Appetitive BehaviorNCT02945475
Neural Mechanisms for Appetitive Responses to High Reward Foods
An observational study of Appetitive Behavior and Obesity, run by University of Southern California at 1 site in United States.
Trial summary
This study is aimed at understanding neuroendocrine responses to different types of sugars and how this influences feeding behavior among lean, overweight, and obese individuals. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Obesity
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 13 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants in the greater Los Angeles area will be recruited. Lean, overweight, and obese participants will be recruited.
Who may be able to join
- Age 18-35 years, right-handed, weight change <2% for at least 3 months prior to participation, no history of diabetes or other significant medical problems, fasting glucose <126 mg/dl.
- Lean group: BMI of 19-24.9 kg/m2
- Obese Group: BMI 30-40 kg/m2
- Overweight Group: BMI of 25-29.9 kg/m2
Who cannot join
- Neurological, psychiatric or addiction disorder, fasting glucose ≥126 mg/dl, use of prescription medication (with the exception of contraceptives), tobacco use, contraindications to MRI scanning (detailed in Protection of Human Subjects), fructose intolerance, history of eating disorder, actively trying to lose weight.
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed at understanding neuroendocrine responses to different types of sugars and how this influences feeding behavior among lean, overweight, and obese individuals.
Read the detailed description
The investigators have previously combined functional magnetic resonance imaging (fMRI) with hormonal and behavioral assessments to better understand the impacts of glucose and fructose on appetite and its central regulation in humans and have made important observations in lean individuals linking fructose consumption to overeating and obesity. The investigators now propose to expand this work by examining the impacts of glucose and fructose ingested together (sucrose), as occurs in real life, and by examining effects of a common non-nutritive sweetener, sucralose, on brain and appetitive response. The investigators propose a random-order crossover design to determine the effects of caloric and non-nutritive sweeteners among lean, overweight, and obese participants. The investigators will measure circulating levels of hormones involved in satiety signaling, quantify food intake, and measure brain activity using blood-oxygen level dependent and arterial spin labeling methods and functional connectivity analyses.
- Conditions
- Appetitive Behavior, Obesity
- Keywords
- functional magnetic resonance imaging, eating behavior, sugar
- Medical subject headings
- Appetitive Behavior, Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| obese | Individuals ages 18 to 35 years of age with body mass index (BMI) 30-40 kg/m2 | |
| lean | Individuals ages 18 to 35 years of age with BMI of 19-24.9 kg/m2 | |
| overweight | Individuals ages 18 to 35 years of age with BMI of 25-29.9 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Blood oxygen level-dependent (BOLD) signal responses to food vs non-food cues after ingestion of different types of sugar. BOLD signal responses to food cues will be compared at the level of whole brain and within a priori regions of interest.
These will be compared between ingestion of drinks and at level of whole brain and in regions of interest
Measured: Sessions 1, 2, 3, 4
Cerebral Blood Flow Response
Arterial spin labeling with be used to determine brain areas with relative increases or decreases in CBF after ingestion of sucrose, glucose, or sucralose.
Measured: Sessions 1, 2, 3, 4
Systemic Metabolite and Hormone Responses
The effects of sugar ingestion on changes in systemic metabolite (glucose) and hormone (insulin, GLP-1, leptin, ghrelin, peptide YY) levels will be assessed.
Measured: Sessions 1, 2, 3, 4
Secondary outcomes (3)
Functional Connectivity between regions involved in regulation of food intake
Investigators will perform a physiological-psychological-interaction (PPI) analysis using the nucleus accumbens as the seed to explore brain regions showing increased functional connectivity to the seed during the food-cue task.
Measured: Sessions 1, 2, 3, 4
Appetite Ratings
Ratings of hunger and desire for food in response to food vs non-food cues will be analyzed using a repeated-measures ANOVA with condition (glucose, sucrose, sucralose) and stimulus (food vs non-food) as within-subject factors.
Measured: Sessions 1, 2, 3, 4
Ad Libitum Food Intake
Total calories consumed and percent calories from sugar, fat and protein will be compared between conditions.
