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临床试验/NCT07808892
NCT07808892招募中不适用

Interactions Between Food Processing Level, Nutrition Quality, Nutrition Security and Anxiety in Israeli Adults: Influence on Dietary Intake

Ariel University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026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
招募中
入组人数
40
试验地点
1
主要终点
Total meal duration

研究概览

简要总结

The UPGRADE Study will examine how food-processing level and nutritional quality affect energy intake, eating rate, satiety, and glycemic response. In a randomized-order crossover design, each participant will consume three laboratory test meals: low processing/high nutritional quality, high processing/high nutritional quality, and high processing/low nutritional quality. Food intake and eating rate will be measured using a Universal Eating Monitor, alongside satiety, glycemic response, and energy intake during the remainder of the day.

The study will also explore whether anxiety and nutrition insecurity influence these responses. Comparisons between participants in Israel and the United States will assess whether background Mediterranean versus Western dietary patterns modify meal responses. The high-processing, low-nutritional-quality meal is expected to result in greater energy intake and eating rate, lower satiety, and a more pronounced glycemic response. Findings will inform future trials and dietary recommendations concerning ultra-processed foods and nutritional quality.

详细描述

The UPGRADE Study will examine how food-processing level and nutritional quality independently influence eating behavior, energy intake, satiety, and postprandial glycemic response. Using a randomized-order crossover design, each participant will consume three test meals under laboratory conditions: (1) low processing and high nutritional quality; (2) high processing and high nutritional quality; and (3) high processing and low nutritional quality. This design will enable planned comparisons of the effect of processing level when nutritional quality is held constant and the effect of nutritional quality when processing level is held constant.

Each meal will be served on a Universal Eating Monitor, which continuously records the amount and rate of food consumption. Additionally, meal time will be recorded during each meal to allow overall meal time calculation. Primary outcomes will include energy intake during the test meal, meal duration, eating rate, postprandial satiety, and glycemic response. Dietary intake during the remainder of the day will also be assessed to determine whether the test meals affect subsequent energy intake.

The study will further investigate whether anxiety and nutrition insecurity are associated with eating behavior and whether they modify responses to meals differing in processing level and nutritional quality. Participants with elevated anxiety are hypothesized to consume more energy during the laboratory meals and throughout the remainder of the day.

The study will be conducted in Israel, permitting exploratory comparisons between populations exposed to different background dietary patterns. The predominantly Mediterranean-oriented dietary pattern in Israel may influence participants' acute responses to the experimental meals.

It is hypothesized that the high-processing, low-nutritional-quality meal will produce the highest energy intake and eating rate, the lowest satiety, the greatest subsequent energy intake, and the most pronounced glycemic response. By distinguishing the effects of food processing from those of nutritional quality, this study will provide preliminary mechanistic evidence to inform future randomized controlled trials and dietary recommendations concerning ultra-processed foods, diet quality, and chronic disease risk.

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 (Outcomes Assessor)

盲法说明

Outcome assessors will be masked to meal condition and allocation sequence. Data from the Universal Eating Monitor, satiety questionnaires, glycemic measurements, and subsequent dietary intake assessments will be labeled using participant, visit, and neutral condition codes that do not reveal processing level or nutritional quality. The allocation key will be maintained separately by a study coordinator who is not involved in outcome assessment or data analysis. Assessors will process and verify outcomes using the coded dataset, and meal identities will be disclosed only after data cleaning and database lock. Staff preparing and serving the meals cannot be masked but will not participate in outcome assessment.

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • body mass index (BMI) 20-40 kg/m2

排除标准

  • pregnant nor lactating
  • people with food allergies of food intolerance

研究组 & 干预措施

Meal Sequence 1: LP-HNQ → HP-HNQ → HP-LNQ

Experimental

Participants will receive the low-processing/high-nutritional-quality meal in Period 1, the high-processing/high-nutritional-quality meal in Period 2, and the high-processing/low-nutritional-quality meal in Period 3. At each laboratory visit, food intake and eating rate will be recorded using the Universal Eating Monitor; satiety, postprandial glycemic response, and subsequent dietary intake will also be assessed.

干预措施: Test Meals Differing in Processing Level and Nutritional Quality (Other)

LP-HNQ → HP-LNQ → HP-HNQ

Experimental

Participants will receive the low-processing/high-nutritional-quality meal in Period 1, the high-processing/low-nutritional-quality meal in Period 2, and the high-processing/high-nutritional-quality meal in Period 3. At each laboratory visit, food intake and eating rate will be recorded using the Universal Eating Monitor; satiety, postprandial glycemic response, and subsequent dietary intake will also be assessed.

