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

Efficacy of a Specific Complete Formula on Nutritional Status and Coverage of Protein Requirements After Obesity Surgery Compared to the Traditional Progressive Diet: a Prospective Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Body Composition; Bariatric Surgery Candidate; Protein Supplementation
• Intervention / Treatment: Dietary supplement: High protein liquid formula

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High protein liquid formula; 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; liquid and high amount of protein
No Intervention: Standard care diet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2008
• Primary Completion (Actual): April 18, 2008
• Study Completion (Actual): March 6, 2009

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: 2007/3928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No