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临床试验/NCT05200845
NCT05200845已完成不适用

The Role of Altered Nutrient Partitioning in Food Reward

Virginia Polytechnic Institute and State University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in Preference- Liking

研究概览

简要总结

Obesity remains a public health epidemic despite substantial advances in treatment strategies and therapies in the last decade. Effective strategies to support maintenance of improved metabolic health and reduced body weight are still needed.

Signals from the gut to the brain are important in regulating metabolism and energy balance and have been linked with food reward and preference in metabolically healthy individuals with normal body mass index. In particular, post-ingestive signaling related to glucose metabolism has been linked with food reward and preference. However, not much is known about how these gut and brain signals interact to influence eating behaviors in states of obesity or altered metabolic health. In addition, evidence in rodent models and human studies indicates obesity is associated with a blunted brain response to foods compared with normal body weight. However, whether altered nutrient utilization, termed metabolic inflexibility, influences the relationship between obesity and food reward has yet to be studied.

The overall objective of this proof-of-concept pilot study is to assess the feasibility of measuring reward response following a flavor-nutrient conditioning paradigm across the normal to obese body mass index (BMI) range and in states of altered metabolic health. The aims of this study are: 1) to determine whether differences in reinforcement learning/flavor-nutrient conditioning of carbohydrate can be measured across the body mass index range; and 2) to determine the feasibility of assessing metabolic flexibility and whether a relationship between metabolic flexibility and calorie-predictive reward can be detected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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

入选标准

  • BMI between 18.5-40 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
  • Specific to fMRI scan only: BMI between 25-35 kg/m2

排除标准

  • Current inhaled nicotine use
  • History of alcohol dependence.
  • Current or past diagnosis of diabetes or thyroid problems.
  • Glycated hemoglobin (Hemoglobin A1C) >5.7%
  • Taking medications known to influence study measures (including antiglycemic agents, thyroid medications, sleep medications)
  • Active medical or neurologic disorder.
  • Recent change in body weight (gain or loss of > 5 lbs within the past 3 months)
  • 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. (Note: This is an fMRI-specific exclusion criterion. Participants may be allowed to participate in all other study sessions and measures that do not involve fMRI.)
  • Contraindications for bioelectrical impedance analysis, specifically implanted devices

结局指标

主要结局

Change in Preference- Liking

时间窗: Baseline and at 4 weeks

Subjective ratings of liking of flavors used in the intervention were 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

  • Post-test Preference - Wanting(Baseline and at 4 weeks)
  • Substrate Oxidation Response to Test Meals(6-hour measurement)
  • Energy Expenditure in Response to Beverages(1.5-hour measurement)
  • Respiratory Exchange Ratio in Response to Beverages(1.5-hour measurement)
  • Substrate Oxidation in Response to Beverages(1.5-hour measurement)
  • Post-test Preference - Wanting(Baseline and at 4 weeks)
  • Substrate Oxidation Response to Test Meals(6-hour measurement)
  • Energy Expenditure in Response to Beverages(1.5-hour measurement)
  • Respiratory Exchange Ratio in Response to Beverages(1.5-hour measurement)
  • Substrate Oxidation in Response to Beverages(1.5-hour measurement)
  • Change in Preference- Wanting(5-minute measurement)
  • Blood Oxygen Level-dependent (BOLD) Response to Beverages(30-minute measurement that occurs during the post-test, approximately 4 weeks after the first study session)
  • Blood Insulin Response to Beverages(2-hour measurement)
  • Blood Glucose Response to Beverages(2-hour measurement)

研究者

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

Alexandra DiFeliceantonio

Assistant Professor

Virginia Polytechnic Institute and State University

研究点 (2)

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