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Objectives This randomized controlled trial aimed to assess whether structured dietary interventions, implemented both before and after orthognathic surgery, could minimize postoperative weight loss and thereby enhance recovery during the first eight weeks.
Material and Methods The study was conducted at Aalborg University Hospital, Denmark, from April 2017 to April 2022, involving patients undergoing single- or bimaxillary surgery. Participants were randomly allocated into two intervention groups receiving nutritional supplements and one control group. Body composition was assessed using a Body Composition Analyzer at five time points: pre-surgery examination, admission, and follow-ups weeks 1, 3, and 8. Primary outcome was weight, secondary outcomes included BMI, fat mass, fat-free mass, total body water, and visceral fat rating. Additional data were collected on age, gender, type of surgery, and hospitalization duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controle | No Intervention | Usual care | |
| G-tube administered Nutrition and Protein drinks | Experimental | Nutrition supplement: G-tube administered Nutrition and Protein drinks |
|
| Protein drink | Experimental | Nutrition supplement: Protein drink |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group receiving nutritional supplements through G-tube and Protein drinks | Other | Nutrition supplement: G-tube administered Nutrition and Protein drinks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in weight in kilogram after orthognatic surgery | Weight changes was the primary measure of interest, assessed using the Tanita BC-418 Segmental Body Composition Analyzer. Measurements were taken during scheduled hospital appointments; the pre-surgery examination, admission interview, and follow-up visits at week 1-, 3- and 8. | From enrollment, (14 days before surgery), to 8 weeks after surgery. |
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Inclusion Criteria:
Exclusion Criteria: Patients not willing to complete the planned treatment in the intervention groups.
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| Name | Affiliation | Role |
|---|---|---|
| Karin Bundgaard, PhD | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark |
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| Intervention group receiving nutritional supplements through Protein drinks | Other | Nutrition supplements recieved through intake of Protein drinks |
|