Ultra-Processing and Nutritional Quality: Glycemic Response, Appetite, Dietary Energy Intake, and Eating Rate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorAriel University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
body mass index (BMI) 20-40 kg/m2
Disqualifiers
pregnant nor lactating
people with food allergies of food intolerance
Trial design
Design model
Crossover
Treatments tested in this trial
Test Meals Differing in Processing Level and Nutritional Quality
Other interventionInterventions: 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.
Treatment groups
40 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Meal Sequence 1: LP-HNQ → HP-HNQ → HP-LNQExperimental treatment 1 intervention
Group B: LP-HNQ → HP-LNQ → HP-HNQExperimental treatment 1 intervention
Group C: HP-HNQ → LP-HNQ → HP-LNQExperimental treatment 1 intervention
Group D: HP-HNQ → HP-LNQ → LP-HNQExperimental treatment 1 intervention
Group E: HP-LNQ → LP-HNQ → HP-HNQExperimental treatment 1 intervention
Group F: HP-LNQ → HP-HNQ → LP-HNQExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
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).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.
Time frame
During each test meal (approximately 5-20 minutes; assessed once per test meal).Secondary outcomes
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.
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).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 ©).
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.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.
Time frame
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.
Time frame
Once at the first laboratory visit (baseline), between 8:00 and 10:00 a.m.; measurement takes approximately 5 minutes.Sponsors and contacts
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Source ClinicalTrials.gov