Clinical trial NCT02945475: Neural Mechanisms for Appetitive Responses to High Reward Foods
Official title: Neural Mechanisms for Appetitive Responses to High Reward Foods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appetitive Behavior
Obesity
Keywords: functional magnetic resonance imaging
eating behavior
sugar
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in the greater Los Angeles area will be recruited. Lean, overweight, and obese participants will be recruited.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: Sessions 1, 2, 3, 4
measure: Cerebral Blood Flow Response
timeFrame: Sessions 1, 2, 3, 4
measure: Systemic Metabolite and Hormone Responses
timeFrame: Sessions 1, 2, 3, 4
Secondary outcomes:
measure: Functional Connectivity between regions involved in regulation of food intake
timeFrame: Sessions 1, 2, 3, 4
measure: Appetite Ratings
timeFrame: Sessions 1, 2, 3, 4
measure: Ad Libitum Food Intake
timeFrame: Sessions 1, 2, 3, 4
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Alexandra Yunker
state: California
Study officials:
affiliation: University of Southern California
name: Kathleen Page, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alves 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.
citation: Yunker 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.
citation: Yunker 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.