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

Primary Purpose

Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
High protein diet
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Counties Manukau District Health Board

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Standard Protein Diet

Intervention High Protein Diet

Arm Description

Control Arm Ministry of Health guidelines percentage energy from carbohydrate (50-55%), protein (10-15%) and fat (30%).

Intervention Arm Percentage energy from carbohydrate (40%), protein (30%) and fat (30%).

Outcomes

Primary Outcome Measures

Change in Weight
Scales
Change in Total body muscle mass
Biometric scales

Secondary Outcome Measures

Surgical recovery score
SRS tool
compliance
urinary creatinine

Full Information

First Posted
May 26, 2015
Last Updated
October 26, 2017
Sponsor
University of Auckland, New Zealand
Collaborators
Counties Manukau Health
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1. Study Identification

Unique Protocol Identification Number
NCT02631707
Brief Title
The Effect of High Protein Diets on Weight Loss and Lean Muscle Mass in Patients Awaiting Bariatric Surgery
Official Title
The Effect of High Protein Diets on Weight Loss and Lean Muscle Mass in Patients Awaiting Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand
Collaborators
Counties Manukau Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Standard Protein Diet
Arm Type
No Intervention
Arm Description
Control Arm Ministry of Health guidelines percentage energy from carbohydrate (50-55%), protein (10-15%) and fat (30%).
Arm Title
Intervention High Protein Diet
Arm Type
Experimental
Arm Description
Intervention Arm Percentage energy from carbohydrate (40%), protein (30%) and fat (30%).
Intervention Type
Other
Intervention Name(s)
High protein diet
Intervention Description
The intervention diet is higher in protein than the control diet.
Primary Outcome Measure Information:
Title
Change in Weight
Description
Scales
Time Frame
After 8-weeks of diet and 21-28 days post bariatric surgery
Title
Change in Total body muscle mass
Description
Biometric scales
Time Frame
After 8-weeks of diet and 21-28 days post bariatric surgery
Secondary Outcome Measure Information:
Title
Surgical recovery score
Description
SRS tool
Time Frame
Surgical recovery score 21-28 days post surgery
Title
compliance
Description
urinary creatinine
Time Frame
8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D MacCormick, FRACS
Organizational Affiliation
University of Auckland, New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Counties Manukau District Health Board
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

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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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