The Role of Nutrition in Muscle Function of Bariatric Surgery Patients

NCT06680492 | Recruiting

• 1 other identifier: 90000088
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• Change in weight

  Overall weight loss (kg)

  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).

  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.

  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.

  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.

  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.

  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.

  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).

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concordia University, Montreal: lead
• Montreal General Hospital: collaborator

Study Sites (1)

Montreal General Hospital (MUHC)

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples for the purpose of further laboratory analysis.

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Sylvia Santosa, PhD, R.D.

CONTACT

514-848-2424; s.santosa@concordia.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: November 8, 2024
• Study Start: June 23, 2017
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)