Food Preferences and Craniopharyngiomas
ConditionCraniopharyngioma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The hypothalamus plays a key role in regulating appetite, satiety, and energy balance. When tumors such as craniopharyngiomas develop in this region, they can disrupt these mechanisms and lead to a form of severe weight gain known as hypothalamic obesity. Several factors play a role in the development of hypothalamic obesity that is often resistant to traditional treatments. Changes in food preferences notably a higher liking for food rich in fat and sugar may be implicated as has been reported in common obesity.
The working hypothesis of the study is that hypothalamic lesions may alter food preferences, leading to an increased preference for high-fat and high-sugar foods, and that these changes in dietary choices contribute among other factors to the development of hypothalamic obesity.
By providing the first evaluation of food preferences in adults treated surgically for craniopharyngiomas, this study will shed light on the role of hypothalamic lesions in modifying dietary choices. The results may help explain why some patients experience rapid and resistant weight gain, and could guide future strategies to better manage hypothalamic obesity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Common inclusion criteria: complete medical record accessible, capacity to understand and complete self-administered questionnaires, agreement to complete the questionnaires at the time of inclusion, adult subject, not in an emergency situation, provision of non-opposition (opt-out consent documented), affiliation to a social security scheme.
Disqualifiers
Common exclusion criteria: bariatric surgery, GLP-1 agonist treatment, chronic disease affecting alimentation, pregnancy or breastfeeding, specific diets (gluten-free, vegetarian, vegan...), refusal or opposition to data use, vulnerability status (under guardianship or legal protection) or inability to complete questionnaires or to understand the proposed research or to express a clear opinion regarding non-opposition.
Trial population
Phase 1 : Adult French residents aged 18 - 74 years from the general population (n=186) for FPQ validation (recruited among hospital staff, patients, accompanying persons). Phase 2 : Adults aged 18 - 74 years in three groups (40 patients with craniopharyngiomas, 40 matched patients with macroadenomas with ≥2 hormonal deficits , 80 matched controls); total n=160 for phase 2. Overall total across phases = 346 subjects.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
346 Participants
are grouped into 3 trial groupsGroup A: groups 1: Craniopharyngioma patients
Group B: Control participants
Group C: groups 2: Pituitary macroadenoma patients
Trial outcomes
Primary outcomes
1
Psychometric validation of the French food preference questionnaire (FPQ): phase 1
Validation of the French version of the Food Preference Questionnaire (FPQ) in an adult population in France. The Food Preference Questionnaire (FPQ) is the primary tool used to evaluate participants' food preferences for 62 food items, such as meats, dairy products, cereals, fruits, vegetables, and snack foods. For each item, participants indicate their degree of liking using a 6-point response scale from "dislike strongly" to "like strongly" ("Do not like at all", "Dislike moderately", "Neutral", "Like a little", "Like very much", "Not applicable"), allowing quantification of preference intensity across food types. Validity will be evaluated through exploratory and confirmatory factor analyses, while reliability will be assessed using internal consistency (Cronbach's alpha coefficient) and reproducibility (test-retest).
Time frame
at baseline2
Evaluation of scores measuring FPQ: phase 2
The main objective is to characterize food preferences in patients operated on for a craniopharyngioma by comparing them with two control groups: patients operated on for a pituitary macroadenoma with anterior pituitary insufficiency, and a control population matched for age, sex, and body mass index (BMI), calculated as mass (kg) /(height in m)\^2. The questionnaire validated in phase 1 will be used and questionnaire results will be analyzed quantitatively to identify specific food preference profiles within each group and to explore potential associations with clinical and metabolic parameters.
Time frame
at baselineSecondary outcomes
1
Evaluation of the Fat Preference
Phase 2 : Evaluation of the liking and consumption frequency between higher-fat and lower-fat versions of common foods (e.g., baked potato versus French fries, full-fat versus reduced-fat ice cream). It uses forced-choice items with three components per food pair : "have you eaten this food?", "which tastes better?", and "which do you eat most often?".
Time frame
at baseline2
Evaluate of eating behaviors
Phase 2 : Tool: Dutch Eating Behavior Questionnaire (DEBQ). Assessment of eating behaviors (emotional, restrained, external). The DEBQ has been translated and validated in 14 languages, including French. Each item uses a 5-point scale ("Never", "Rarely", "Sometimes", "Often", "Very often"). Higher scores indicate higher levels of the corresponding eating behavior.
Time frame
at baseline3
Assessment of physical activity
Phase 2: Tool: International Physical Activity Questionnaire (IPAQ) Measurement of physical activity level over the previous 7 days. Higher scores reflect higher physical activity levels. It has been validated in several languages, including French.
Time frame
at baseline4
Collecte of BMI
Body Mass Index (BMI): BMI = (weight (kg)/(height in m)\^2)
Time frame
at baselineSponsors and contacts
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Source ClinicalTrials.gov
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