干预措施: Test Meals Differing in Processing Level and Nutritional Quality (Other)

HP-HNQ → LP-HNQ → HP-LNQ

Experimental

Participants will receive the high-processing/high-nutritional-quality meal in Period 1, the low-processing/high-nutritional-quality meal in Period 2, and the high-processing/low-nutritional-quality meal in Period 3. At each laboratory visit, food intake and eating rate will be recorded using the Universal Eating Monitor; satiety, postprandial glycemic response, and subsequent dietary intake will also be assessed.

干预措施: Test Meals Differing in Processing Level and Nutritional Quality (Other)

HP-HNQ → HP-LNQ → LP-HNQ

Experimental

Participants will receive the high-processing/high-nutritional-quality meal in Period 1, the high-processing/low-nutritional-quality meal in Period 2, and the low-processing/high-nutritional-quality meal in Period 3. At each laboratory visit, food intake and eating rate will be recorded using the Universal Eating Monitor; satiety, postprandial glycemic response, and subsequent dietary intake will also be assessed.

干预措施: Test Meals Differing in Processing Level and Nutritional Quality (Other)

HP-LNQ → LP-HNQ → HP-HNQ

Experimental

Participants will receive the high-processing/low-nutritional-quality meal in Period 1, the low-processing/high-nutritional-quality meal in Period 2, and the high-processing/high-nutritional-quality meal in Period 3. At each laboratory visit, food intake and eating rate will be recorded using the Universal Eating Monitor; satiety, postprandial glycemic response, and subsequent dietary intake will also be assessed.

干预措施: Test Meals Differing in Processing Level and Nutritional Quality (Other)

HP-LNQ → HP-HNQ → LP-HNQ

Experimental

Participants will receive the high-processing/low-nutritional-quality meal in Period 1, the high-processing/high-nutritional-quality meal in Period 2, and the low-processing/high-nutritional-quality meal in Period 3. At each laboratory visit, food intake and eating rate will be recorded using the Universal Eating Monitor; satiety, postprandial glycemic response, and subsequent dietary intake will also be assessed.

干预措施: Test Meals Differing in Processing Level and Nutritional Quality (Other)

结局指标

主要结局

Total meal duration

时间窗: During each test meal, from placement of the meal tray on the table until the participant indicates that they have finished eating and leaves the table (approximately 5-20 minutes; assessed once per test meal).

Total meal duration, expressed in minutes and seconds, will be determined from the video recording as the elapsed time between placement of the meal tray on the table and the participant indicating that they have finished eating and leaving the table.

Total energy intake in a test meal

时间窗: During each test meal (approximately 5-20 minutes; assessed once per test meal).

At each laboratory visit, participants will receive one of the test meals. Total energy intake (kcal) will be calculated by subtracting the post-meal weight from the pre-meal weight of each food item, multiplying the amount consumed (g) by the item's energy density (kcal/g), and summing the energy consumed across all meal items.

次要结局

  • Self-reported level of satiety(At each laboratory visit: immediately before the test meal, at meal termination, and 60 minutes after meal termination (assessment period of approximately 60-80 minutes).)
  • Blood glucose level(Measures will be taken at each lab visit at time 0 (prior to consuming the meal) and at times 30, 60 90 and 120 minutes after the meal.)
  • Height(Once at the first laboratory visit (baseline), between 8:00 and 10:00 a.m.; measurement takes approximately 5 minutes.)
  • Weight(Once at the first laboratory visit (baseline), between 8:00 and 10:00 a.m.; measurement takes approximately 5 minutes.)
  • Anxiety(Once at the first laboratory visit (baseline); the questionnaire assesses symptoms experienced during the preceding two weeks and takes approximately 2-5 minutes to complete.)
  • Household food insecurity risk(Once at the first laboratory visit (baseline); the questionnaire assesses experiences during the preceding 12 months and takes approximately 2-5 minutes to complete.)
  • Adherence to the Israeli Mediterranean diet pattern(At baseline, before the first test-meal session. The I-MEDAS assesses habitual current dietary intake using item-specific daily or weekly consumption frequencies; it does not employ one uniform retrospective recall period.)

研究者

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

Vered Kaufman Shriqui

Associate Professor, Department of Nutrition Sciences, Ariel University and Principal Investigator

Ariel University

研究点 (1)

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