Clinical trial NCT06680492: The Role of Nutrition in Muscle Function of Bariatric Surgery Patients
Official title: The Role of Nutrition in Muscle Function of Bariatric Surgery Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Diabetes, Nutrition, Physical Health
Body Composition Changes
Muscle Function, Handgrip Strength Test
Protein Metabolism
Bariatric Surgery Patients
Keywords: Obesity
Bariatric sugery
Protein function
Muscle function
6-Minute Walk Test
Handgrip Strength Test
Nutritional needs
Nutritional guides
Nutrition
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
Collaborators: name: Montreal General Hospital
First posted: 2024-11-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change in weight
timeFrame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
measure: Change in BMI
timeFrame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
measure: Change in fat mass
timeFrame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
measure: Change in overall body fat percentage
timeFrame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
measure: Resting Energy Expenditure
timeFrame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
measure: Substrate Oxidation
timeFrame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
measure: Nurition and Protein Intake
timeFrame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
measure: Hormone and Inflammatory Marker Assays
timeFrame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital (MUHC)
state: Quebec
Study officials:
References: