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Trial record 1 of 1 for:    NCT02945475
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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

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.

Condition or disease
Appetitive Behavior Obesity

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.

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Study Type : Observational
Actual Enrollment : 114 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neural Mechanisms for Appetitive Responses to High Reward Foods
Study Start Date : February 2016
Actual Primary Completion Date : March 13, 2020
Actual Study Completion Date : March 13, 2020

Group/Cohort
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



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Biospecimen Retention:   Samples With DNA
Blood Samples


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945475


Locations
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United States, California
Alexandra Yunker
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Kathleen Page, MD University of Southern California
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Responsible Party: Kathleen Page, Associate Professor of Medicine, University of Southern California
ClinicalTrials.gov Identifier: NCT02945475    
Other Study ID Numbers: HS-09-00395
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Keywords provided by Kathleen Page, University of Southern California:
functional magnetic resonance imaging
eating behavior
sugar