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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.
Bariatric surgery is an effective method for treating obesity, but a significant decrease in skeletal muscle mass can be observed in the early postoperative period. This loss of muscle mass can negatively affect physical functions, reduce metabolic rate, and make long-term weight maintenance more difficult. Therefore, developing strategies to prevent muscle loss after bariatric surgery is of great clinical importance.
The use of whey protein to support muscle protein synthesis in the postoperative period is a common practice. In recent years, there has been increased scientific interest in the potential of collagen peptides, especially when used in conjunction with resistance exercise, to contribute to muscle mass preservation. However, studies evaluating the combined effect of collagen supplementation and exercise programs in addition to whey protein in individuals undergoing bariatric surgery are limited.
This clinical study aims to investigate the effectiveness of adding collagen to standard whey protein supplementation and a resistance exercise program in preventing muscle loss. Four different groups will be designed to evaluate the independent and combined effects of collagen and exercise:
All participants will follow a standard post-bariatric surgery nutrition protocol and receive routine vitamin and mineral supplements. The resistance exercise program will begin four weeks after surgery; it will consist of progressively more intense, supervised exercises targeting large muscle groups. Body composition assessments will be performed at baseline and at specified follow-up weeks. The primary outcome measure is change in skeletal muscle mass; secondary outcome measures are fat mass, functional capacity, and exercise compliance.
This study is expected to contribute to the identification of optimal nutrition and exercise strategies to reduce muscle loss after bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (CG) | Active Comparator | Whey protein supplementation will be provided. Vitamin and mineral supplementation will be administered. No resistance exercise will be performed. Participants will follow bariatric surgery nutrition guidelines and maintain their regular physical activities. A comparison will be made with the other groups as the control group. |
|
| Whey Protein + Collagen + Exercise Group (WPCEG) | Experimental | Collagen-containing whey protein supplementation will be provided. Vitamin and mineral supplementation will be given. Resistance exercises will be performed. Participants will follow bariatric surgery nutrition guidelines and maintain their physical activities. They will begin the resistance exercise program in the 4th week after surgery. |
|
| Whey Protein + Collagen + Non-Exercise Group (WPCG) | Experimental | Collagen-containing whey protein supplementation will be provided. Vitamin and mineral supplementation will be administered. No resistance exercises will be performed. Participants will follow bariatric surgery nutrition guidelines and maintain their physical activities. |
|
| Whey Protein + Exercise Group (WPEG) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein supplement | Dietary Supplement | Oral whey protein supplement provided daily according to bariatric surgery nutrition protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (preoperative), postoperative week 4 (day 29), and postoperative week 12 (day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, week 4, and week 12 |
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Inclusion Criteria:
Exclusion Criteria:
man and woman
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rüken A Samancı, Msc | Contact | +90 543 939 15 94 | rasamanci@medipol.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Halit E Taşkın, Dr. | Cerrahpaşa Faculty of Medicine, General Surgery | Principal Investigator |
| Nihal Z Erdem, PhD | Istanbul Medipol University, Nutrition and Dietetics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Recruiting | Istanbul | Fatih | Turkey (Türkiye) |
Individual participant data will not be shared because this study involves identifiable clinical and nutritional data collected at a single center, and participant privacy cannot be fully ensured despite anonymization
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Whey protein supplementation will be provided. Vitamin and mineral supplementation will be given. Resistance exercises will be performed. Participants will follow bariatric surgery nutrition guidelines and maintain their physical activities. They will begin the resistance exercise program in the 4th week after surgery. |
|
| Hydrolyzed Collagen Supplement | Dietary Supplement | Oral hydrolyzed collagen supplement provided daily in combination with whey protein. |
|
| Vitamin and Mineral Supplementation | Dietary Supplement | Routine vitamin and mineral supplementation according to bariatric surgery follow-up protocol. |
|
| Resistance Exercise Program | Behavioral | Structured resistance exercise program initiated at postoperative week 4, supervised, 3 times per week. |
|
| Bürke Köksalan, PhD |
| Principal Investigator |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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