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A pseudo-randomised dietary intervention to evaluate the effects of a high protein diet on weight loss, body composition and other health outcomes in obese individuals who have gastric banding surgery.

A pseudo-randomised dietary intervention to evaluate the effects of a high protein diet on weight loss, body composition and other health outcomes in obese individuals who have gastric banding surgery.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000258257
Enrollment
47
Registered
2009-05-13
Start date
2009-03-17
Completion date
2009-11-27
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to investigate the usefulness of a high protein diet for obese individuals who have undergone gastric banding. It is a pseudo-randomised control trial comparing a high protein diet with usual dietetic care after surgery. The intervention period will be of six months duration with a further six months of follow-up. This study will help to inform best practice nutritional management for individuals who have had gastric banding.

Interventions

The intervention involves a high protein diet for 26 weeks (6 months) following surgery. The intervention diet has been designed to provide approximately: 4500-5000kJ, 90-100g protein, 110g carbohydrate and 30g fat per day. This provides a macronutrient composition of approximately 35% protein, 40% carbohydrate and 25% fat. Participants will commence the intervention within 3 weeks of having surgery and according to clinical assessment. The intervention includes high protein food and drink choic

The intervention involves a high protein diet for 26 weeks (6 months) following surgery. The intervention diet has been designed to provide approximately: 4500-5000kJ, 90-100g protein, 110g carbohydrate and 30g fat per day. This provides a macronutrient composition of approximately 35% protein, 40% carbohydrate and 25% fat. Participants will commence the intervention within 3 weeks of having surgery and according to clinical assessment. The intervention includes high protein food and drink choices and a powder-based whey protein supplement. Participants will be asked to have 3 level tablespoons of the supplement daily, providing approximately 12g of protein per day. The supplement can be mixed with regular foods and drinks and either consumed as a dispersed dose (eg one tablespoon three times per day) or as one 3 tablespoon dose, determined at the convenience of the participant. Participants will also continue to receive usual dietetic care in addition to the research intervention. Usual dietetic care consists of regular follow-up with a gastric banding dietitian, who provides individualised advice on food, nutrition and activity as appropriate for gastric banding. This will be administered via face-to-face and telephone consultations (of approximately 30 minutes duration) which will occur approximately every 2-6 weeks after surgery. Specific frequency and duration of consultations is determined by the gastric banding dietitian according to individual need.

Sponsors

University of Newcastle
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

- Undergoing or have undergone gastric banding no later than two weeks prior to study entry. - Body Mass Index (BMI) > 30 kg/m2. - Can understand, read and write English. - Has provided written, informed consent. - Surgeon has approved participation in the study

Exclusion criteria

Chronic conditions requiring a specialised diet; food allergy or intolerance that may affect health or compliance with the study; vegetarian; individuals who cannot understand or follow the study diet; surgeon does not approve participation in the study; women who are pregnant or lactating; unwilling to be randomised to either diet group; pacemaker or other electronic implant.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026