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EatingUPGRADENCT07808892

Ultra-Processing and Nutritional Quality: Glycemic Response, Appetite, Dietary Energy Intake, and Eating Rate

A study testing Test Meals Differing in Processing Level and Nutritional Quality in people with Eating and Anxiety, run by Ariel University at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Eating, Anxiety, Ultra Processed Food
What is being tested?
Test Meals Differing in Processing Level and Nutritional Quality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIsrael
Study dates
1 Sep 2026to 1 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • body mass index (BMI) 20-40 kg/m2

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vered Kaufman-Shriqui, PhD contact

+972587751199

veredks@ariel.ac.il

Mona Boaz, PhD contact

+972502129666

monabo@ariel.ac.il

Israel1 site, 1 recruiting
  • Ariel University

    Ariel, 474000

    Yael Tzur, MA, +972547766397, yaeltz@ariel.ac.il

    Mona Boaz, PhD

    Recruiting

Other trials in Israel

About this study

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

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.

Read the detailed description

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.

Being tested
Test Meals Differing in Processing Level and Nutritional Quality
Keywords
Energy, Anxiety, Food, Eating, Nutrition
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test Meals Differing in Processing Level and Nutritional QualityOther

    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.

Study groups in NCT07808892
Study groupRoleWhat they receive
Meal Sequence 1: LP-HNQ → HP-HNQ → HP-LNQExperimentalParticipants 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.
Receives: Other: Test Meals Differing in Processing Level and Nutritional Quality
LP-HNQ → HP-LNQ → HP-HNQExperimentalParticipants 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.
Receives: Other: Test Meals Differing in Processing Level and Nutritional Quality
HP-HNQ → LP-HNQ → HP-LNQExperimentalParticipants 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.
Receives: Other: Test Meals Differing in Processing Level and Nutritional Quality
HP-HNQ → HP-LNQ → LP-HNQExperimentalParticipants 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.
Receives: Other: Test Meals Differing in Processing Level and Nutritional Quality
HP-LNQ → LP-HNQ → HP-HNQExperimentalParticipants 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.
Receives: Other: Test Meals Differing in Processing Level and Nutritional Quality
HP-LNQ → HP-HNQ → LP-HNQExperimentalParticipants 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.
Receives: Other: Test Meals Differing in Processing Level and Nutritional Quality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. 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.

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

Secondary outcomes (7)
  1. Self-reported level of satiety

    Satiety will be assessed using a 10-point numerical visual analogue scale ranging from 1 ("not full at all") to 10 ("extremely full"). Higher scores indicate greater perceived satiety.

    Measured: 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).

  2. Blood glucose level

    Blood glucose levels will be measured by capillary fingerstick using a safety lancet, tested with a glucometer (Freestyle Optium Neo (Abbot ©).

    Measured: 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.

  3. Height

    Standing height will be measured without shoes, to the nearest 0.1 cm, using a calibrated wall-mounted stadiometer. Participants will stand upright with their head positioned in the Frankfort horizontal plane. Two measurements will be obtained, and their mean will be used in the analysis. If the two measurements differ by more than 0.5 cm, a third measurement will be obtained.

    Measured: Once at the first laboratory visit (baseline), between 8:00 and 10:00 a.m.; measurement takes approximately 5 minutes.

  4. Weight

    Body weight will be measured without shoes and while wearing light clothing, to the nearest 0.1 kg, using the InBody 770 body-composition analyzer. Participants will stand upright and remain still during the measurement.

    Measured: Once at the first laboratory visit (baseline), between 8:00 and 10:00 a.m.; measurement takes approximately 5 minutes.

  5. Anxiety

    Anxiety will be measured using the Hebrew Generalized Anxiety Disorder (GAD)-7 scale (Löwe, Decker \& Müller et al, 2008). Participants rate how frequently they experienced each symptom during the preceding two weeks on a scale from 0 ("not at all") to 3 ("nearly every day"). Item scores are summed to produce a total score ranging from 0 to 21, with higher scores indicating greater anxiety symptom severity. Scores of 5, 10, and 15 represent thresholds for mild, moderate, and severe anxiety symptoms, respectively.

    Measured: 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.

  6. Household food insecurity risk

    Household food insecurity risk will be assessed using the Hunger Vital Sign™, a validated two-item screening tool derived from the U.S. Household Food Security Survey Module. Participants will report whether each statement was "often true," "sometimes true," or "never true" during the preceding 12 months. A positive screen-indicating risk of household food insecurity-will be defined as a response of "often true" or "sometimes true" to either or both items. Participants responding "never true" to both items will be classified as not at risk (Hager et al., 2010).

    Measured: Once at the first laboratory visit (baseline); the questionnaire assesses experiences during the preceding 12 months and takes approximately 2-5 minutes to complete.

  7. Adherence to the Israeli Mediterranean diet pattern

    Adherence will be assessed using the 17-item Israel Mediterranean Diet Adherence Screener (I-MEDAS), adapted to reflect the Israeli Mediterranean dietary pattern and national dietary recommendations. Each item is scored 0 or 1 according to whether the specified dietary criterion is met. Scores are summed to produce a total score ranging from 0 to 17, with higher scores indicating greater adherence to the Mediterranean dietary pattern (Abu-Saad et al., 2019).

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Interventional Model: Crossover Assignment Allocation: Randomized Arm Type: Experimental for all six arms
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07808892
Sponsor's protocol ID
AU-HEA-MB-20241216
Other IDs
NM-8614-24M
Acronym
UPGRADE
Status last verified
Aug 2026
First submitted
30 Aug 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 30642736
  • 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.

    PubMed 20595453
  • 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.

    PubMed 33742156
  • 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.

    PubMed 3064273

Questions about this trial

What is this clinical trial studying?

A study testing Test Meals Differing in Processing Level and Nutritional Quality in people with Eating and Anxiety, run by Ariel University at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vered Kaufman-Shriqui, PhD (+972587751199, veredks@ariel.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total meal duration (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07808892, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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