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临床试验/NCT06015490
NCT06015490已完成不适用

The Impact of the Physiological Response to Sugar on Brain Activity and Behavior

Virginia Polytechnic Institute and State University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2023年9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
已完成
入组人数
7
试验地点
1
主要终点
Change in Preference- Subjective Liking Ratings for Each Beverage on a Scale

研究概览

简要总结

The goal of this pilot study is to test the feasibility of assessing how biological factors and chemical properties of sugars may influence metabolism and food reward in humans. The main questions it aims to answer are:

• Can differences in appetitive responses and neural activations to sucrose (table sugar) and its chemical components (glucose and fructose) be measured and quantified?

This study is a crossover design, meaning every participant will complete every condition. Participants will consume beverages containing sucrose, glucose, or fructose, which are each novelly flavored, 6 times within a week. During one of the consumption times, energy expenditure, carbohydrate oxidation, and blood glucose will be measured in the lab before and for 2 hours after consumption. After participants have consumed each condition, they will undergo a tasting task in the MRI scanner, neural responses to receipt of the beverages are measured.

详细描述

Prior studies in humans indicate that while energy expenditure response is similar after consumption of equal amounts of fructose, glucose, and sucrose (a dimer of glucose + fructose), carbohydrate oxidation and blood glucose responses differ. Elevated carbohydrate oxidation responses appear to be driven by the presence of fructose, and elevated blood glucose responses appear to be driven by the presence of glucose. Prior work also suggests that post-ingestive signals of glucose availability, measure specifically as blood glucose levels, intestinal glucose transporter activity, and carbohydrate oxidation rate, are all associated with elevated brain response to calorie-predictive flavor cues and reward learning of these flavor cues. However, in animal models, glucose has been shown to repeatedly and reliably condition these calorie-predictive learning responses, but fructose does not. Human work has indicated that oxidation of glucose is critical for these responses. Thus, it is unclear what roles fructose and glucose each play in conditioning reward responses and flavor-calorie learning. We hypothesize that fructose plays a synergistic role in enhancing flavor-calorie learning without itself conditioning the reward response.

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 18.5-25 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 (FBRI) at Virginia Tech Carilion
  • •Weigh at least 110 lbs

排除标准

  • •Current inhaled nicotine use
  • •History of alcohol dependence.
  • •Current or past diagnosis of cardiometabolic disease or problems, including diabetes, endocrine, heart, or thyroid problems, that may influence study outcomes
  • •Hemoglobin A1C >5.7%
  • •Taking medications known to influence study measures (including attention-deficit/hyperactivity disorder (ADHD), allergy, antidepressant, antipsychotic, anxiolytic, birth control, blood pressure, blood glucose, cholesterol, thyroid, sleep, or weight loss medications)
  • •Active medical or neurologic disorder, including cardiometabolic conditions or gastrointestinal conditions that may influence study outcomes
  • •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
  • •Use of substances (or combinations of substances) in doses and frequencies that could influence neural outcomes of study.

研究组 & 干预措施

Sucrose, then Glucose, then Fructose

Experimental

Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.

干预措施: Sucrose drink (Other)

Sucrose, then Glucose, then Fructose

Experimental

Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.

干预措施: Glucose drink (Other)

Sucrose, then Glucose, then Fructose

Experimental

Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.

干预措施: Fructose drink (Other)

Sucrose, then Fructose, then Glucose

Experimental

Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.

干预措施: Sucrose drink (Other)

Sucrose, then Fructose, then Glucose

Experimental

Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.

干预措施: Glucose drink (Other)

Sucrose, then Fructose, then Glucose

Experimental

Participants will consume a 110 kcal sucrose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.

干预措施: Fructose drink (Other)

Glucose, then Fructose, then Sucrose

Experimental

Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.

干预措施: Sucrose drink (Other)

Glucose, then Fructose, then Sucrose

Experimental

Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.

干预措施: Glucose drink (Other)

Glucose, then Fructose, then Sucrose

Experimental

Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal fructose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.

干预措施: Fructose drink (Other)

Glucose, then Sucrose, then Fructose

Experimental

Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.

干预措施: Sucrose drink (Other)

Glucose, then Sucrose, then Fructose

Experimental

Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.

干预措施: Glucose drink (Other)

Glucose, then Sucrose, then Fructose

Experimental

Participants will consume a 110 kcal glucose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal fructose drink 6 times during 1 week.

干预措施: Fructose drink (Other)

Fructose, then Glucose, then Sucrose

Experimental

Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.

干预措施: Sucrose drink (Other)

Fructose, then Glucose, then Sucrose

Experimental

Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.

干预措施: Glucose drink (Other)

Fructose, then Glucose, then Sucrose

Experimental

Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal glucose drink 6 times during 1 week, and then, a 110 kcal sucrose drink 6 times during 1 week.

干预措施: Fructose drink (Other)

Fructose, then Sucrose, then Glucose

Experimental

Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.

干预措施: Sucrose drink (Other)

Fructose, then Sucrose, then Glucose

Experimental

Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.

干预措施: Glucose drink (Other)

Fructose, then Sucrose, then Glucose

Experimental

Participants will consume a 110 kcal fructose drink 6 times during 1 week. Then, they will consume a 110 kcal sucrose drink 6 times during 1 week, and then, a 110 kcal glucose drink 6 times during 1 week.

干预措施: Fructose drink (Other)

结局指标

主要结局

Change in Preference- Subjective Liking Ratings for Each Beverage on a Scale

时间窗: Immediately after informed consent and in the post-test session approximately 5 weeks later

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.

Change in Preference- Subjective Liking Ratings for Each Beverage on a Scale

时间窗: Immediately after informed consent and in the post-test session approximately 5 weeks later

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

  • Post-Test Measure of Preference- Subjective Wanting Ratings for Each Beverage on a Scale(At the end of study; approximately 5 weeks after first session)
  • Post-Test Measure of Preference - Wanting (ad Libitum Intake): The Amount Consumed of Each Beverage is Reported as the Outcome(At the end of study; approximately 5 weeks after first session)
  • Post-Test Measure of Preference- Subjective Wanting Ratings for Each Beverage on a Scale(At the end of study; approximately 5 weeks after first session)
  • Post-Test Measure of Preference - Wanting (ad Libitum Intake): The Amount Consumed of Each Beverage is Reported as the Outcome(At the end of study; approximately 5 weeks after first session)
  • Post-Test Measure of Preference- Wanting (Forced Choice): Number of Participants Who Chose Each Indicated Beverage(At the end of study; approximately 5 weeks after first session)
  • Blood Oxygen Level-dependent (BOLD) Response to Beverages(At the end of study; approximately 5 weeks after first session)
  • 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)

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 (1)

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