ClinicalTrials.gg
RecruitingNCT07809152Updated Sep 9, 2026

Collagen Supplements and Post-MBS Muscle Mass/Body Image

An observational study in Obesity & Overweight, Collagen Protein and Bariatric Surgery, sponsored by Mudanya University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Mudanya University · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 353 studies in Obesity with a site in Turkey — 73 open to participants now, 91 under way, 16 of them phase 3. Obesity · Turkey.

Planned enrollment
116th of 160
52 · median 82
Started
2026
with 59 others
Observational
160 of 353
32 open now
Primary completion
2027-01
later than 52 of 90 live
Registered
313th of 353
by date

Among the 353 studies in Obesity with a site in Turkey, this one is the 116th largest by planned enrollment of the 160 observational ones that give a count, is one of 60 that started in 2026, is one of 160 observational ones, reaches primary completion later than 52 of the 90 other live ones, and was the 313th registered.

Obesity

11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.

Browse Obesity studies →

Open to participants now

73 of the 353 studies in Obesity with a site in Turkey are open now. Recruiting first, the newest first:

67 more — sign in →

All 73 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

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02

Study summary

This prospective, observational cohort study aims to evaluate whether the use of collagen-containing supplements is associated with differences in muscle mass, body composition, and body image among patients who have undergone sleeve gastrectomy (SG). The study will be conducted at the General Surgery outpatient clinic of a private hospital in Bursa, Türkiye, between May 2026 and March 2027, and will enroll adult patients (aged 18-65 years) who meet current ASMBS/IFSO eligibility criteria for metabolic and bariatric surgery.

Participants will be naturally allocated into two observational groups based on their own choice to use or not use collagen-containing supplements; no supplement will be provided or recommended by the study team, and no intervention will be made to participants' standard clinical care. All patients will be followed according to routine clinical practice preoperatively and at 2 weeks, 1 month, 3 months, and 6 months postoperatively.

Primary outcome measures include anthropometric parameters (body weight, BMI, fat mass, fat mass percentage, fat-free mass, muscle mass, percentage of weight loss, percentage of excess weight loss, waist and hip circumference) assessed via bioelectrical impedance analysis (Tanita MC-780 MA), and body image assessed using the Turkish-validated Body Shape Questionnaire (BSQ). Secondary outcomes include biochemical parameters, comorbidities, and macronutrient intake data obtained from 3-day dietary records analyzed using the BEBİS nutrition software.

The study hypothesizes that patients using collagen-containing supplements will show significant differences in muscle mass and body composition parameters compared with non-users, and that supplement use will be significantly associated with BSQ scores. A sample size of approximately 52 participants per group was calculated using G*Power 3.1 (one-way ANOVA, Cohen's f = 0.25, α = 0.05, power = 0.80).

03

Conditions studied

  • Obesity & Overweight
  • Collagen Protein
  • Bariatric Surgery
  • Metabolic and Bariatric Surgery
  • Body Composition
  • Muscle Composition
  • Body Image

Keywords

  • Bariatric Surgery
  • Collagen Supplementation
  • Muscle Mass
  • Body Composition
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult patients aged 18-65 years who underwent sleeve gastrectomy and are under routine postoperative follow-up at the General Surgery outpatient clinic of a private hospital in Bursa, Türkiye. Eligible patients meet current ASMBS/IFSO criteria for metabolic and bariatric surgery (BMI ≥ 35 kg/m², or BMI 30-34.9 kg/m² with an obesity-related metabolic comorbidity). Participants are naturally grouped according to their own preference to use or not use a collagen-containing supplement following surgery.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a ≥ 35 kg/m², regardless of the presence of comorbidities
  • Patients with a BMI of 30-34.9 kg/m² who have an obesity-related metabolic disease and are considered eligible for surgical treatment
  • Patients who have undergone metabolic and bariatric surgery (MBS) in accordance with current ASMBS/IFSO guidelines (Eisenberg et al., 2022)
  • Patients under regular postoperative follow-up
  • Age 18-65 years

Exclusion criteria

Exclusion Criteria:

  • Inflammatory bowel disease
  • History of upper gastrointestinal bleeding
  • Severe psychiatric disorders
  • Active cancer diagnosis
  • Pregnancy or breastfeeding
  • Alcohol or substance dependence
  • Physical limitations preventing participation in exercise
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (estimated)
Patient registry
No

Groups and cohorts

  • 1. Grup

    Group/Cohort Label: Collagen Supplement Users (Kolajen Kullananlar) Description: Participants who, based on their own preference, use a collagen-containing supplement product following sleeve gastrectomy, without any intervention or recommendation from the study team.

