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临床试验/NCT03490734
NCT03490734已完成不适用

Neurobehavioral Plasticity to Regular Sugar-Sweetened Beverage Intake: An fMRI Experiment

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo

研究概览

简要总结

The proposed project will examine the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB).

详细描述

The proposed project addresses critical gaps in the understanding of the strength, specificity and persistence of neurobehavioral adaptions that occur in the initial period of repeated consumption of a branded sugar sweetened beverage (SSB). Half of Americans consume SSBs on any given day.

Regular SSB intake is considered a contributing factor to excess energy intake, weight gain, and obesity, which impacts 70% of Americans. A contributing factor to repeated SSB consumption is sugar intake causes the release of dopamine (DA) and opioids in the striatum, providing positive reinforcement. As such, multiple brain-based models of food reward-driven obesity have been proposed, largely focusing on the striatum and executive functioning. These brain-based models of obesity have elucidated risk factors for overconsumption of high-sugar foods; however, data supporting these competing models rely heavily on observational studies in small samples.

Importantly, previous reports from the investigators lab and others directly implicate eating behavior patterns as a vital contributor to aberrant neurobehavioral responses to food stimuli. However, without experimental evidence, there are fundamental gaps in the investigators knowledge about the neurobehavioral adaptations that occur as an individual begins to regularly consume a SSB prior to weight change.

As observational data suggest, it is also crucial to examine individual difference factors that may exacerbate or protect against adaptations associated with regular SSB intake, as well as whether these adaptions are specific.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

盲法说明

Experimental and flavor conditions will be blinded to those performing analyses.

入排标准

年龄范围
18 Years 至 28 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Potential participants will be eligible for the study if they have BMI scores between the 18 and 34 at baseline.

排除标准

  • •Individuals with probable current Axis I psychopathology or any fMRI contra-indicators (e.g., metal implants, braces) will be excluded. Those with a probable Axis I diagnosis will be provided with treatment referral information and encouraged to seek treatment,
  • •current regular use (3 or more times a week) of psychoactive drugs (e.g., cocaine, marijuana, nicotine),
  • •regular smoking,
  • •serious medical problems (e.g., cancer, diabetes),
  • •dietary practices that do not allow intake of intervention beverages.

研究组 & 干预措施

Beverage A (Sweetened)

Active Comparator

One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks.

MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

干预措施: Black Cherry and Orange Flavored Beverage with added sugar (Dietary Supplement)

Beverage B (Sweetened)

Active Comparator

One quarter of the group to receive strawberry kiwi & lemonade flavored beverage with added sugar for 3 weeks.

MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

干预措施: Strawberry Kiwi &Lemonade Flavored Beverage with added sugar (Dietary Supplement)

Beverage A (Unsweetened)

Active Comparator

One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks.

MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

干预措施: Black Cherry and Orange Flavored Beverage no added sugar (Dietary Supplement)

Beverage B (Unsweetened)

Active Comparator

One quarter of the group to receive strawberry kiwi & lemonade flavored beverage no added sugar for 3 weeks.

MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

干预措施: Strawberry Kiwi & Lemonade Flavored Beverage no added sugar (Dietary Supplement)

Beverage B (Unsweetened)

Active Comparator

One quarter of the group to receive strawberry kiwi & lemonade flavored beverage no added sugar for 3 weeks.

MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

干预措施: Water (Other)

Beverage A (Sweetened)

Active Comparator

One quarter of the group to receive black cherry and orange flavored beverage with added sugar for 3 weeks.

MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

干预措施: Water (Other)

Beverage A (Unsweetened)

Active Comparator

One quarter of the group to receive black cherry and orange flavored beverage no added sugar for 3 weeks.

MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

干预措施: Water (Other)

Beverage B (Sweetened)

Active Comparator

One quarter of the group to receive strawberry kiwi & lemonade flavored beverage with added sugar for 3 weeks.

MRIs will be performed before starting and then after 3 weeks of daily beverage consumption wherein participants will be presented with visual stimuli of two beverage logos, one representing a water solution and another representing the assigned beverage. Each 1-second presentation signals impending delivery of 3 mL of the associated beverage via a plastic mouthpiece during MRI.

干预措施: Water (Other)

结局指标

主要结局

Change in Voxel-wise Blood Oxygen Level Dependent (BOLD) Including Outliers Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Beverage Taste and Logo

时间窗: Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment

The fMRI paradigm assesses evoked blood oxygen level dependent (BOLD) response to receipt of study beverages (sweet and unsweet) and a water solution, and logo-elicited anticipation of both beverages and water solution. The visual stimuli are two beverage logos, a water logo, and a fixation cross. Each logo (1 second) signals impending delivery of 3 mL of the associated juice/water over 6 seconds, with the fixation cross otherwise presented. A jitter ranging from 5 to 13 seconds follows each trial. In total, the participants are shown 24 repeats of the events of interest over 4, 7-minute runs. Contrasts of interest are the post- \> pre-intervention BOLD response to sweetened beverage logo \> water logo. Parameter estimates for these contrasts are extracted and reported. A positive reported outcome reflects higher post- vs. pre-intervention (negative values reflect lower post- vs. pre-intervention) change in whole-brain BOLD response for sweetened beverage logo \> water logo for each arm.

次要结局

  • Change in Voxel-wise Blood Oxygen Level-Dependent (BOLD) Brain Activation in Response to Beverage Taste and Logo by Body Mass Index (BMI)(Baseline and Post-intervention Assessment. Post-Intervention Assessment completed approximately 5 weeks after the Baseline Assessment)
  • Beverage Perceptual Ratings Using Visual Analog Scales(Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment)
  • Stop Signal Reaction Time to Logo as Measured by Behavioral Response Inhibition Task(Pre-intervention Behavioral Assessment; Post-intervention Behavioral Assessment; Post-intervention Assessment completed approximately 5 weeks after the Pre-intervention Assessment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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