The Role of Nutrition in Muscle Function of Bariatric Surgery Patients

November 6, 2024 updated by: Sylvia Santosa, Concordia University, Montreal

Current recommendations for protein intake after bariatric surgery are not based on strong scientific evidence. It remains unclear how much protein should be eaten to minimize muscle loss and preserve the metabolism and function of individuals post-bariatric surgery.

The objective of this study is to analyze the relationships between changes in body composition, nutrition and protein intake, and muscle function after bariatric surgery to further our understanding of the nutritional needs of patients after bariatric surgery.

We intend to recruit around 75 participants, men and women, aged between 18 and 65 years. Participants will be recruited from the Bariatric Surgery Clinic, McGill University Health Center.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Recruiting
        • Montreal General Hospital (MUHC)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals living with obesity to undergo primary bariatric surgery from the Montreal area. Individuals to be recruited from the Montreal General Hospital Bariatric Clinic.

Description

Inclusion Criteria:

  • Male and female
  • Aged 18 to 65 years old
  • Undergoing first bariatric surgery (any type)
  • Diabetics and non-diabetics
  • Non-smokers and non-cannabis consumers

Exclusion Criteria:

  • Pregnant and breastfeeding women
  • Individuals undergoing second bariatric surgery
  • Regular smokers and cannabis consumers
  • Current use of Ozempic (or Ozempic-like medication) and anti-psychotic meds
  • Limited physical mobility (using walking aids such as canes, walkers, or wheelchairs) and issues with hand resistance
  • Kidney disease, non-controlled / unstable hypertension and hypothyroidism, and any metabolic disease other than diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Overall weight loss (kg)
Baseline (pre-operation), and at 3-months and 6-months post-operation.
Change in BMI
Time Frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Height and weight will be measured and combined to report BMI (kg/m^2).
Baseline (pre-operation), and at 3-months and 6-months post-operation.
Change in fat mass
Time Frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Body composition is measured by dual-energy x-ray absorptiometry.
Baseline (pre-operation), and at 3-months and 6-months post-operation.
Change in overall body fat percentage
Time Frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Body composition is measured by dual-energy x-ray absorptiometry.
Baseline (pre-operation), and at 3-months and 6-months post-operation.
Resting Energy Expenditure
Time Frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Resting energy expenditure will be measured in a fasted state by indirect calorimetry. The volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the resting energy expenditure.
Baseline (pre-operation), and at 3-months and 6-months post-operation.
Substrate Oxidation
Time Frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Substrate oxidation will be measured in a fasted state by indirect calorimetry. The volume of oxygen, carbon dioxide, and water vapor pressure will be taken into consideration to calculate the respiratory exchange ratio.
Baseline (pre-operation), and at 3-months and 6-months post-operation.
Nurition and Protein Intake
Time Frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
A 3-day food journal and a 24-hour food recall will measure the nutritional profile (protein intake). A 24-hour urine sample will be used to measure urinary nitrogen concentration.
Baseline (pre-operation), and at 3-months and 6-months post-operation.
Hormone and Inflammatory Marker Assays
Time Frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
The inflammatory cytokines, chemokines, and adipokines in blood will be measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Baseline (pre-operation), and at 3-months and 6-months post-operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concordia University, Montreal

Collaborators

Montreal General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2017

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

October 20, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Estimated)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90000088

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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