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NCT Number: NCT07808892

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

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ariel University

Ariel, 474000, Israel

Location status: Recruiting

Location contact

Mona Boaz, PhD

PRINCIPAL_INVESTIGATOR

Yael Tzur, MA

CONTACT

[email protected]

+972547766397

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • body mass index (BMI) 20-40 kg/m2

Exclusion criteria

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

Treatment and study plan

Test Meals Differing in Processing Level and Nutritional Quality

Other

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.

Primary outcomes

  1. 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).

    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.

  2. Total energy intake in a test meal

    Time frame: 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.

Secondary outcomes

  1. Self-reported level of satiety

    Time frame: 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).

    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.

  2. Blood glucose level

    Time frame: 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.

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

  3. Height

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

    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.

  4. Weight

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

    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.

  5. Anxiety

    Time frame: 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.

    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.

  6. Household food insecurity risk

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

    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).

  7. Adherence to the Israeli Mediterranean diet pattern

    Time frame: 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.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mona Boaz, PhD

CONTACT

[email protected]

+972502129666

Vered Kaufman-Shriqui, PhD

CONTACT

[email protected]

+972587751199

Sponsors and collaborators

Lead sponsor

Ariel University

Other

Registry information

Official study title

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

Acronym: UPGRADE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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