Chronic Kidney DiseasesMIX-UPNCT03736551
Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study
A study testing 5:2 diet and Renal Weight Management Programme in people with Chronic Kidney Diseases and Obesity, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2 diet) plus exercise, compared with the investigator's established Weight Management Programme (WMP), in obese patients with CKD, using feasibility study methodology. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases, Obesity
- What is being tested?
- 5:2 diet and Renal Weight Management Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2017to 6 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-75 years
- KDIGO defined CKD (all categories)
- BMI ≥30kg/m2
- able to provide written informed consent in English
Who cannot join
- pregnant or breastfeeding women
- conservatively managed CKD stage 5
- palliative or active treatment for cancer
- unstable chronic liver disease
- type 1 diabetes and type 2 diabetes controlled with anti-hyperglycaemic medication
- previous bariatric surgery
Show all 11Show fewer
- unable to provide written informed consent
- significant psychiatric disorder or uncontrolled depression
- participated in a weight management drug trial in the previous 3 months
- uncontrolled epilepsy
- alcohol or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Model of Intermittent Very Low Energy Diet and eXercise for Lowering BMI in Patients With CKD (MIX UP): Feasibility Study
This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2 diet) plus exercise, compared with the investigator's established Weight Management Programme (WMP), in obese patients with CKD, using feasibility study methodology.
Patients will be invited to participate in the parallel arm, single blinded, randomised controlled feasibility study, and randomly allocated to 1 of 2 treatments for 6 months. The experimental arm involves an intermittent modified fasting regimen consisting of VLED (600 kcal/day) on 2 consecutive days, and 5 days each week on a modified diet to maintain an overall energy deficit of 600 kcal/day across the week (5:2 diet). The control arm will be the standard renal WMP with a continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day.
The feasibility outcomes are: recruitment rate >50%; intervention retention rate at 6 months >60%; dietary intervention compliance; and weight loss. Secondary outcomes include safety, body composition, proteinuria, lipids, blood pressure, and eating desire. Measurements will be made at baseline, midpoint, and twice at endpoint.
- Conditions
- Chronic Kidney Diseases, Obesity
- Being tested
- 5:2 diet, Renal Weight Management Programme
- Keywords
- intermittent fasting, weight loss
- Medical subject headings
- Renal Insufficiency, Chronic, Obesity, Intermittent Fasting, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5:2 dietBehavioural
very low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet)
Renal Weight Management ProgrammeBehavioural
Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure. In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will involve standard care plus an intermittent modified fasting regimen consisting of a very low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet). All dietary intake on modified fasting days will be from LighterLife foodpacks, (4 x 150 kcal portions/day presented as milkshakes, cereal bars, soups and modified meals such as spaghetti bolognese, or macaroni cheese) providing ~600 kcal/day and 100% of the RNI for vitamins and minerals. Receives: Behavioral: 5:2 diet; Behavioral: Renal Weight Management Programme |
| Standard Care | Active comparator | Renal Weight management Programme - Patients will attend individual appointments with the specialist dietitian and physiotherapist once a month, for 6 months. Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure (9). In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing. Receives: Behavioral: Renal Weight Management Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate of at least 60% in the intervention group
Patients attending at least 80% of monthly clinic visits, including the baseline and final study visits, and remaining compliant with the 2 consecutive days VLED throughout the 6 month intervention will be considered "completers" and count as being retained in the intervention group at 6 months.
Measured: 6 months
Number of Adverse Events following intermittent very low energy diet
record of all adverse events including but not limited to nausea, constipation and/or diarrhoea, dehydration, hypoglycaemia, lethargy \& fatigue, headaches, gallstones and gout.
Measured: 6 months
Secondary outcomes (13)
Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria
at least 50% of those meeting the referral criteria and are approached to participant, consent to participating in the study
Measured: 1 year
Compliance with dietary intervention from dietary records
at least 70% compliance with prescribed diet
Measured: 6 months
Weight change (kg)
change in weight from baseline to 6 months
Measured: 6 months
kidney function (eGFR ml/min CKD EPI equation)
monitoring if estimated kidney function declines during the study or if symptomatic for dehydration.
