The Role of Nutrition in Muscle Function of Bariatric Surgery Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity, Diabetes, Nutrition, Physical Health, Body Composition Changes, Muscle Function, Handgrip Strength Test, Protein Metabolism. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Change in weight [Time frame: 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.]
- Change in fat mass [Time frame: 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.]
- Resting Energy Expenditure [Time frame: 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.]
- Nurition and Protein Intake [Time frame: 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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Canada · 1 center
- Montreal General Hospital (MUHC) — Montreal
Identifiers
NCT: NCT06680492 · 90000088