utritional repletion before bariatric surgery trial

Not Applicable

Recruiting

• Conditions: Obesity; Micronutrient deficiency; Bariatric-metabolic surgery; Surgery - Other surgery; Diet and Nutrition - Obesity

• Registration Number: ACTRN12623000697684
• Lead Sponsor: Bond University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-30
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Human adults aged 18-65 years.
2.Have elected sleeve gastrectomy as their primary surgery at the recruitment site (a private clinic).
3.Based on a preoperative blood test, has been identified as having at least one of the following micronutrient deficiencies: thiamin, folate, vitamin B12, vitamin D, iron, magnesium, or zinc.
4.BMI 30.0-50.0 kg/m2 2+ weeks prior to surgery.
5.Be willing to accept injection, infusion, and/or oral supplementation as micronutrient repletion strategies.
6.Be willing to stop all non-study related nutritional supplements, herbal preparations, and probiotics from the date of recruitment until Day 1 post-surgery.
7.Be willing to attend three appointments in person at the private clinic: two preoperative and one postoperative appointment. I.e., only local and available participants eligible.
8.2-week intervention phase is feasible based on eligibility confirmation and surgery date.

Exclusion Criteria

1.Medical history of gastrointestinal conditions associated with malabsorption, e.g., coeliac disease, inflammatory bowel disease.
2.Cannot speak, read, or write English.
3.Psychiatric disorder associated with decreased ability to adhere to or tolerate the study conditions, as indicated by the treating psychologist.
4.Patients with known allergy(ies) to vitamin and/or mineral supplementation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified