Ultra-processed Food Reducing Intervention and Continuous Glucose Monitoring
NCT ID: NCT07175701
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-10-01
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Does the reduction in ultra-processed food intake lower postprandial glucose levels and glycemic variability in healthy adults without a history of diabetes?
* Does the reduced intake in different ultra-processed food subgroups and items differentially influence postprandial glucose and glycemic variability?
* Does other dietary and lifestyle factors (physical activity, sleep, smoking) alter the association between ultra-processed food intake reduction and glycemic variability?
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 consumptions) 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 nutrition education and personalized diet counseling targeting reduction of ultra-processed food intake, as well as improving diet quality. 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 diet counseling targeting general improvement in nutrient intake (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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Daily Eating Duration on Health
NCT05964179
Glycemic Index/Saturated Fatty Acid Diet and Hepatic Fat
NCT04054297
Dietary Interventions in Prediabetes
NCT01729078
Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity
NCT03189121
Glycemic Index, Body Weight and Health
NCT00324090
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
According to the Nova classification, UPFs represents the most highly processed category of foods, including items such as sugar-sweetened beverages, packaged snacks, fast foods, and instant noodles. UPFs are typically characterized by poor nutritional quality (e.g., high in energy density, dietary fat, and sodium; low in dietary fiber and essential micronutrients) along with the use of ingredients not commonly used in household cooking, such as artificial flavorings, emulsifiers, and colorants. Excessive energy intake and nutrient imbalance resulting from UPF intake have been associated with an increased risk of obesity and chronic diseases, including diabetes. However, food additives commonly found in UPFs may also contribute to chronic inflammation, insulin resistance, and gut microbiome imbalances, all of which can promote glycemic dysregulation leading to the development of type 2 diabetes, independently of their nutrient quality. However, some UPFs with modified nutrient profiles, such as reduced saturated fat or added artificial sweeteners, are often considered as 'healthy' under the current nutrient-based dietary guidelines despite their high food additive contents. In Korea, from 1998 to 2018, the contribution of UPFs to total energy intake continuously increased, whereas that of minimally processed foods declined. Despite the increasing trend of UPF intake, evidence from randomized controlled trials (RCT) directly examining its association with glycemic outcomes including postprandial glucose level and glycemic variability remains limited. As dietary and lifestyle factors may act as potential confounders, RCTs are needed to establish a causal relationship.
Additionally, a previous meta-analysis showed that the magnitude of the associations with type 2 diabetes varied across different UPF subgroups, with processed meats and artificially- and sugar-sweetened beverages showing the greatest magnitude of positive associations. The findings of the previous study suggest that not all UPFs are equally harmful and address the limitations of current Nova classification. While the Nova classification provides a useful framework for identifying UPFs based on the methods and degrees of processing, it does not fully capture the heterogeneity within the group, such as differences in nutrient profiles, amount and types of additives, and specific processing techniques.
Continuous glucose monitoring (CGM) devices provide more accurate and real-time glycemic assessment. This study aims to investigate whether reduction in UPF intake can improve postprandial glucose levels (measured 2 hours after meal initiation) and glycemic variability (coefficient of variation \[CV\], standard deviation \[SD\], time in range 70-180 mg/dL \[TIR70-180\], time in range 90-126 mg/dL \[TIR90-126\], time above range \>126 mg/dL \[TAR126\], and time below range \<90 mg/dL \[TBR90\], in healthy adults aged 20-30 years. Glycemic responses under free-living conditions will be assessed using CGM, allowing for detailed observation of glucose fluctuations in response to daily dietary intake. In addition, this study aims to evaluate the potential role of lifestyle behaviors including sleep, smoking, and physical activity as effect modifiers in the association between reduction in UPF intake and glycemic outcomes.
This study is a single-site, individually randomized trial conducted in Seoul, Korea, by the Health Promotion and Chronic Disease Epidemiology Lab at the College of Health Science, Korea University (KU). The study protocol was designed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. In summary, 40 adults aged 20-30 years, with no personal history of diabetes and whose energy intake from UPFs constitutes 25% or more, will be recruited from the community. Participants will be observed for 10 days to assess baseline (pre-intervention) glucose levels, dietary intake and lifestyle. To ensure rigorous glucose monitoring, all participants will be wearing a CGM device. This will be followed by a dietary education and counselling session. Participants assigned in the control group will receive conventional dietary education based on nutrient-based national dietary guidelines, whereas those in the intervention group will receive education aimed at reducing UPF intake. After the education and counselling sessions, all participants will be observed for an additional 10 days to collect CGM-derived glucose data, dietary intake, and lifestyle in order to evaluate changes compared to the baseline period.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
Participants will be randomly assigned to the intervention group using block randomization with a 1:1 allocation ratio.
