NCT07290075

Brief Summary

This cross-sectional observational study investigates the association between changes in olfactory and gustatory senses and hedonic hunger among individuals who have undergone bariatric surgery. The study also examines the effects of these sensory changes on diet quality and anthropometric measurements. Participants completed a structured questionnaire including sociodemographic and health information, dietary habits, a modified 33-item taste and smell assessment, the Power of Food Scale (PFS), the Mediterranean Diet Adherence Screener (MEDAS), the International Physical Activity Questionnaire (IPAQ), and anthropometric measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

August 12, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

Hedonic Hungerbariatric surgery outcomesMediterranean DietNutrient AdequacyPower of Food Scale (PFS)Taste and Smell QuestionnaireMEDAS

Outcome Measures

Primary Outcomes (2)

  • Power of Food Scale (PFS) Score

    Hedonic hunger assessed using the Power of Food Scale (range: 1-5; higher scores indicate greater hedonic hunger).

    Baseline (Day 1, at study enrollment)

  • Modified 33-item Taste and Smell Questionnaire Score

    Changes in taste and smell perception assessed using a modified 33-item questionnaire (range: 0-33; higher scores indicate more pronounced sensory changes).

    Baseline (≥3 months after bariatric surgery, at study enrollment)

Secondary Outcomes (7)

  • Mediterranean Diet Adherence Screener (MEDAS) Score

    Baseline (≥3 months after bariatric surgery, at study enrollment)

  • Body Mass Index (BMI)

    Baseline (Day 1, at study enrollment)

  • Waist-to-Hip Ratio (WHR)

    Baseline (Day 1, at study enrollment)

  • Energy Intake Adequacy (% of TÜBER-2022 reference)

    Baseline (Day 1, at study enrollment)

  • Protein Intake Adequacy (% of TÜBER-2022 reference)

    Baseline (Day 1, at study enrollment)

  • +2 more secondary outcomes

Study Arms (2)

Sleeve Gastrectomy (SG)

Participants who underwent sleeve gastrectomy at least 3 months prior to enrollment.

Other: Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB)

Roux-en-Y Gastric Bypass (RYGB)

Participants who underwent Roux-en-Y gastric bypass at least 3 months prior to enrollment.

Other: Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB)

Interventions

Participants who have undergone sleeve gastrectomy ≥3 months prior to study enrollment; and Participants who have undergone Roux-en-Y gastric bypass ≥3 months prior to study enrollment.

Roux-en-Y Gastric Bypass (RYGB)Sleeve Gastrectomy (SG)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18-65 years who have undergone bariatric surgery (Sleeve Gastrectomy or Roux-en-Y Gastric Bypass) at least 3 months prior to enrollment, recruited from patients followed in clinical nutrition and bariatric surgery outpatient clinics.

You may qualify if:

  • Adults aged 18 to 65 years
  • History of bariatric surgery (Sleeve Gastrectomy or Roux-en-Y Gastric Bypass)
  • At least 3 months post-surgery at the time of study enrollment
  • Able and willing to provide informed consent

You may not qualify if:

  • Pregnancy
  • History of neurological disorders affecting taste or smell
  • Active upper respiratory infection at the time of assessment
  • Severe psychiatric disorders that may impair participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism

Istanbul, Capa, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityTaste DisordersOlfaction Disorders

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSensation DisordersNeurologic ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Registered dietitians

Study Record Dates

First Submitted

August 12, 2025

First Posted

December 17, 2025

Study Start

January 1, 2024

Primary Completion

November 30, 2024

Study Completion

January 31, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

No - Individual participant data (IPD) will not be shared due to privacy concerns and lack of prior consent for public data sharing from study participants. Only aggregated results will be available in publications.

Locations