NCT07808892

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Sep 2028

First Submitted

Initial submission to the registry

August 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

September 9, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 30, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

EnergyAnxietyFoodEatingNutrition

Outcome Measures

Primary Outcomes (2)

  • Total meal duration

    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.

    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 energy intake in a 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.

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

Secondary Outcomes (7)

  • 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.

  • +2 more secondary outcomes

Study Arms (6)

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.

Other: Test Meals Differing in Processing Level and Nutritional Quality

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.

Other: Test Meals Differing in Processing Level and Nutritional Quality

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.

Other: Test Meals Differing in Processing Level and Nutritional Quality

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.

Other: Test Meals Differing in Processing Level and Nutritional Quality

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.

Other: Test Meals Differing in Processing Level and Nutritional Quality

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.

Other: Test Meals Differing in Processing Level and Nutritional Quality

Interventions

Interventions: Three distinct meal interventions and six randomized sequence arms. The six arms differ only in intervention order. The meals are: LP-HNQ Meal: Low-processing, high-nutritional-quality test meal consumed under standardized laboratory conditions. HP-HNQ Meal: High-processing, high-nutritional-quality test meal consumed under standardized laboratory conditions. HP-LNQ Meal: High-processing, low-nutritional-quality test meal consumed under standardized laboratory conditions.

HP-HNQ → HP-LNQ → LP-HNQHP-HNQ → LP-HNQ → HP-LNQHP-LNQ → HP-HNQ → LP-HNQHP-LNQ → LP-HNQ → HP-HNQLP-HNQ → HP-LNQ → HP-HNQMeal Sequence 1: LP-HNQ → HP-HNQ → HP-LNQ

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • body mass index (BMI) 20-40 kg/m2

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ariel University

Ariel, 474000, Israel

RECRUITING

Related Publications (4)

  • Abu-Saad K, Endevelt R, Goldsmith R, Shimony T, Nitsan L, Shahar DR, Keinan-Boker L, Ziv A, Kalter-Leibovici O. Adaptation and predictive utility of a Mediterranean diet screener score. Clin Nutr. 2019 Dec;38(6):2928-2935. doi: 10.1016/j.clnu.2018.12.034. Epub 2019 Jan 5.

    PMID: 30642736BACKGROUND
  • Hager ER, Quigg AM, Black MM, Coleman SM, Heeren T, Rose-Jacobs R, Cook JT, Ettinger de Cuba SA, Casey PH, Chilton M, Cutts DB, Meyers AF, Frank DA. Development and validity of a 2-item screen to identify families at risk for food insecurity. Pediatrics. 2010 Jul;126(1):e26-32. doi: 10.1542/peds.2009-3146.

    PMID: 20595453BACKGROUND
  • Kaufman-Shriqui V, Navarro DA, Raz O, Boaz M. Dietary changes and anxiety during the coronavirus pandemic: a multinational survey. Eur J Clin Nutr. 2022 Jan;76(1):84-92. doi: 10.1038/s41430-021-00897-3. Epub 2021 Mar 19.

    PMID: 33742156BACKGROUND
  • Naval L, Lopez-Elzaurdia C, Monje F, Pastor V, Diaz F. [Neuroendocrine carcinoma of the skin or Merkel cell tumor. Apropos of a case]. Rev Stomatol Chir Maxillofac. 1988;89(5):311-5. French.

    PMID: 3064273BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Nutritive Value

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaFood QualityFood TechnologyFood IndustryIndustryTechnology, Industry, and AgriculturePublic HealthEnvironment and Public Health

Central Study Contacts

Vered Kaufman-Shriqui, PhD

CONTACT

Mona Boaz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Interventional Model: Crossover Assignment Allocation: Randomized Arm Type: Experimental for all six arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Nutrition Sciences, Ariel University and Principal Investigator

Study Record Dates

First Submitted

August 30, 2026

First Posted

September 9, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

September 9, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the informed consent and ethics approval did not include provisions for sharing participant-level data with external researchers. In addition, the relatively small study sample and the sensitive nature of the collected health and dietary information may create a risk of participant re-identification, even after de-identification. Study findings will be reported in aggregate form.

Locations