Measured: Sessions 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startFeb 2016
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Page, University of Southern California
- Investigators
- Kathleen Page, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945475
- Sponsor's protocol ID
- HS-09-00395
- Status last verified
- Apr 2021
- First submitted
- 28 Jun 2016
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chakravartti SP, Jann K, Veit R, Liu H, Yunker AG, Angelo B, Monterosso JR, Xiang AH, Kullmann S, Page KA. Non-caloric sweetener effects on brain appetite regulation in individuals across varying body weights. Nat Metab. 2025 Mar;7(3):574-585. doi: 10.1038/s42255-025-01227-8. Epub 2025 Mar 26.
PubMed 40140714Smith A, Page KA, Smith KE. Associations between affect dynamics and eating regulation in daily life: a preliminary ecological momentary assessment study. Cogn Emot. 2024 Aug;38(5):818-824. doi: 10.1080/02699931.2024.2323478. Epub 2024 Mar 1.
PubMed 38427387Alves JM, Yunker AG, Luo S, Jann K, Angelo B, DeFendis A, Pickering TA, Smith A, Monterosso JR, Page KA. FGF21 response to sucrose is associated with BMI and dorsal striatal signaling in humans. Obesity (Silver Spring). 2022 Jun;30(6):1239-1247. doi: 10.1002/oby.23432. Epub 2022 May 2.
PubMed 35491674Yunker AG, Alves JM, Luo S, Angelo B, DeFendis A, Pickering TA, Monterosso JR, Page KA. Obesity and Sex-Related Associations With Differential Effects of Sucralose vs Sucrose on Appetite and Reward Processing: A Randomized Crossover Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2126313. doi: 10.1001/jamanetworkopen.2021.26313.
PubMed 34581796Yunker AG, Luo S, Jones S, Dorton HM, Alves JM, Angelo B, DeFendis A, Pickering TA, Monterosso JR, Page KA. Appetite-Regulating Hormones Are Reduced After Oral Sucrose vs Glucose: Influence of Obesity, Insulin Resistance, and Sex. J Clin Endocrinol Metab. 2021 Mar 8;106(3):654-664. doi: 10.1210/clinem/dgaa865.
PubMed 33300990
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms for Appetitive Responses to High Reward Foods
- ClinicalTrials.gov ID
- NCT02945475
- Acronym / sponsor ID
- HS-09-00395
- Conditions
- Appetitive Behavior, Obesity
- Keywords
- functional magnetic resonance imaging, eating behavior, sugar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at understanding neuroendocrine responses to different types of sugars and how this influences feeding behavior among lean, overweight, and obese individuals.
Detailed description
The investigators have previously combined functional magnetic resonance imaging (fMRI) with hormonal and behavioral assessments to better understand the impacts of glucose and fructose on appetite and its central regulation in humans and have made important observations in lean individuals linking fructose consumption to overeating and obesity. The investigators now propose to expand this work by examining the impacts of glucose and fructose ingested together (sucrose), as occurs in real life, and by examining effects of a common non-nutritive sweetener, sucralose, on brain and appetitive response. The investigators propose a random-order crossover design to determine the effects of caloric and non-nutritive sweeteners among lean, overweight, and obese participants. The investigators will measure circulating levels of hormones involved in satiety signaling, quantify food intake, and measure brain activity using blood-oxygen level dependent and arterial spin labeling methods and functional connectivity analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| obese | – | –Individuals ages 18 to 35 years of age with body mass index (BMI) 30-40 kg/m2 |
| lean | – | –Individuals ages 18 to 35 years of age with BMI of 19-24.9 kg/m2 |
| overweight | – | –Individuals ages 18 to 35 years of age with BMI of 25-29.9 kg/m2 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants in the greater Los Angeles area will be recruited. Lean, overweight, and obese participants will be recruited.
Key inclusion criteria (4 listed)
- Age 18-35 years, right-handed, weight change <2% for at least 3 months prior to participation, no history of diabetes or other significant medical problems, fasting glucose <126 mg/dl.
