Efficacy of Liquid Versus Powder Protein Supplementation to Optimize Protein Intake After Bariatric Surgery

NCT06267677 | Completed

• 1 other identifier: 2007/3928
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. The main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications. Participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made:

• Analytical determination
• Nitrogen balance by determining urea N2 in 24-hour urine
• Anthropometric determinations
• Body composition determined by impedanciometry
• Resting energy expenditure and nutrient oxidation measured by indirect calorimetry.
• Energy, protein and hydration intake.
• Gastrointestinal tolerance through self-registration of symptoms. Researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery.

Conditions

Body Composition; Obesity; Protein Supplementation; Bariatric Surgery Candidate; Weight Loss

Outcome Measures

Primary Outcomes (3)

• protein intake

  Achieving the protein intake goal established for patients after obesity surgery.

  2 months

• evaluate nutritional deficiencies

  Nutritional status and the preservation of lean mass during the rapid phase of weight loss

  2 months

• Tolerance

  Gastrointestinal tolerance during the first two months after surgery.

  2 months

Study Arms (2)

High protein liquid formula

EXPERIMENTAL

Patients allocated in the intervention group (n=15) received 4 high-protein shakes and the corresponding standard vitamin-mineral (VM) supplementation according to our post BS protocol, then progressed towards a diet that combines traditional foods with 2 hLF shakes per day and VM supplementation for 15 days. Over the following 15 days, patients continued to normalize their diet, including a single hLF shake per day and continued with VM supplementation.

Dietary Supplement: High protein liquid formula

Standard care diet

NO INTERVENTION

Patients in the control group (n=35) followed the traditional protocol after bariatric surgery (sCD-group) consisting of a progressive diet with traditional foods, recommendation of 23g/d of protein powder and standard vitamin-mineral supplementation during the first 2 weeks after the surgery. From then on and according to current dietary protocols, the recommendation for protein powder decreases from 23g to 15g up to the end of the study.

Interventions

High protein liquid formula DIETARY_SUPPLEMENT

liquid and high amount of protein

High protein liquid formula

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes between 18 and 65 years of age undergoing bariatric surgery in our center With the ability to understand the objectives and proposals of the study That they agree to participate in the study.

You may not qualify if:

• Patients who have had perioperative complications and who require an extended hospital stay Patients who after the intervention require some type of artificial nutritional support Patients who have undergone a surgical technique other than BPG.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

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: PhD

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: January 2, 2008
• Primary Completion: April 18, 2008
• Study Completion: March 6, 2009
• Last Updated: February 20, 2024

Record last verified: 2007-12

Data Sharing

• IPD Sharing: Will not share