Measured: 6 months
Waist circumference (cm)
change in waist circumference measured in cm at level of umbilicus
Measured: 6 months
Body composition
lean and fat mass (kg) estimated by bioelectrical impedance analysis
Measured: 6 months
Exercise capacity - 6 minute timed walk test
distance walked (m) in 6 minutes
Measured: 6 months
Exercise capacity - sit to stand 60
number (count) of sit to stand movements in 60 seconds
Measured: 6 months
Proteinuria
urinary protein to creatinine ratio
Measured: 6 months
Total Cholesterol
plasma total cholesterol concentration
Measured: 6 months
Triglycerides
plasma triglycerides concentration
Measured: 6 months
LDL cholesterol
plasma LDL cholesterol concentration
Measured: 6 months
HDL cholesterol
plasma HDL cholesterol concentration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start25 Oct 2017
- Primary completion31 Dec 2018
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel arm, single blinded, randomised controlled feasibility study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen L MacLaughlin, PhD, Principal investigator, King's College Hospital NHS Fundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736551
- Sponsor's protocol ID
- KCH17-027
- Other IDs
- 202350
- Acronym
- MIX-UP
- Status last verified
- Jul 2018
- First submitted
- 1 Aug 2018
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model of Intermittent Very Low Energy Diet and eXercise for Lowering BMI in Patients With CKD (MIX UP): Feasibility Study
- ClinicalTrials.gov ID
- NCT03736551
- Acronym / sponsor ID
- MIX-UP / KCH17-027
- Conditions
- Chronic Kidney Diseases, Obesity
- Keywords
- intermittent fasting, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2 diet) plus exercise, compared with the investigator's established Weight Management Programme (WMP), in obese patients with CKD, using feasibility study methodology.
Patients will be invited to participate in the parallel arm, single blinded, randomised controlled feasibility study, and randomly allocated to 1 of 2 treatments for 6 months. The experimental arm involves an intermittent modified fasting regimen consisting of VLED (600 kcal/day) on 2 consecutive days, and 5 days each week on a modified diet to maintain an overall energy deficit of 600 kcal/day across the week (5:2 diet). The control arm will be the standard renal WMP with a continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day.
The feasibility outcomes are: recruitment rate >50%; intervention retention rate at 6 months >60%; dietary intervention compliance; and weight loss. Secondary outcomes include safety, body composition, proteinuria, lipids, blood pressure, and eating desire. Measurements will be made at baseline, midpoint, and twice at endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel arm, single blinded, randomised controlled feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: 5:2 diet, Behavioral: Renal Weight Management ProgrammeThe intervention arm will involve standard care plus an intermittent modified fasting regimen consisting of a very low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet). All dietary intake on modified fasting days will be from LighterLife foodpacks, (4 x 150 kcal portions/day presented as milkshakes, cereal bars, soups and modified meals such as spaghetti bolognese, or macaroni cheese) providing ~600 kcal/day and 100% of the RNI for vitamins and minerals. |
| Standard Care | Active comparator | Behavioral: Renal Weight Management ProgrammeRenal Weight management Programme - Patients will attend individual appointments with the specialist dietitian and physiotherapist once a month, for 6 months. Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure (9). In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18-75 years
- KDIGO defined CKD (all categories)
- BMI ≥30kg/m2
- able to provide written informed consent in English
Key exclusion criteria (11 listed)
- pregnant or breastfeeding women
- conservatively managed CKD stage 5
- palliative or active treatment for cancer
- unstable chronic liver disease
- type 1 diabetes and type 2 diabetes controlled with anti-hyperglycaemic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5:2 dietvery low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet) | Behavioural | Intervention |
| Renal Weight Management ProgrammeDietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure. In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing. | Behavioural | Intervention, Standard Care |
Primary outcome
Retention rate of at least 60% in the intervention group
Time frame: 6 months
Patients attending at least 80% of monthly clinic visits, including the baseline and final study visits, and remaining compliant with the 2 consecutive days VLED throughout the 6 month intervention will be considered "completers" and count as being retained in the intervention group at 6 months.
Number of Adverse Events following intermittent very low energy diet
Time frame: 6 months
record of all adverse events including but not limited to nausea, constipation and/or diarrhoea, dehydration, hypoglycaemia, lethargy \& fatigue, headaches, gallstones and gout.
13 secondary outcomes
Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria
Time frame: 1 year
Compliance with dietary intervention from dietary records
Time frame: 6 months
Weight change (kg)
Time frame: 6 months
kidney function (eGFR ml/min CKD EPI equation)
Time frame: 6 months
Waist circumference (cm)
Time frame: 6 months
Body composition
Time frame: 6 months
Exercise capacity - 6 minute timed walk test
Time frame: 6 months
Exercise capacity - sit to stand 60
Time frame: 6 months
Proteinuria
Time frame: 6 months
Total Cholesterol
Time frame: 6 months
Triglycerides
Time frame: 6 months
LDL cholesterol
Time frame: 6 months
HDL cholesterol
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen L MacLaughlin, PhD principal investigator
King's College Hospital NHS Fundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5:2 diet and Renal Weight Management Programme in people with Chronic Kidney Diseases and Obesity, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate of at least 60% in the intervention group (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.