Clinical trial

The Role of Nutrition in Muscle Function of Bariatric Surgery Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT06680492

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Diabetes, Nutrition, Physical Health, Body Composition Changes, Muscle Function, Handgrip Strength Test, Protein Metabolism, Bariatric Surgery Patients

Full registry criteria

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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Change in weightBaseline (pre-operation), and at 3-months and 6-months post-operation.

Overall weight loss (kg)

Change in BMIBaseline (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).

Change in fat massBaseline (pre-operation), and at 3-months and 6-months post-operation.

Body composition is measured by dual-energy x-ray absorptiometry.

Change in overall body fat percentageBaseline (pre-operation), and at 3-months and 6-months post-operation.

Body composition is measured by dual-energy x-ray absorptiometry.

Resting Energy ExpenditureBaseline (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.

Substrate OxidationBaseline (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.

Nurition and Protein IntakeBaseline (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.

Hormone and Inflammatory Marker AssaysBaseline (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 locations

1 locations were listed when this page was built. The first 40 are shown.

Montreal General Hospital (MUHC)🇨🇦 Montreal, Quebec, Canada

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José A. Morais, M.D., PhDContact

Email · Call 514-843-1665