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临床试验/NCT06053294
NCT06053294招募中不适用

Neural and Metabolic Factors in Carbohydrate Reward: An Examination of Speed

Virginia Polytechnic Institute and State University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
Change in preference- liking

研究概览

简要总结

Dietary factors contributed to nearly 50% of all cardiometabolic deaths in the US in 2012, making it one of the leading causes of preventable death in the US, second only to tobacco use. Human diets and food choices can't help but be influenced by the ubiquitous availability of processed foods of high-energy density and low nutrient content, consumption of which can lead to obesity, type II diabetes, heart disease, and other types of metabolic dysfunction. Surprisingly, food reinforcement does not rely on perceived energy density. Rather food reinforcement is associated with actual energy density and therefore, on an implicit knowledge of caloric content. That implicit knowledge must have a neural signature and a mechanism by which the gut communicates nutritive value to the brain. There is evidence, at least for fat and carbohydrates, that these pathways are separable, but terminate in a common neural structure, the dorsal striatum or caudate. This could be one mechanism by which modern processed foods high in both fat and carbohydrate are so sought after and readily consumed, In fact, when experimentally tested, fat and carbohydrate combinations were more reinforcing calorie for calorie than fat or carbohydrates alone and the level of reinforcement correlated with activity in reward- related brain areas. Beyond simple reinforcing value, it is known from the literature on drugs of abuse that the faster a drug is arrives at the brain, the higher it's abuse potential, however, little is known about how the kinetics of nutrient excursion influence food preference, choice, and brain activity. This project aims to test this specifically for carbohydrate reward.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •BMI between 18.5-30 kg/m2
  • •Not pregnant or planning to become pregnant during study participation
  • •Residing in the Roanoke area and/or willing/able to attend sessions at the Fralin Biomedical Research Institute
  • •Able to speak and write in English

排除标准

  • •Current inhaled nicotine use
  • •History of alcohol dependence.
  • •Current or past diagnosis of diabetes or thyroid problems.
  • •Taking medications known to influence study measures (including antiglycemic agents, thyroid medications, sleep medications)
  • •Active medical or neurologic disorder.
  • •Current shift work (typical pattern of work/activity overnight)
  • •Previous weight loss surgery
  • •Adherence to a special diet within the past 3 months (e.g., low-carb or ketogenic diet, exclusion of food groups/specific macronutrients, intermittent fasting, etc.)
  • •Allergy to any food or ingredient included in the study diets, meals, or beverages
  • •Currently pregnant or planning to become pregnant during study participation
  • •Claustrophobia
  • •Contraindications for MRI, including pacemaker, aneurysm clips, neurostimulators, cochlear or other implants, metal in eyes, regular work with steel, etc.

研究组 & 干预措施

CS+Slow First

Experimental

Participants who receive the CS+Slow First

干预措施: CS- Beverage (Other)

CS- First

Experimental

Participants who receive the conditional stimulus (CS) - first.

干预措施: CS+Fast (Other)

CS- First

Experimental

Participants who receive the conditional stimulus (CS) - first.

干预措施: CS+Slow (Other)

CS+Fast First

Experimental

Participants who receive the CS+Fast First

干预措施: CS- Beverage (Other)

CS+Fast First

Experimental

Participants who receive the CS+Fast First

干预措施: CS+Fast (Other)

CS+Fast First

Experimental

Participants who receive the CS+Fast First

干预措施: CS+Slow (Other)

CS+Slow First

Experimental

Participants who receive the CS+Slow First

干预措施: CS+Fast (Other)

CS+Slow First

Experimental

Participants who receive the CS+Slow First

干预措施: CS+Slow (Other)

CS- First

Experimental

Participants who receive the conditional stimulus (CS) - first.

干预措施: CS- Beverage (Other)

结局指标

主要结局

Change in preference- liking

时间窗: at the end of the study; 5 weeks after start of study

Subjective ratings of liking of flavors used in the intervention will be assessed at baseline and after the intervention. The generalized Labeled Magnitude Scale will be used. The scale is anchored by descriptors of "Most Disliked Sensation Imaginable" and "Most Liked Sensation Imaginable" at the lower and upper ends, respectively. The score is determined by the place on the scale participants select (range of scale is 0-100). An increase in score from baseline to post-intervention indicates an increase in liking.

次要结局

  • Blood insulin response to beverages(Each week for 3 weeks during the study)
  • Change in preference- wanting, rated(at the end of the study; 5 weeks after start of study)
  • Change in preference- wanting, ad lib intake(at the end of the study; 5 weeks after start of study)
  • Blood glucose response to beverages(Each week for 3 weeks during the study)
  • Energy expenditure in response to beverages(Each week for 3 weeks during the study)
  • Respiratory exchange ratio in response to beverages(Each week for 3 weeks during the study)
  • Change in preference- wanting, forced choice(at the end of the study; 5 weeks after start of study)
  • Blood oxygen level-dependent (BOLD) response to beverages(at the end of the study; 5 weeks after start of study)
  • Substrate oxidation in response to beverages(Each week for 3 weeks during the study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra DiFeliceantonio

Assitant Professor

Virginia Polytechnic Institute and State University

研究点 (1)

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