Neural Mechanisms for Appetitive Responses to High Reward Foods

April 17, 2021 updated by: Kathleen Page, University of Southern California
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Alexandra Yunker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Sessions 1, 2, 3, 4
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.
Sessions 1, 2, 3, 4
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.
Sessions 1, 2, 3, 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Sessions 1, 2, 3, 4
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.
Sessions 1, 2, 3, 4
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.
Sessions 1, 2, 3, 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Kathleen Page, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

March 13, 2020

Study Completion (Actual)

March 13, 2020

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 17, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HS-09-00395

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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