12
Secondary outcome [4] 380151 0
Change in weight (kg) from baseline to week 12 using a digital weigh scale
Timepoint [4] 380151 0
Baseline to week 12
Secondary outcome [5] 380152 0
Change in body mass index from baseline to week 12 using digital weigh scale and tape measure for height
Timepoint [5] 380152 0
Baseline to week 12
Secondary outcome [6] 380153 0
Change in HbA1C (mmol/mol) from baseline to week 12 on blood serum assay
Timepoint [6] 380153 0
Baseline to week 12
Secondary outcome [7] 380154 0
Change in triglycerides (mmol/L) from baseline to week 12 on blood serum assay
Timepoint [7] 380154 0
Baseline to week 12
Secondary outcome [8] 380155 0
Change in high-density lipoprotein cholesterol (mmol/L) from baseline to 12 weeks on blood serum assay
Timepoint [8] 380155 0
Baseline to 12 weeks
Secondary outcome [9] 380156 0
Change in low-density lipoprotein cholesterol (mmol/L) from baseline to 12 weeks on blood serum assay
Timepoint [9] 380156 0
Baseline to 12 weeks
Secondary outcome [10] 380157 0
Change in total cholesterol (mmol/L) from baseline to 12 weeks on blood serum assay
Timepoint [10] 380157 0
Baseline to 12 weeks

Eligibility
Key inclusion criteria
(1) Aged 20 to 80 years.
(2) Huntington’s confirmed by genetic diagnosis with 40 or more CAG repeats and definite motor manifestation as determined by a neurologist.
(3) Sufficient consent capacity (passing grade on the modified dementia Informed Consent questionnaire, defined as at least 70% of questions 1 to 10 correct and 100% of questions 11 to 14 correct on the first or second administration).
(4) BMI >18.5.
(5) A cohabiting study partner able and willing to follow the diet plan.

Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Inability to speak or understand English.
(2) A concurrent medical or psychiatric condition that in the opinion of the investigators would make it difficult to complete the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Due to lockdown restrctions, the trial did not proceed.
Date of first participant enrolment
Anticipated
1/07/2020
Actual
Date of last participant enrolment
Anticipated
1/08/2020
Actual
Date of last data collection
Anticipated
1/11/2020
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 22357 0
New Zealand
State/province [1] 22357 0
Waikato, Bay of Plenty, Auckland

Funding & Sponsors
Funding source category [1] 304981 0
Hospital
Name [1] 304981 0
Neurology Dept Research Fund
Country [1] 304981 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato Hospital
Address
Pembroke St, Hamilton 3204 NZ
Country
New Zealand
Secondary sponsor category [1] 305342 0
None
Name [1] 305342 0
Address [1] 305342 0
Country [1] 305342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305384 0
Health and Disability Ethics Committee
Ethics committee address [1] 305384 0
Ethics committee country [1] 305384 0
New Zealand
Date submitted for ethics approval [1] 305384 0
01/02/2020
Approval date [1] 305384 0
04/03/2020
Ethics approval number [1] 305384 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100194 0
Dr Matthew CL Phillips
Address 100194 0
Neurology Dept, Level 1 Reception A, Waikato Hospital Pembroke St 3204 Hamilton NZ
Country 100194 0
New Zealand
Phone 100194 0
+64 0274057415
Fax 100194 0
Email 100194 0
Matthew.Phillips@waikatodhb.health.nz
Contact person for public queries
Name 100195 0
Matthew CL Phillips
Address 100195 0
Neurology Dept, Level 1 Reception A, Waikato Hospital Pembroke St 3204 Hamilton NZ
Country 100195 0
New Zealand
Phone 100195 0
+64 0274057415
Fax 100195 0
Email 100195 0
Matthew.Phillips@waikatodhb.health.nz
Contact person for scientific queries
Name 100196 0
Matthew CL Phillips
Address 100196 0
Neurology Dept, Level 1 Reception A, Waikato Hospital Pembroke St 3204 Hamilton NZ
Country 100196 0
New Zealand
Phone 100196 0
+64 0274057415
Fax 100196 0
Email 100196 0
Matthew.Phillips@waikatodhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient details will be kept confidential.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.