Behavioral: Nutritional education and diet counselling
All participants will be asked to visit the study site after the 10-day baseline monitoring period. They will receive a 30-minute nutrition education focusing on reducing UPF intake; and personalized counselling session based on their dietary intake observed during the baseline monitoring period.
Participants allocated to the intervention group will receive nutrition education and personalized counselling aimed at reducing ultra-processed food (UPF) intake by encouraging the substitution of UPFs with unprocessed/minimally processed foods, thereby improving overall diet quality. Participants will be educated on the definition of UPFs, how to identify them, practical strategies for reducing UPF intake, UPF-reducing recipes, and the associations between UPF intake and health outcomes. The content related to UPFs was developed based on previous studies exploring the health effects of UPF intake, while the content on diet quality was based on the 2020 Korean Dietary Reference Intakes.
Control group
Participants will be randomly assigned to the control group using block randomization with a 1:1 allocation ratio.
Conventional nutrition education and diet counseling
All participants will be asked to visit the study site after the 10-day baseline monitoring period. Participants in the control group will receive a conventional nutrient-based education and personalized diet counseling developed based on the 2020 Korean Dietary Reference Intakes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Behavioral: Nutritional education and diet counselling
All participants will be asked to visit the study site after the 10-day baseline monitoring period. They will receive a 30-minute nutrition education focusing on reducing UPF intake; and personalized counselling session based on their dietary intake observed during the baseline monitoring period.
Participants allocated to the intervention group will receive nutrition education and personalized counselling aimed at reducing ultra-processed food (UPF) intake by encouraging the substitution of UPFs with unprocessed/minimally processed foods, thereby improving overall diet quality. Participants will be educated on the definition of UPFs, how to identify them, practical strategies for reducing UPF intake, UPF-reducing recipes, and the associations between UPF intake and health outcomes. The content related to UPFs was developed based on previous studies exploring the health effects of UPF intake, while the content on diet quality was based on the 2020 Korean Dietary Reference Intakes.
Conventional nutrition education and diet counseling
All participants will be asked to visit the study site after the 10-day baseline monitoring period. Participants in the control group will receive a conventional nutrient-based education and personalized diet counseling developed based on the 2020 Korean Dietary Reference Intakes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Individuals who are able to wear a continuous glucose monitoring device
* individuals who are willing to participate in follow-up assessments on a voluntary basis
Exclusion Criteria
* Individuals with a risk of bleeding
* Individuals who have previously experienced side effects from continuous glucose monitoring device or who are unable to use the continuous glucose monitoring device
* Individuals who are unable to maintain continuous follow-up due to plans such as travel
20 Years
39 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Korean Society of Cardiometabolic Syndrome (funder)
UNKNOWN
Korea University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hannah Oh
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hannah Oh, ScD
Role: PRINCIPAL_INVESTIGATOR
Department of Health Policy and Management, Korea University, Seoul, Republic of Korea
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Health Promotion Lab, College of Health Science, Korea University
Seoul, Seoul, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Korea National Health and Nutrition Examination Survey (KNHANES): Trend in DIabetes Prevalence (Based on Fasting Blood Glucose or HbA1c). Korea Disease Control and Prevention Agency (KDCA), 2023.
Healthy Eating Habits for Patients with Diabetes. World Health Organization, 2017.
Guidelines for Healthy Eating for Disease Management: Diabetes, Hyperlipidemia, and Hypertension (Volume 3). Ministry of Health and Welfare, Republic of Korea, 2013.
Dicken SJ, Dahm CC, Ibsen DB, Olsen A, Tjonneland A, Louati-Hajji M, Cadeau C, Marques C, Schulze MB, Jannasch F, Baldassari I, Manfredi L, Santucci de Magistris M, Sanchez MJ, Castro-Espin C, Palacios DR, Amiano P, Guevara M, van der Schouw YT, Boer JMA, Verschuren WMM, Sharp SJ, Forouhi NG, Wareham NJ, Vamos EP, Chang K, Vineis P, Heath AK, Gunter MJ, Nicolas G, Weiderpass E, Huybrechts I, Batterham RL. Food consumption by degree of food processing and risk of type 2 diabetes mellitus: a prospective cohort analysis of the European Prospective Investigation into Cancer and Nutrition (EPIC). Lancet Reg Health Eur. 2024 Sep 16;46:101043. doi: 10.1016/j.lanepe.2024.101043. eCollection 2024 Nov.
