Recruiting

Nutrition

Sponsor:

Concordia University, Montreal

Code:

NCT06680492

Conditions

Obesity, Diabetes, Nutrition, Physical Health

Body Composition Changes

Muscle Function, Handgrip Strength Test

Protein Metabolism

Bariatric Surgery Patients

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06680492

Start date

Jun 23, 2017

Status verified date

Oct, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Sylvia Santosa, PhD, R.D.

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

Locations

Montreal General Hospital (MUHC)

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

José A. Morais, M.D., PhD

514-843-1665jose.morais@mcgill.ca

More Information

Sponsor

Concordia University, Montreal

Last update posted

Nov 8, 2024

Last verified

Oct, 2024

Keywords

  • Obesity
  • Bariatric sugery
  • Protein function
  • Muscle function
  • 6-Minute Walk Test
  • Handgrip Strength Test
  • Nutritional needs
  • Nutritional guides
  • Nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Concordia University, Montreal on 2024-11-08.