Preventing Muscle Loss After Bariatric Surgery: Protein-Collagen Supplementation and Resistance Exercise
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorMedipol University
About this trial
The aim of this clinical trial is to investigate the effectiveness of collagen, considered a new approach to prevent muscle mass loss after bariatric surgery, and to demonstrate the relationship between this effect and exercise. The key questions it aims to answer are:
Does whey protein supplementation with collagen combined with resistance exercise prevent muscle mass loss after bariatric surgery? Do whey protein supplementation with collagen combined with resistance exercise affect fat mass after bariatric surgery?
Researchers will compare collagen with whey protein.
The study groups and interventions to be implemented are summarized below:
Group 1: Control Group (CG; n: 10) Whey protein supplementation will be administered Vitamin and mineral supplementation will be administered No resistance exercise will be performed The participants will eat according to bariatric surgery nutrition guidelines and perform physical activities.
Group 2: Whey Protein + Collagen + Exercise Group (WPCEG; n: 10) Whey protein supplements with collagen will be given. Vitamin and mineral supplements will be given. Resistance exercise will be performed. They will eat according to bariatric surgery nutrition guidelines and perform physical activities.
They will begin a resistance exercise program 4 weeks after surgery.
Group 3: Whey Protein + Collagen + No Exercise Group (WPCG; n: 10) Whey protein supplements with collagen will be given. Vitamin and mineral supplements will be given. No resistance exercise will be performed. They will eat according to bariatric surgery nutrition guidelines and perform physical activities.
Group 4: Whey Protein + Exercise Group (WPEG; n: 10) Whey protein supplements will be given. Vitamin and mineral supplements will be given. Resistance exercise will be performed. They will eat according to bariatric surgery nutrition guidelines and perform physical activities.
A resistance exercise program will begin at 4 weeks post-operatively.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being between 20-50 years old
Body mass index; 35 ≤ BMI< 60 kg/m2
Not being pregnant
Not being addicted to alcohol and drugs
Disqualifiers
Having at least one of the following inflammatory bowel diseases, upper gastrointestinal bleeding, advanced psychiatric diseases, cancer, and kidney failure.
using statins
be pregnant
Being addicted to alcohol and drugs
Trial design
Design model
Parallel
Treatments tested in this trial
Whey protein supplement
Dietary supplementOral whey protein supplement provided daily according to bariatric surgery nutrition protocol.
Hydrolyzed Collagen Supplement
Dietary supplementOral hydrolyzed collagen supplement provided daily in combination with whey protein.
Vitamin and Mineral Supplementation
Dietary supplementRoutine vitamin and mineral supplementation according to bariatric surgery follow-up protocol.
Resistance Exercise Program
BehavioralStructured resistance exercise program initiated at postoperative week 4, supervised, 3 times per week.
Treatment groups
35 Participants
are divided into 4 treatment groupsGroup A: Control Group (CG)Active comparator 2 interventions
Group B: Whey Protein + Collagen + Exercise Group (WPCEG)Experimental treatment 4 interventions
Group C: Whey Protein + Collagen + Non-Exercise Group (WPCG)Experimental treatment 2 interventions
Group D: Whey Protein + Exercise Group (WPEG)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change in Skeletal Muscle Mass (kg) Measured by BIA
Skeletal muscle mass (kg) will be measured using a multi-frequency bioelectrical impedance analysis (BIA) device. The outcome will be reported as the mean change from baseline at each time point in each study group.
Time frame
Baseline (preoperative), postoperative week 4 (day 29), and postoperative week 12 (day 85)Secondary outcomes
1
Change in Fat Mass (kg) Measured by BIA
Fat mass (kg) will be measured using BIA. Results will be summarized as the mean change from baseline for each group.
Time frame
Baseline, week 4, and week 12Sponsors and contacts
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Source ClinicalTrials.gov