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

NCT ID: NCT02631707

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Standard Protein Diet

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention High Protein Diet

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

Group Type EXPERIMENTAL

High protein diet

Intervention Type OTHER

The intervention diet is higher in protein than the control diet.

Interventions

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High protein diet

The intervention diet is higher in protein than the control diet.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Counties Manukau Health

OTHER

Sponsor Role collaborator

University of Auckland, New Zealand

OTHER

Sponsor Role lead

Responsible Party

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Andrew MacCormick

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew D MacCormick, FRACS

Role: PRINCIPAL_INVESTIGATOR

University of Auckland, New Zealand

Locations

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Counties Manukau District Health Board

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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Highproteinbariatric

Identifier Type: -

Identifier Source: org_study_id