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Trial record 55 of 69 for:    ORLISTAT

Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study (MIX-UP)

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ClinicalTrials.gov Identifier: NCT03736551
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Obesity Behavioral: 5:2 diet Behavioral: Renal Weight Management Programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel arm, single blinded, randomised controlled feasibility study
Masking: Single (Outcomes Assessor)
Masking Description: Study outcome measures performed by assessor blinded to treatment arm
Primary Purpose: Treatment
Official Title: Model of Intermittent Very Low Energy Diet and eXercise for Lowering BMI in Patients With CKD (MIX UP): Feasibility Study
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Intervention
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.
Behavioral: 5:2 diet
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)

Behavioral: Renal Weight Management Programme
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.

Active Comparator: Standard Care
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.
Behavioral: Renal Weight Management Programme
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Recruitment rate of at least 50% of potential participants meeting inclusion and exclusion criteria [ Time Frame: 1 year ]
    at least 50% of those meeting the referral criteria and are approached to participant, consent to participating in the study

  2. Compliance with dietary intervention from dietary records [ Time Frame: 6 months ]
    at least 70% compliance with prescribed diet

  3. Weight change (kg) [ Time Frame: 6 months ]
    change in weight from baseline to 6 months

  4. kidney function (eGFR ml/min CKD EPI equation) [ Time Frame: 6 months ]
    monitoring if estimated kidney function declines during the study or if symptomatic for dehydration.

  5. Waist circumference (cm) [ Time Frame: 6 months ]
    change in waist circumference measured in cm at level of umbilicus

  6. Body composition [ Time Frame: 6 months ]
    lean and fat mass (kg) estimated by bioelectrical impedance analysis

  7. Exercise capacity - 6 minute timed walk test [ Time Frame: 6 months ]
    distance walked (m) in 6 minutes

  8. Exercise capacity - sit to stand 60 [ Time Frame: 6 months ]
    number (count) of sit to stand movements in 60 seconds

  9. Proteinuria [ Time Frame: 6 months ]
    urinary protein to creatinine ratio

  10. Total Cholesterol [ Time Frame: 6 months ]
    plasma total cholesterol concentration

  11. Triglycerides [ Time Frame: 6 months ]
    plasma triglycerides concentration

  12. LDL cholesterol [ Time Frame: 6 months ]
    plasma LDL cholesterol concentration

  13. HDL cholesterol [ Time Frame: 6 months ]
    plasma HDL cholesterol concentration



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18-75 years
  • KDIGO defined CKD (all categories)
  • BMI ≥30kg/m2
  • able to provide written informed consent in English

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736551


Contacts
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Contact: Helen L MacLaughlin, PhD +44 20 32996250 helen.maclaughlin@nhs.net
Contact: The Research Office +44 20 3299 9000 ext 31980 kch-tr.research@nhs.net

Locations
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United Kingdom
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: The Research Office    +4420 3299 9000 ext 31980      
Principal Investigator: Helen L MacLaughlin, BSc (Hons)         
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
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Principal Investigator: Helen L MacLaughlin, PhD King's College Hospital NHS Fundation Trust

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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT03736551     History of Changes
Other Study ID Numbers: KCH17-027
202350 ( Registry Identifier: IRAS )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College Hospital NHS Trust:
intermittent fasting
weight loss
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency