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NCT Number: NCT06680492

The Role of Nutrition in Muscle Function of Bariatric Surgery Patients

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.

Recruiting

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Key information

Conditions

Obesity, Diabetes, Nutrition, Physical Health Bariatric Surgery Patients Body Composition Changes Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Muscle Function, Handgrip Strength Test Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Protein Metabolism Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal General Hospital (MUHC)

Montreal, Quebec, H3G 1A4, Canada

Location status: Recruiting

Location contact

José A. Morais, M.D., PhD

CONTACT

[email protected]

514-843-1665

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Change in weight

    Time frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.

    Overall weight loss (kg)

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvia Santosa, PhD, R.D.

CONTACT

[email protected]

514-848-2424 ext. x5841

Sponsors and collaborators

Lead sponsor

Concordia University, Montreal

Other

Collaborators

  • Montreal General Hospital

Registry information

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Nov 8, 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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