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临床试验/NCT05437809
NCT05437809招募中不适用

Biobehavioral Reward Responses Associated With Consumption of Nutritionally Diverse Ultra-Processed Foods

Oregon Research Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月20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
50
试验地点
1
主要终点
Consumption of UPFs and MPFs (EMA)

研究概览

简要总结

The changing food environment, with increasingly abundant ultra-processed food (UPF) options, may directly contribute to rising rates of obesity, though it is unknown which ingredients in UPF elevate their reinforcing nature in a way that may lead to overconsumption. The proposed study is the first to systematically examine differences in the rewarding characteristics of and physiological and metabolic responses to UPFs that are high in fat, refined carbohydrates (like sugar), or both. Understanding the biobehavioral underpinnings that enhance the reinforcing potential of ingredients in UPF (e.g., fat vs. refined carbohydrates) can inform novel intervention targets for the treatment of overeating and obesity.

详细描述

The abundance of ultra-processed foods (UPFs) in our environment has led to excessive calorie intake and been cited as perpetuating the obesity epidemic. UPFs do not exist in nature and are created to maximize palatability through the additions of fat, refined carbohydrates (RC), and/or sodium (e.g., chocolate, potato chips). Emerging research suggests UPFs may be reinforcing akin to rewarding substances like alcohol. However, empirical investigation of which ingredients in UPFs directly motivate overeating is in its nascent stages. This study will be the first to combine biological and behavioral methods used in addiction research with assessments of food reward, to delineate the mechanisms by which fat and RC drive UPF reinforcement and influence future consumption.

Individuals (n=50) with obesity will be recruited for the current study. Participants will attend four appointments (order randomized/counterbalanced) and will consume a snack consisting of 1) UPF high in fat + RC (UPF+FRC), 2) UPF high in fat (UPF+F), 3) UPF high in RC (UPF+RC), or 4) minimally processed foods (MPF). At each assessment, subjective experiences and metabolic responses will be assessed before and up to 120 minutes after consumption of each snack. An ad-libitum eating period for each food condition will follow to evaluate associations of metabolic/behavioral responses with subsequent intake. For five days after each appointment, participants will use ecological momentary assessment (EMA) to assess subjective experiences and real-world reported consumption of UPF+FRC, UPF+F, UPF+RC, and MPF.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women Age 18-65 years BMI ≥ 30 kg/m2 Endorse liking the foods included in the compulsory test snacks at a 6 on a scale from 1-10 No history of severe psychiatric illness; current mild to moderate severity of depression, anxiety, or binge eating disorder, determined by the behavioral evaluation and the screening measures will be included Live in the greater Springfield, Oregon area and are willing/able to participate in six in-person assessments Can access and are willing/able to use a smartphone

排除标准

  • Medical condition that may limit consumption of compulsory test snack foods or impact metabolic responses to food consumption Type I or II diabetes (HbA1c > 6.5 based on blood test) Uncontrolled hypertension (blood pressure ≥ 140/90 mm Hg) Cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months Individuals with dietary allergies of aversions to the test snack foods Individuals taking medications that may influence the metabolic responses of interest (e.g., metformin) Individuals who are actively pursuing weight loss or have lost ≥ 5% of their initial weight in the last 6 months Severe symptoms of mood, anxiety, and any severity of thought disorders Severe binge eating disorder or full criteria bulimia Persons with active substance-use disorders Current, active suicidal ideation, and/or a suicide attempt within the past year History of bariatric surgery Women who are nursing, pregnant, or planning to become pregnant in the next three months Self-report current diagnosis of a transferrable blood condition (including HIV, hepatitis B, hepatitis C, or syphilis) Self-report prior history of being dizzy or anxious during blood draws and/or technician not being able to find a vein.

研究组 & 干预措施

UPF high in fat and refined carbohydrates

Other

This test snack condition consists of ultra-processed foods high in both fat and refined carbohydrates.

干预措施: Intake of nutritionally diverse ultra-processed foods (Other)

UPF high in fat

Other

This test snack condition consists of ultra-processed foods high in fat.

干预措施: Intake of nutritionally diverse ultra-processed foods (Other)

UPF high in refined carbohydrates

Other

This test snack condition consists of ultra-processed foods high in refined carbohydrates.

干预措施: Intake of nutritionally diverse ultra-processed foods (Other)

MPF high in fat or carbohydrates

Other

This test snack condition consists of minimally processed foods naturally high in either fat or carbohydrates.

干预措施: Intake of nutritionally diverse ultra-processed foods (Other)

结局指标

主要结局

Consumption of UPFs and MPFs (EMA)

时间窗: EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)

Trained study staff will calculate the percentage of participants' daily calories from the four food categories (UPF+FRC, UPF+F, UPF+RC, MPF) based on participants' self-reported food consumption in EMA surveys.

Subjective reward responses to food intake (EMA)

时间窗: EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)

Indicators of subjective reward (craving, palatability, hedonic hunger, and mood) will be assessed by participants' self-reports in EMA surveys. Each facet of subjective reward will be assessed by 100-point visual analog scales ranging from 0-100.

Subjective reward responses to food intake (in lab)

时间窗: 10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.

Indicators of subjective reward (craving, palatability, hedonic hunger, and mood) will be assessed by participants' self-reports before, during, and after consumption of the test snack at each of the four food consumption appointments. Each facet of subjective reward will be assessed by 100-point visual analog scales ranging from 0-100.

Ad libitum consumption

时间窗: 2 hours after test snack intake at each food consumption assessment.

Total number of calories consumed from the test snack food during a 15-minute eating period. Calories will calculated by measuring bowls containing the test snacks before and after participant consumption on a digital scale accurate to 0.01 grams. The difference in grams will be converted into the calories that the participant ate.

Daily calorie intake (EMA)

时间窗: EMA surveys administered over 5 days following each food consumption assessment (20 total days of EMA data)

Calorie intake will be derived from participants' self-reported food consumption in EMA surveys.

次要结局

  • Magnitude of metabolic responses to food intake(10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.)
  • Changes in heart rate in response to food intake(10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.)
  • Salivation responses to food intake(10 minutes before intake of test snack, during, and 30-, 60-, 90-, and 120 minutes after intake of the test snack.)

研究者

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

elafata@ori.org

Research Scientist

Oregon Research Institute

研究点 (1)

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