The Effects of GLP-1 Receptor Agonists on Chemosensory Function and Ingestive Behavior
The Effects of GLP-1 Receptor Agonists on Sensory Systems and Ingestive Behavior
The goal of this study is to explore whether of GLP-1 receptor agonist use is associated with differences in taste, smell, food preferences, appetite, food cravings, and responses to food cues in adults. The study includes adults who are not currently taking a GLP-1 receptor agonist but may be eligible to use one, and adults who are already taking a GLP-1 receptor agonist as part of their regular medical care for approximately 1 month or approximately 6 months.
The main questions it aims to answer are:
Are taste and smell function different among adults who are not taking a GLP-1 receptor agonist and adults who have been taking one for different lengths of time? Are food preferences, appetite, food cravings, food reward, attention to food cues, and salivary responses to food cues different among these groups? Researchers will compare adults not currently taking a GLP-1 receptor agonist with adults taking a GLP-1 receptor agonist for approximately 1 month or approximately 6 months. The research team will not prescribe, assign, or provide GLP-1 receptor agonist medications.
People in the study will attend two in-person study visits, complete taste and smell tests, complete food preference and computer-based tasks, and provide saliva samples during a food cue task. Questionnaires about appetite, cravings, food cues, and eating behavior will be completed at home over approximately 2 weeks.
연구 개요
상세 설명
This cross-sectional study examines associations between GLP-1 receptor agonist use, chemosensory function, and ingestive behavior in adults. People enrolled in the study are classified into groups based on GLP-1 receptor agonist use status and duration of use: adults who are not currently taking a GLP-1 receptor agonist but may be eligible to use one, adults taking a GLP-1 receptor agonist for approximately 1 month, and adults taking a GLP-1 receptor agonist for approximately 6 months.
GLP-1 receptor agonist use is not assigned by the research team. People who are taking these medications are using them as part of their regular medical care. The study team does not prescribe, administer, or change GLP-1 receptor agonist treatment.
Study procedures include assessments of taste and smell function, food preferences, food reward, appetite, food cravings, food cue responsivity, attentional responses to food cues, and salivary responses to a food cue. Outcomes will be compared across groups to explore whether GLP-1 receptor agonist use and duration of use are associated with differences in chemosensory function and ingestive behavior.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Indiana
-
West Lafayette, Indiana, 미국, 47906
- Purdue University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Ages 18 to 65 years.
- Any sex or gender.
- Body Mass Index (BMI) >30 kg/m².
- Stable medication use, excluding weight management medications other than GLP-1 receptor agonist use as part of regular medical care.
- Eligible to take GLP-1 receptor agonists but not yet started treatment, or currently taking GLP-1 receptor agonists for weight management for approximately 1 month (±0.5 months) or approximately 6 months (±0.5 months).
- No known sensitivity or allergy to study solutions or foods, including sweet solutions, salty solutions, sour solutions, bitter solutions, fatty stimuli, common food flavors used in testing, milk, and fruit-flavored beverages.
Exclusion Criteria:
- Younger than 18 years or older than 65 years.
- Previous bariatric surgery or planned bariatric surgery within the next year.
- Sensitivity or allergy to study foods, taste solutions, odor stimuli, or food-related test materials.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Pre-use / Not Currently Taking GLP-1RA
Adults who are not currently taking a GLP-1 receptor agonist but may be eligible to use one based on body weight criteria (BMI > 30).
Participants in this group are not assigned to GLP-1 receptor agonist treatment by the study team.
|
|
Approximately 1 Month GLP-1RA Use
Adults who have been taking a GLP-1 receptor agonist as part of their regular medical care for approximately 1 month.
GLP-1 receptor agonist use is not assigned, prescribed, or modified by the study team.
|
|
Approximately 6 Months GLP-1RA Use
Adults who have been taking a GLP-1 receptor agonist as part of their regular medical care for approximately 6 months.
GLP-1 receptor agonist use is not assigned, prescribed, or modified by the study team.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Taste Detection Thresholds
기간: During study participation, up to 2 weeks
|
Taste detection thresholds will be assessed for sweet, salty, sour, and bitter stimuli (sucrose, sodium chloride, citric acid, and urea, respectively) using a two-alternative forced-choice staircase procedure, in which participants identify which of two samples contains the taste stimulus.
Separate outcomes will be reported for each taste quality: sweet, salty, sour, and bitter.
For each taste quality, the threshold will be calculated as the geometric mean concentration at which the stimulus is reliably detected and will be reported in mmol/L.
Lower threshold values indicate greater taste sensitivity.
|
During study participation, up to 2 weeks
|
|
Suprathreshold Taste Intensity
기간: During study participation, up to 2 weeks
|
Suprathreshold taste intensity will be assessed for sweet, salty, sour, and bitter stimuli (sucrose, sodium chloride, citric acid, and urea, respectively) using the general Labeled Magnitude Scale.
