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The Effect of High Protein Diets on Weight Loss and Lean Muscle Mass in Patients Awaiting Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02631707
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Counties Manukau Health
Information provided by (Responsible Party):
Andrew MacCormick, University of Auckland, New Zealand

Brief Summary:
All patients in CMDHB eligible for bariatric surgery are given a weight loss goal prior to surgery. It is unknown what the most effective diet is to lose weight, while still preserving muscle mass. The diet must also be acceptable and adhered to by patients. The aim of this study is to find out if a diet that is higher in protein and lower in carbohydrate than the standard Ministry of Health guidelines will have a greater effect on weight loss, preservation of lean muscle mass, surgical recovery score, adherence and acceptability.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Other: High protein diet Not Applicable

Detailed Description:
This pilot project is a randomised control trial with 24 participants. Diets will consist of 1200 and 1500kcals for females and males, respectively. The control arm is to receive the Ministry of Health guidelines percentage energy from carbohydrate (50-55%), protein (10-15%) and fat (30%). The intervention arm is to be lower in carbohydrate (40%), higher in protein (30%), moderate fat (30%). Participants will be required to continue the diet for at least 8 weeks while waiting for surgery. At baseline and at eight weeks their weight, hip circumference, waist circumference, neck circumference and body composition measurements will be taken. During their prescribed diet they are required to fill out a 3-day diet record. At the end of eight weeks the participants will perform a twenty-four hour urine collect for urea and creatinine. This will help determine adherence. Post-surgery (21-28 days) they will be required to complete a surgical recovery questionnaire and the above measurements will be recorded again. These data will be collected over a period beginning January 2015. It is expected that the intervention arm will have greater weight loss and better preservation of muscle mass leading to a better surgical recovery score. However because the intervention requires a higher intake of protein this may have an effect on adherence and acceptability in these participants. There are no known adverse effects of the intervention diet in the short term.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of High Protein Diets on Weight Loss and Lean Muscle Mass in Patients Awaiting Bariatric Surgery
Study Start Date : May 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Standard Protein Diet
Control Arm Ministry of Health guidelines percentage energy from carbohydrate (50-55%), protein (10-15%) and fat (30%).
Experimental: Intervention High Protein Diet
Intervention Arm Percentage energy from carbohydrate (40%), protein (30%) and fat (30%).
Other: High protein diet
The intervention diet is higher in protein than the control diet.




Primary Outcome Measures :
  1. Change in Weight [ Time Frame: After 8-weeks of diet and 21-28 days post bariatric surgery ]
    Scales

  2. Change in Total body muscle mass [ Time Frame: After 8-weeks of diet and 21-28 days post bariatric surgery ]
    Biometric scales


Secondary Outcome Measures :
  1. Surgical recovery score [ Time Frame: Surgical recovery score 21-28 days post surgery ]
    SRS tool

  2. compliance [ Time Frame: 8 weeks ]
    urinary creatinine



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants in this study will be patients eligible for bariatric surgery under CMDHB. These participants must have a BMI greater than 35kg/m2 with co-morbidities or a BMI greater than 40kg/m2.

Exclusion Criteria:

  • Patients will be excluded from study if they do not attend surgeon or dietitian appointments. To be included in this study patients must be English speaking and weigh under 200kg.

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): NCT02631707


Locations
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New Zealand
Counties Manukau District Health Board
Auckland, New Zealand
Sponsors and Collaborators
University of Auckland, New Zealand
Counties Manukau Health
Investigators
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Principal Investigator: Andrew D MacCormick, FRACS University of Auckland, New Zealand

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Responsible Party: Andrew MacCormick, Investigator, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT02631707     History of Changes
Other Study ID Numbers: Highproteinbariatric
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Obesity, Morbid
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight