- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290075
The Relationship Between Olfactory and Gustatory Senses, Hedonic Hunger, and Diet Quality After Bariatric Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity is a chronic, multifactorial disease that negatively impacts health and quality of life. Bariatric surgery is an effective treatment option for severe obesity, leading to significant and sustained weight loss as well as improvement in obesity-related comorbidities.
Postoperative changes in taste and smell perception are frequently reported by bariatric patients and may influence food preferences, hedonic hunger, and overall diet quality. These sensory alterations can result from anatomical and hormonal changes after surgery, including altered gut hormone secretion (e.g., PYY, GLP-1, ghrelin) and bile acid metabolism, which affect appetite regulation and reward pathways.
This cross-sectional observational study evaluated adults aged 18-65 years who had undergone sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) at least three months prior to enrollment. Data collection included sociodemographic and health information, dietary habits, a modified 33-item taste and smell questionnaire, the Power of Food Scale (PFS) to assess hedonic hunger, the Mediterranean Diet Adherence Screener (MEDAS), the International Physical Activity Questionnaire (IPAQ), and anthropometric measurements. Nutrient intakes were analyzed according to the Türkiye Nutrition Guide (TÜBER-2022) reference values.
The primary objective was to determine the relationship between postoperative taste/smell changes and hedonic hunger. Secondary objectives included assessing the association between sensory perception and Mediterranean diet adherence, anthropometric parameters, and nutrient adequacy by surgery type. Findings from this study may guide the development of personalized nutritional follow-up protocols to improve long-term outcomes in bariatric patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Capa
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Istanbul, Capa, Turkey (Türkiye), 34093
- Istanbul University, Faculty of Medicine, Department of Endocrinology and Metabolism
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Sleeve Gastrectomy (SG)
Participants who underwent sleeve gastrectomy at least 3 months prior to enrollment.
|
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)
Participants who underwent Roux-en-Y gastric bypass at least 3 months prior to enrollment.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Power of Food Scale (PFS) Score
Time Frame: Baseline (Day 1, at study enrollment)
|
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
Time Frame: Baseline (≥3 months after bariatric surgery, at study enrollment)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mediterranean Diet Adherence Screener (MEDAS) Score
Time Frame: Baseline (≥3 months after bariatric surgery, at study enrollment)
|
Adherence to the Mediterranean diet assessed using the 14-item MEDAS questionnaire (range: 0-14; higher scores indicate greater adherence).
|
Baseline (≥3 months after bariatric surgery, at study enrollment)
|
|
Body Mass Index (BMI)
Time Frame: Baseline (Day 1, at study enrollment)
|
BMI calculated as weight (kg) / height (m²).
|
Baseline (Day 1, at study enrollment)
|
|
Waist-to-Hip Ratio (WHR)
Time Frame: Baseline (Day 1, at study enrollment)
|
WHR calculated as waist circumference (cm) / hip circumference (cm).
|
Baseline (Day 1, at study enrollment)
|
|
Energy Intake Adequacy (% of TÜBER-2022 reference)
Time Frame: Baseline (Day 1, at study enrollment)
|
Daily energy intake adequacy compared to TÜBER-2022 reference values.
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Baseline (Day 1, at study enrollment)
|
|
Protein Intake Adequacy (% of TÜBER-2022 reference)
Time Frame: Baseline (Day 1, at study enrollment)
|
Daily protein intake adequacy compared to TÜBER-2022 reference values.
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Baseline (Day 1, at study enrollment)
|
|
Micronutrient Intake Adequacy (e.g., iron, folate, vitamin E; % of TÜBER-2022 reference)
Time Frame: Baseline (Day 1, at study enrollment)
|
Micronutrient intake adequacy compared to TÜBER-2022 reference values.
|
Baseline (Day 1, at study enrollment)
|
|
Nutrient Adequacy Score (based on TÜBER-2022 reference values)
Time Frame: Baseline (Day 1, at study enrollment)
|
Composite score reflecting the percentage adequacy of daily energy, macronutrient, and micronutrient intakes compared to TÜBER-2022 reference values.
Higher scores indicate greater adequacy.
|
Baseline (Day 1, at study enrollment)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Nutrition Disorders
- Overnutrition
- Body Weight
- Sensation Disorders
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Olfaction Disorders
- Taste Disorders
- Therapeutics
- Surgical Procedures, Operative
- Digestive System Surgical Procedures
- Anastomosis, Surgical
- Bariatric Surgery
- Bariatrics
- Obesity Management
- Gastroenterostomy
- Gastric Bypass
Other Study ID Numbers
- USK-NUTR-HK01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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