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OpenTrials
Completed

NCT Number: NCT06267677

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High protein liquid formula

Dietary Supplement

liquid and high amount of protein

Primary outcomes

  1. protein intake

    Time frame: 2 months

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

  2. evaluate nutritional deficiencies

    Time frame: 2 months

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

  3. Tolerance

    Time frame: 2 months

    Gastrointestinal tolerance during the first two months after surgery.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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