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OpenTrials
Completed

NCT Number: NCT02631707

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Counties Manukau District Health Board

Auckland, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High protein diet

Other

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

Primary outcomes

  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 outcomes

  1. Surgical recovery score

    Time frame: Surgical recovery score 21-28 days post surgery

    SRS tool

  2. compliance

    Time frame: 8 weeks

    urinary creatinine

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • Counties Manukau Health

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2015
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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