Obesity, Diabetes, Nutrition, Physical HealthNCT06680492
The Role of Nutrition in Muscle Function of Bariatric Surgery Patients
An observational study of Obesity, Diabetes, Nutrition, Physical Health and Body Composition Changes, run by Concordia University, Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Nutrition, Physical Health, Body Composition Changes, Muscle Function, Handgrip Strength Test
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jun 2017to Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal General Hospital (MUHC)
Montreal, Quebec, H3G 1A4
José A. Morais, M.D., PhD, 514-843-1665, jose.morais@mcgill.ca
About this study
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.
- 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
- Medical subject headings
- Obesity, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Overall weight loss (kg)
Measured: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Change in BMI
Height and weight will be measured and combined to report BMI (kg/m^2).
Measured: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Change in fat mass
Body composition is measured by dual-energy x-ray absorptiometry.
Measured: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Change in overall body fat percentage
Body composition is measured by dual-energy x-ray absorptiometry.
Measured: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Resting Energy Expenditure
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.
Measured: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Substrate Oxidation
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.
Measured: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Nurition and Protein Intake
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.
Measured: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Hormone and Inflammatory Marker Assays
The inflammatory cytokines, chemokines, and adipokines in blood will be measured using Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start23 Jun 2017
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, Diabetes, Nutrition, Physical HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal General Hospital
- Responsible party
- Principal investigator, Sylvia Santosa, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680492
- Sponsor's protocol ID
- 90000088
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nutrition in Muscle Function of Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT06680492
- Acronym / sponsor ID
- 90000088
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Collaborators
- Montreal General Hospital
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in weight
Time frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.
Overall weight loss (kg)
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).
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.
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.
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.
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.
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Diabetes, Nutrition, Physical Health and Body Composition Changes, run by Concordia University, Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvia Santosa, PhD, R.D. (514-848-2424 ext. x5841, s.santosa@concordia.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Baseline (pre-operation), and at 3-months and 6-months post-operation.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.