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Neural Mechanisms for Appetitive Responses to High Reward Foods

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ClinicalTrials.gov Identifier: NCT02945475
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Kathleen Page, University of Southern California

Tracking Information
First Submitted Date June 28, 2016
First Posted Date October 26, 2016
Last Update Posted Date April 20, 2021
Study Start Date February 2016
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2021)
  • 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.
Original Primary Outcome Measures
 (submitted: October 24, 2016)
  • Changes of Blood oxygen level-dependent (BOLD) signal responses to 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 fructose and ingestion of glucose 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 fructose, or sucralose.
Change History
Current Secondary Outcome Measures
 (submitted: April 17, 2021)
  • Functional Connectivity between regions involved in regulation of food intake [ Time Frame: Sessions 1, 2, 3, 4 ]
    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.
  • Appetite Ratings [ Time Frame: Sessions 1, 2, 3, 4 ]
    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.
  • Ad Libitum Food Intake [ Time Frame: Sessions 1, 2, 3, 4 ]
    Total calories consumed and percent calories from sugar, fat and protein will be compared between conditions.
Original Secondary Outcome Measures
 (submitted: October 24, 2016)
  • Functional Connectivity between regions involved in regulation of food intake [ Time Frame: Sessions 1, 2, 3, 4 ]
    We 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.
  • Systemic Metabolite and Hormone Responses [ Time Frame: sessions 1, 2, 3, 4 ]
    The effects of sugar ingestion on changes in systemic metabolite (glucose, fructose, lactate) and hormone (insulin, GLP-1, leptin, ghrelin, peptide YY) levels will be assessed.
  • Appetite Ratings [ Time Frame: Sessions 1, 2, 3, 4 ]
    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, fructose, sucrose, sucralose) and stimulus (food vs non-food) as within-subject factors.
  • Ad Libitum Food Intake [ Time Frame: Sessions 1, 2, 3, 4 ]
    Total calories consumed and percent calories from sugar, fat and protein will be compared between conditions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neural Mechanisms for Appetitive Responses to High Reward Foods
Official Title Neural Mechanisms for Appetitive Responses to High Reward Foods
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood Samples
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.
Condition
  • Appetitive Behavior
  • Obesity
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 17, 2021)
114
Original Estimated Enrollment
 (submitted: October 24, 2016)
120
Actual Study Completion Date March 13, 2020
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02945475
Other Study ID Numbers HS-09-00395
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kathleen Page, University of Southern California
Study Sponsor University of Southern California
Collaborators Not Provided
Investigators
Principal Investigator: Kathleen Page, MD University of Southern California
PRS Account University of Southern California
Verification Date April 2021