Separate outcomes will be reported for each taste quality and stimulus concentration.
For each taste quality, participants will rate the perceived intensity of suprathreshold stimulus concentrations.
The scale ranges from 0 to 100, with 0 anchored by "no sensation" and 100 anchored by "strongest imaginable sensation of any kind."
Higher scores indicate greater perceived taste intensity.
|
During study participation, up to 2 weeks
|
|
Taste Hedonics
기간: During study participation, up to 2 weeks
|
Taste hedonics will be assessed using a food modification task in which participants create preferred concentrations for sweet, salty, sour, bitter, and fatty stimuli.
Separate outcomes will be reported for each stimulus type: sweet, salty, sour, bitter, and fatty.
For each stimulus type, the outcome will be the preferred concentration selected by the participant.
Higher values indicate preference for a higher concentration of that stimulus and do not necessarily indicate a better or worse outcome.
|
During study participation, up to 2 weeks
|
|
Fat Taste Intensity Rating
기간: During study participation, up to 2 weeks
|
Fat taste perception will be assessed using edible strips containing different concentrations of linoleic acid.
Participants will rate the perceived intensity of each strip using the general Labeled Magnitude Scale.
Separate outcomes will be reported for each linoleic acid concentration.
The scale ranges from 0 to 100, with 0 anchored by "no sensation" and 100 anchored by "strongest imaginable sensation of any kind."
Higher scores indicate greater perceived fat taste intensity.
|
During study participation, up to 2 weeks
|
|
ArOMa-T Olfactory Test Performance
기간: During study participation, up to 2 weeks
|
Olfactory function will be assessed using the ArOMa-T test.
Participants will smell odor stimuli and provide computer-based responses to questions assessing olfactory performance.
The outcome will be the ArOMa-T test score, with higher scores indicating better olfactory performance.
|
During study participation, up to 2 weeks
|
|
SCENTinel Olfactory Test Performance
기간: During study participation, up to 2 weeks
|
Olfactory function will be assessed using the SCENTinel test.
Participants will smell odor stimuli and provide computer-based responses to questions assessing odor detection, odor identification, odor intensity, and odor pleasantness.
Separate outcomes will be reported for each SCENTinel component.
Higher scores indicate better odor detection or identification performance, greater perceived odor intensity, or greater perceived odor pleasantness, depending on the component assessed.
|
During study participation, up to 2 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Food Preferences
기간: During study participation, up to 2 weeks
|
Food preferences will be assessed using the Leeds Food Preference Questionnaire.
Participants will view food images and rate how much they like and want to eat each food item.
Ratings will be used to assess explicit liking and wanting for foods.
|
During study participation, up to 2 weeks
|
|
Attentional Bias to Food Cues
기간: During study participation, up to 2 weeks
|
Attentional bias to food cues will be assessed using a Food Stroop Task.
Participants will view food-related and non-food words and respond to the color of each word while ignoring the meaning of the word.
Response patterns will be used to assess attentional bias toward food-related cues.
|
During study participation, up to 2 weeks
|
|
Questionnaire-Based Measures of Food Cravings, Food Cue Responsivity, Food Noise, and Eating Behavior
기간: During study participation, up to 2 weeks
|
Questionnaire-based measures will be used to assess food cravings, food cue responsivity, food-related intrusive thoughts, perceived food reward, and eating behavior.
Participants will complete the Food Cue Responsivity Scale, the Modified Trait and State Food Cravings Questionnaires, the Power of Food Scale, the Food Noise Questionnaire, and the Reasons Individuals Stop Eating Questionnaire.
These questionnaires will assess sensitivity to food-related cues, typical and momentary food cravings, food-related intrusive thoughts, perceived responsiveness to the food environment, and reasons for stopping eating, including motivations and physical cues related to meal termination and satisfaction.
|
During study participation, up to 2 weeks
|
|
Dietary Intake
기간: During study participation, up to 2 weeks
|
Dietary intake will be assessed using ASA24, the Automated Self-Administered 24-Hour Dietary Assessment Tool.
Participants will complete three 24-hour dietary recalls on different days, including two weekdays and one weekend day, to report foods and beverages consumed over the previous 24 hours.
|
During study participation, up to 2 weeks
|
|
Cephalic-Phase Salivary Response
기간: During study participation, up to 2 weeks
|
Cephalic-phase salivary response will be assessed by measuring saliva production at baseline and during exposure to a food cue.
Saliva will be collected during a baseline period and again while participants simulate eating a food item by focusing on its smell, taste, and texture.
Saliva will be collected in graduated tubes and weighed to quantify salivary output.
Change in salivation from baseline to food cue exposure will be compared across groups.
|
During study participation, up to 2 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Richard D Mattes, PhD, RD, MPH, Purdue University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-2024 - 1407
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .