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

NCT02631707 | Completed DMC

• 1 other identifier: Highproteinbariatric
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Outcome Measures

Primary Outcomes (2)

• Change in Weight

  Scales

  After 8-weeks of diet and 21-28 days post bariatric surgery

• Change in Total body muscle mass

  Biometric scales

  After 8-weeks of diet and 21-28 days post bariatric surgery

Secondary Outcomes (2)

• Surgical recovery score

  Surgical recovery score 21-28 days post surgery

• compliance

  8 weeks

Study Arms (2)

Control Standard Protein Diet

NO INTERVENTION

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

Intervention High Protein Diet

EXPERIMENTAL

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

Other: High protein diet

Interventions

High protein diet OTHER

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

Intervention High Protein Diet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Auckland, New Zealand: lead
• Counties Manukau Health: collaborator

Study Sites (1)

Counties Manukau District Health Board

Auckland, New Zealand

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Andrew D MacCormick, FRACS

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: December 16, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

NZ (1)