Ultra-processed Food-reducing Intervention and Continuous Glucose Monitoring

Официальное название

Effects of Ultra-processed Food Reduction Intervention on Postprandial Glucose and Glycemic Variability in Korean Young Adults: Study Protocol for the ULTRA-CGM Randomized Controlled Trial

Обзор

The goal of this trial is to investigate whether reduction in ultra-processed food intake through dietary counseling and education can improve postprandial glucose responses and glycemic variability compared with a usual diet in young, healthy Korean adults aged 20-30 years. The main questions it aims to answer are: \- Does reducing ultra-processed food intake, while maintaining total energy intake and usual lifestyle behaviors, improve postprandial glucose and lower glycemic variability in healthy adults without diabetes? Participants will: * Undergo the 10-day pre-intervention monitoring period, during which each participant will wear a continuous glucose monitoring (CGM) device and concurrently report their daily dietary intakes (all food and beverage consumption) and other lifestyle behaviors (sleep, smoking, physical activity) * After the 10-day pre-intervention monitoring period, participants will be randomized to either intervention or control group * Intervention group: Participants will visit the research site to receive dietitian-led one-on-one nutrition education and personalized dietary counseling targeting reduction of ultra-processed food intake. Personalized diet counseling will be provided by study dietitian based on participant's records of dietary intakes during the 10-day pre-intervention monitoring period. * Control group: Participants will receive dietitian-led nutrition education and personalized dietary counseling based on the national dietary guidelines. * After the intervention, participants will undergo the 10-day post-intervention monitoring period, during which participants will wear a new CGM device for an additional 10 days and continue daily reporting of dietary intakes (all food and beverage consumptions) and lifestyle behaviors (sleep, smoking, physical activity).

Подробное описание

The Ultra-Processed Food Reduction Intervention and Continuous Glucose Monitoring (ULTRA-CGM) trial is a parallel, two-arm randomized controlled trial designed to evaluate the effects of a ultra-processed food (UPF)-reducing dietary intervention on postprandial glucose responses and glycemic variability in young Korean adults (aged 20-39 years) using CGM devices. Participants will be randomly assigned to either a UPF-reducing intervention group or a control group maintaining their usual diet. We hypothesize that receiving the UPF-reducing dietary intervention will improve postprandial glucose responses and reduce glycemic variability compared with participants receiving standard dietary counseling based on national guidelines. The findings from this trial may provide experimental evidence on the metabolic effects of reducing UPF consumption and inform dietary strategies for diabetes prevention among younger adults.

Вмешательства

• Поведенческое 40-minute one-on-one dietary counseling and nutrition education aimed at reducing ultra-processed food consumption
  Participants assigned to the intervention group receive a 40-minute one-on-one nutrition education session and personalized dietary counseling delivered by the study dietitian. The goals of these sessions are to reduce UPF consumption while maintaining total energy intake and usual lifestyle behaviors. All sessions follow a standardized protocol to ensure consistent delivery of the intervention. The study dietitian delivering the intervention receives training on the standardized protocol prior
• Поведенческое Standard dietary counseling and nutrition education based on national guidelines
  Participants assigned to the control group are also provided with a 40-minute one-on-one nutrition education session and personalized dietary counseling, but with different objectives. During these sessions, the national dietary guidelines are introduced using an educational leaflet distributed by the Ministry of Health and Welfare. The education session and counseling provided to the control group do not include any information on UPFs. After completion of the study, participants in the control

Первичные конечные точки

• Change in postprandial glucose responses [Срок оценки: Change in mean values from the baseline monitoring period (10-day period before the intervention) to the post-intervention monitoring period (10-day period immediately following the intervention)]

Вторичные конечные точки (12)

