Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07809152

Collagen Supplements and Post-MBS Muscle Mass/Body Image

Sponsor: Mudanya University

View on ClinicalTrials.gov

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).

Official title: Relationship Between Collagen-Containing Supplement Use and Muscle Mass and Body Image Following Metabolic and Bariatric Surgery: A Prospective Observational Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

52

Start Date

2026-07-01

Completion Date

2027-02-10

Last Updated

2026-09-09

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Collagen-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

Locations (1)

Yıldırım Doruk Hastanesi

Bursa, Yıldırım, Turkey (Türkiye)