Ultra-Processing and Nutritional Quality: Glycemic Response, Appetite, Dietary Energy Intake, and Eating Rate (UPGRADE)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Vered Kaufman-Shriqui, PhD
- 電話番号：+972587751199
- メール：veredks@ariel.ac.il
研究連絡先のバックアップ
- 名前：Mona Boaz, PhD
- 電話番号：+972502129666
- メール：monabo@ariel.ac.il
研究場所
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Ariel、イスラエル、474000
- 募集
- Ariel University
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コンタクト：
- Yael Tzur, MA
- 電話番号：+972547766397
- メール：yaeltz@ariel.ac.il
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主任研究者：
- Mona Boaz, PhD
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- body mass index (BMI) 20-40 kg/m2
Exclusion Criteria:
- pregnant nor lactating
- people with food allergies of food intolerance
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Meal Sequence 1: LP-HNQ → HP-HNQ → HP-LNQ
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.
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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. |
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実験的：LP-HNQ → HP-LNQ → HP-HNQ
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.
|
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. |
|
実験的：HP-HNQ → LP-HNQ → HP-LNQ
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.
|
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. |
|
実験的：HP-HNQ → HP-LNQ → LP-HNQ
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.
|
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. |
|
実験的：HP-LNQ → LP-HNQ → HP-HNQ
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.
|
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. |
|
実験的：HP-LNQ → HP-HNQ → LP-HNQ
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.
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total meal duration
時間枠：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).
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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.
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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).
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Total energy intake in a test meal
時間枠：During each test meal (approximately 5-20 minutes; assessed once per test meal).
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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.
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During each test meal (approximately 5-20 minutes; assessed once per test meal).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-reported level of satiety
時間枠：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).
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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.
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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).
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Blood glucose level
時間枠：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.
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Blood glucose levels will be measured by capillary fingerstick using a safety lancet, tested with a glucometer (Freestyle Optium Neo (Abbot ©).
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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.
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Height
時間枠：Once at the first laboratory visit (baseline), between 8:00 and 10:00 a.m.; measurement takes approximately 5 minutes.
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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.
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Once at the first laboratory visit (baseline), between 8:00 and 10:00 a.m.; measurement takes approximately 5 minutes.
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Weight
時間枠：Once at the first laboratory visit (baseline), between 8:00 and 10:00 a.m.; measurement takes approximately 5 minutes.
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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.
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Once at the first laboratory visit (baseline), between 8:00 and 10:00 a.m.; measurement takes approximately 5 minutes.
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Anxiety
時間枠：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.
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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.
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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.
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Household food insecurity risk
時間枠：Once at the first laboratory visit (baseline); the questionnaire assesses experiences during the preceding 12 months and takes approximately 2-5 minutes to complete.
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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).
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Once at the first laboratory visit (baseline); the questionnaire assesses experiences during the preceding 12 months and takes approximately 2-5 minutes to complete.
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Adherence to the Israeli Mediterranean diet pattern
時間枠：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.
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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).
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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.
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AU-HEA-MB-20241216
- NM-8614-24M (その他の助成金/資金番号：BARD- The Unites States-Israel Binational Agricultural Research and Development Fund)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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