• Change in coefficient of variation (CV) [Срок оценки: Change in mean values from the baseline monitoring period (10-day period before the intervention) to the post-intervention monitoring period (10-day period immediately following the intervention)]
• Change in standard deviation (mg/dL) [Срок оценки: Change in mean values from the baseline monitoring period (10-day period before the intervention) to the post-intervention monitoring period (10-day period immediately following the intervention)]
• Change in mean amplitude of glycemic excursions (MAGE) [Срок оценки: Change in mean values from the baseline monitoring period (10-day period before the intervention) to the post-intervention monitoring period (10-day period immediately following the intervention)]
• Change in glucose spike frequency [Срок оценки: Change in mean values from the baseline monitoring period (10-day period before the intervention) to the post-intervention monitoring period (10-day period immediately following the intervention)]
• Change in time-in-range (%) [Срок оценки: Change in mean values from the baseline monitoring period (10-day period before the intervention) to the post-intervention monitoring period (10-day period immediately following the intervention)]
• Change in time-in-tight-range (%) [Срок оценки: Change in mean values from the baseline monitoring period (10-day period before the intervention) to the post-intervention monitoring period (10-day period immediately following the intervention)]
• Change in time-above-range (%) [Срок оценки: Change in mean values from the baseline monitoring period (10-day period before the intervention) to the post-intervention monitoring period (10-day period immediately following the intervention)]
• Change in time-below-range (%) [Срок оценки: Change in mean values from the baseline monitoring period (10-day period before the intervention) to the post-intervention monitoring period (10-day period immediately following the intervention)]
• Change in body weight (kg) [Срок оценки: Change from study enrollment (day 1) to study completion (day 23; 10 days after the intervention)]
• Change in waist circumference (cm) [Срок оценки: Change from study enrollment (day 1) to study completion (day 23; 10 days after the intervention)]
• Change in fat mass (kg) [Срок оценки: Change from study enrollment (day 1) to study completion (day 23; 10 days after the intervention)]
• Change in muscle mass (kg) [Срок оценки: Change from study enrollment (day 1) to study completion (day 23; 10 days after the intervention)]

Критерии участия

Критерии включения

• Korean adults aged 20-39 years
• Not currently pregnant
• No personal history of diabetes or other glucose-related conditions
• Consume ≥25% of daily energy intake from UPFs, as assessed by an online, self-administered semi-quantitative screening food frequency questionnaire (FFQ)
• No restriction on wearing a CGM device
• No increased risk of bleeding
• No prior adverse reaction to CGM devices
• Willingness to participate in follow-up assessments

Критерии исключения

• Unable to maintain continuous follow-up during the study period (e.g., due to special plans such as traveling)
• Planning to follow a special or restrictive diet (e.g., for weight loss) during the study period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

South Korea · 1 центр

• Health Promotion Lab, College of Health Science, Korea University — Seoul

Публикации

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• Imai S, Fukui M, Ozasa N, Ozeki T, Kurokawa M, Komatsu T, Kajiyama S. Eating vegetables before carbohydrates improves postprandial glucose excursions. Diabet Med. 2013 Mar;30(3):370-2. doi: 10.1111/dme.12073. No abstract available. PMID 23167256
• O'Keefe JH, Bell DS. Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol. 2007 Sep 1;100(5):899-904. doi: 10.1016/j.amjcard.2007.03.107. Epub 2007 Jun 26. PMID 17719342
• Borg R, Kuenen JC, Carstensen B, Zheng H, Nathan DM, Heine RJ, Nerup J, Borch-Johnsen K, Witte DR; ADAG Study Group. Real-life glycaemic profiles in non-diabetic individuals with low fasting glucose and normal HbA1c: the A1C-Derived Average Glucose (ADAG) study. Diabetologia. 2010 Aug;53(8):1608-11. doi: 10.1007/s00125-010-1741-9. Epub 2010 Apr 16. PMID 20396998
• Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Fox LA, Beck RW, Xing D. Variation of interstitial glucose measurements assessed by continuous glucose monitors in healthy, nondiabetic individuals. Diabetes Care. 2010 Jun;33(6):1297-9. doi: 10.2337/dc09-1971. Epub 2010 Mar 9. PMID 20215454
• Shah VN, DuBose SN, Li Z, Beck RW, Peters AL, Weinstock RS, Kruger D, Tansey M, Sparling D, Woerner S, Vendrame F, Bergenstal R, Tamborlane WV, Watson SE, Sherr J. Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4356-4364. doi: 10.1210/jc.2018-02763. PMID 31127824
• Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Sab PMID 31177185
• Song J, Oh TJ, Song Y. Individual Postprandial Glycemic Responses to Meal Types by Different Carbohydrate Levels and Their Associations with Glycemic Variability Using Continuous Glucose Monitoring. Nutrients. 2023 Aug 13;15(16):3571. doi: 10.3390/nu15163571. PMID 37630761

Идентификаторы

NCT: NCT07175701 · KUIRB-2025-0600-05 · 2025-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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