Food Preferences and Craniopharyngiomas

NCT07301554 | Not Yet Recruiting

• 2 other identifiers: APHP2507452025-A02014-45
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Craniopharyngioma

Keywords

Craniopharyngioma; food preferences; changes

Outcome Measures

Primary Outcomes (2)

• 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).

  at baseline

• 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.

  at baseline

Secondary Outcomes (6)

• Evaluation of the Fat Preference

  at baseline

• Evaluate of eating behaviors

  at baseline

• Assessment of physical activity

  at baseline

• Collecte of BMI

  at baseline

• Collecte of Waist Circumference

  at baseline

Study Arms (3)

groups 1: Craniopharyngioma patients

40 adults surgically treated for craniopharyngioma (≥ 3 months post-surgery).

Control participants

80 adults without hypothalamic-pituitary disease, matched on age, sex, and BMI with groups 1 and 2.

groups 2: Pituitary macroadenoma patients

40 adults surgically treated for pituitary macroadenoma with ≥ 2 anterior pituitary hormone deficiencies.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Group 2: patients with pituitary macroadenoma surgery with documented ≥ 2 anterior pituitary deficits.
• Group 3: Follow-up for an endocrine condition without hypothalamo-hypophyseal involvement, acceptable conditions (thyroid nodule without dysthyroidism, PCOS, peripheral hirsutism, calcium metabolism disorders), no known treatments or prior medical history likely to influence eating behaviour.

You may not qualify if:

• phase 1: Type 1 or type 2 diabetes, Active smoking, alcohol misuse, drug use, diagnosed psychiatric disorders or eating behaviour disorders.
• Phase 2:
• Person benefiting from State Medical Aid (AME).
• Control group:
• Hypothalamo-hypophyseal pathology, type 1 or type 2 diabetes, uncontrolled hyperthyroidism or hypothyroidism, adrenal hormone hypersecretion disorder, history of or ongoing treatment for active cancer.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of endocrinology, diabetology and nutrition, Ambroise Paré Hospital - APHP

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Craniopharyngioma; Food Preferences

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Feeding Behavior; Behavior

Study Officials

• Mirella Hage, MD, PhD

  Department of endocrinology, diabetology and nutrition, Ambroise Paré Hospital - A

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirella Hage, MD, PhD

CONTACT

+ 33 01 49 09 54 95; mirella.hage@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 24, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)