- Lean group: BMI of 19-24.9 kg/m2
- Obese Group: BMI 30-40 kg/m2
- Overweight Group: BMI of 25-29.9 kg/m2
Key exclusion criteria (1 listed)
- Neurological, psychiatric or addiction disorder, fasting glucose ≥126 mg/dl, use of prescription medication (with the exception of contraceptives), tobacco use, contraindications to MRI scanning (detailed in Protection of Human Subjects), fructose intolerance, history of eating disorder, actively trying to lose weight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of Blood oxygen level-dependent (BOLD) signal responses to food vs non-food cues after ingestion of different types of sugar. BOLD signal responses to food cues will be compared at the level of whole brain and within a priori regions of interest.
Time frame: Sessions 1, 2, 3, 4
These will be compared between ingestion of drinks and at level of whole brain and in regions of interest
Cerebral Blood Flow Response
Time frame: Sessions 1, 2, 3, 4
Arterial spin labeling with be used to determine brain areas with relative increases or decreases in CBF after ingestion of sucrose, glucose, or sucralose.
Systemic Metabolite and Hormone Responses
Time frame: Sessions 1, 2, 3, 4
The effects of sugar ingestion on changes in systemic metabolite (glucose) and hormone (insulin, GLP-1, leptin, ghrelin, peptide YY) levels will be assessed.
3 secondary outcomes
Functional Connectivity between regions involved in regulation of food intake
Time frame: Sessions 1, 2, 3, 4
Appetite Ratings
Time frame: Sessions 1, 2, 3, 4
Ad Libitum Food Intake
Time frame: Sessions 1, 2, 3, 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 40140714Chakravartti SP, Jann K, Veit R, Liu H, Yunker AG, Angelo B, Monterosso JR, Xiang AH, Kullmann S, Page KA. Non-caloric sweetener effects on brain appetite regulation in individuals across varying body weights. Nat Metab. 2025 Mar;7(3):574-585. doi: 10.1038/s42255-025-01227-8. Epub 2025 Mar 26.
- Derived from this study: PubMed 38427387Smith A, Page KA, Smith KE. Associations between affect dynamics and eating regulation in daily life: a preliminary ecological momentary assessment study. Cogn Emot. 2024 Aug;38(5):818-824. doi: 10.1080/02699931.2024.2323478. Epub 2024 Mar 1.
- Derived from this study: PubMed 35491674Alves JM, Yunker AG, Luo S, Jann K, Angelo B, DeFendis A, Pickering TA, Smith A, Monterosso JR, Page KA. FGF21 response to sucrose is associated with BMI and dorsal striatal signaling in humans. Obesity (Silver Spring). 2022 Jun;30(6):1239-1247. doi: 10.1002/oby.23432. Epub 2022 May 2.
- Derived from this study: PubMed 34581796Yunker AG, Alves JM, Luo S, Angelo B, DeFendis A, Pickering TA, Monterosso JR, Page KA. Obesity and Sex-Related Associations With Differential Effects of Sucralose vs Sucrose on Appetite and Reward Processing: A Randomized Crossover Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2126313. doi: 10.1001/jamanetworkopen.2021.26313.
- Derived from this study: PubMed 33300990Yunker AG, Luo S, Jones S, Dorton HM, Alves JM, Angelo B, DeFendis A, Pickering TA, Monterosso JR, Page KA. Appetite-Regulating Hormones Are Reduced After Oral Sucrose vs Glucose: Influence of Obesity, Insulin Resistance, and Sex. J Clin Endocrinol Metab. 2021 Mar 8;106(3):654-664. doi: 10.1210/clinem/dgaa865.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Page, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appetitive Behavior and Obesity, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Blood oxygen level-dependent (BOLD) signal responses to food vs non-food cues after ingestion of different types of sugar. BOLD signal responses to food cues will be compared at the level of whole brain and within a priori regions of interest. (time frame: Sessions 1, 2, 3, 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945475, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.