Cho Y, Ryu S, Kim R, Shin MJ, Oh H. Ultra-processed Food Intake and Risk of Type 2 Diabetes in Korean Adults. J Nutr. 2024 Jan;154(1):243-251. doi: 10.1016/j.tjnut.2023.11.021. Epub 2023 Nov 24.
Chen Z, Khandpur N, Desjardins C, Wang L, Monteiro CA, Rossato SL, Fung TT, Manson JE, Willett WC, Rimm EB, Hu FB, Sun Q, Drouin-Chartier JP. Ultra-Processed Food Consumption and Risk of Type 2 Diabetes: Three Large Prospective U.S. Cohort Studies. Diabetes Care. 2023 Jul 1;46(7):1335-1344. doi: 10.2337/dc22-1993.
Monteiro CA, Cannon G, Levy RB, Moubarac JC, Louzada ML, Rauber F, Khandpur N, Cediel G, Neri D, Martinez-Steele E, Baraldi LG, Jaime PC. Ultra-processed foods: what they are and how to identify them. Public Health Nutr. 2019 Apr;22(5):936-941. doi: 10.1017/S1368980018003762. Epub 2019 Feb 12.
Martini D, Godos J, Bonaccio M, Vitaglione P, Grosso G. Ultra-Processed Foods and Nutritional Dietary Profile: A Meta-Analysis of Nationally Representative Samples. Nutrients. 2021 Sep 27;13(10):3390. doi: 10.3390/nu13103390.
Liu J, Steele EM, Li Y, Karageorgou D, Micha R, Monteiro CA, Mozaffarian D. Consumption of Ultraprocessed Foods and Diet Quality Among U.S. Children and Adults. Am J Prev Med. 2022 Feb;62(2):252-264. doi: 10.1016/j.amepre.2021.08.014. Epub 2021 Nov 6.
Moradi S, Entezari MH, Mohammadi H, Jayedi A, Lazaridi AV, Kermani MAH, Miraghajani M. Ultra-processed food consumption and adult obesity risk: a systematic review and dose-response meta-analysis. Crit Rev Food Sci Nutr. 2023;63(2):249-260. doi: 10.1080/10408398.2021.1946005. Epub 2021 Jun 30.
Mendoza K, Smith-Warner SA, Rossato SL, Khandpur N, Manson JE, Qi L, Rimm EB, Mukamal KJ, Willett WC, Wang M, Hu FB, Mattei J, Sun Q. Ultra-processed foods and cardiovascular disease: analysis of three large US prospective cohorts and a systematic review and meta-analysis of prospective cohort studies. Lancet Reg Health Am. 2024 Sep 2;37:100859. doi: 10.1016/j.lana.2024.100859. eCollection 2024 Sep.
Wang M, Du X, Huang W, Xu Y. Ultra-processed Foods Consumption Increases the Risk of Hypertension in Adults: A Systematic Review and Meta-analysis. Am J Hypertens. 2022 Oct 3;35(10):892-901. doi: 10.1093/ajh/hpac069.
Kim Y, Cho Y, Kim JE, Lee DH, Oh H. Ultra-Processed Food Intake and Risk of Type 2 Diabetes Mellitus: A Dose-Response Meta-Analysis of Prospective Studies. Diabetes Metab J. 2025 Sep;49(5):1064-1074. doi: 10.4093/dmj.2024.0706. Epub 2025 Jun 9.
Cao Y, Liu H, Qin N, Ren X, Zhu B, Xia X. Impact of food additives on the composition and function of gut microbiota: A review. Trends in Food Science & Technology. 2020;99:295-310. doi: https://doi.org/10.1016/j.tifs.2020.03.006.
Simmons AL, Schlezinger JJ, Corkey BE. What Are We Putting in Our Food That Is Making Us Fat? Food Additives, Contaminants, and Other Putative Contributors to Obesity. Curr Obes Rep. 2014 Jun 1;3(2):273-85. doi: 10.1007/s13679-014-0094-y.
Derbyshire E. Are all 'ultra-processed' foods nutritional demons? A commentary and nutritional profiling analysis. Trends in Food Science & Technology. 2019;94:98-104. doi: https://doi.org/10.1016/j.tifs.2019.08.023.
Jung S, Kim JY, Park S. Eating patterns in Korean adults, 1998-2018: increased energy contribution of ultra-processed foods in main meals and snacks. Eur J Nutr. 2024 Feb;63(1):279-289. doi: 10.1007/s00394-023-03258-x. Epub 2023 Nov 24.
Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.
2nd study on application of Dietary reference intakes for Koreans 2020. Ministry of Health and Welfare, The Korean Nutrition Society, 2022.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025-2
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KUIRB-2025-0124
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.