    Dietary Supplement: Collagen-containing supplement

  • 2. Grup

    Group/Cohort Label: Non-Users of Collagen Supplement (Kolajen Kullanmayanlar) Description: Participants who do not use any collagen-containing supplement product following sleeve gastrectomy, followed under routine clinical care.

Interventions

  • Dietary supplementCollagen-containing supplement

    Collagen-containing supplement products used at the participants' own discretion following sleeve gastrectomy. The type of product, daily dosage, and duration of use were self-reported by participants

06

What researchers measure

Primary outcomes

  1. Change in Body Weight

    Body weight (kg) measured using a Tanita MC-780 MA device.

    Time frame: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months

  2. Change in Body Shape Questionnaire (BSQ) Score

    Body image concerns were assessed using the Body Shape Questionnaire (BSQ-34), a validated instrument for the Turkish population. This 34-item self-report scale evaluates weight-related concerns and dissatisfaction with body shape over the preceding four weeks. Each item is scored from 1 (never) to 6 (always), with a total score range of 34 to 204. Higher scores indicate greater dissatisfaction with body shape, i.e., a worse outcome.

    Time frame: Preoperative and postoperative 6 months

  3. Change in Body Mass Index (BMI)

    BMI calculated as body weight (kg) divided by height squared (m²).

    Time frame: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months

  4. Percentage of Total Weight Loss (%TWL)

    Calculated as (preoperative weight - postoperative weight) / preoperative weight × 100.

    Time frame: Postoperative and 6 months

  5. Percentage of Excess Weight Loss (%EWL)

    Calculated as (preoperative weight - postoperative weight) / (preoperative weight - ideal weight) × 100. Ideal body weight was calculated assuming a BMI of 25 kg/m².

    Time frame: Postoperative and 6 months

  6. Change in Fat Mass

    Fat mass (kg) assessed by multi-frequency bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.

    Time frame: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months

  7. Change in Fat Mass Percentage

    Fat mass expressed as a percentage of total body weight, assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.

    Time frame: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months

  8. Change in Muscle Mass

    Muscle mass (kg) assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.

    Time frame: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months

  9. Change in Muscle Mass Percentage

    Muscle mass expressed as a percentage of total body weight, assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.

    Time frame: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months

Secondary outcomes

  1. Change in Fasting Blood Glucose

    Fasting blood glucose (mg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  2. Change in Fasting Insulin

    Fasting insulin (µIU/mL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  3. Change in HbA1c

    Glycated hemoglobin (HbA1c, %) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  4. Change in LDL Cholesterol

    LDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  5. Change in HDL Cholesterol

    HDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  6. Change in Triglycerides

    Triglycerides (mg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and postoperative 6 months

  7. Change in Total Cholesterol

    Total cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and postoperative 6 months

  8. Change in ALT

    Alanine aminotransferase (ALT, U/L) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  9. Change in AST

    Aspartate aminotransferase (AST, U/L) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  10. Change in Uric Acid

    Uric acid (mg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  11. Change in Urea

    Urea (mg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  12. Change in Hemoglobin

    Hemoglobin (g/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  13. Change in Hematocrit

    Hematocrit (%) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  14. Change in Ferritin

    Ferritin (ng/mL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  15. Change in Serum Iron

    Serum iron (µg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  16. Change in Vitamin B12

    Vitamin B12 (pg/mL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  17. Change in Folic Acid

    Folic acid (ng/mL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  18. Change in Magnesium

    Magnesium (mg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  19. Change in Total Calcium

    Total calcium (mg/dL) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  20. Change in Serum Sodium

    Serum sodium (mEq/L) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

  21. Change in Serum Potassium

    Serum potassium (mEq/L) obtained from routine clinical laboratory follow-up.

    Time frame: Preoperative and 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared, as this was not planned or consented to as part of the study protocol. Data confidentiality was assured to participants at the time of enrollment, and no data sharing infrastructure or agreement is in place beyond the study team.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.

Of 792 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 6 months is below that.

Counting every sponsor, half of 837 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2026
First posted
Sep 9, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Jan 10, 2027
CompletionEst.
Feb 10, 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07809152
Lead sponsor
Mudanya University
Responsible party
Seher Şen (Assist. Prof. Dr., Mudanya University) — Principal investigator
First posted
Sep 9, 2026
Start date
Jul 1, 2026
Primary completion
Jan 10, 2027 (estimated)
Completion
Feb 10, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Seher Şen, Assistant Professor
Contact
seherdalli@gmail.com
+905393919700
Emre Şen, Master's degree graduate
Contact
0 532 163 30 87

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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