Ultra-processed Food-reducing Intervention and Continuous Glucose Monitoring

NCT07175701 | Recruiting

• 2 other identifiers: KUIRB-2025-0600-052025-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Postprandial Glucose; Glucose Levels; Hyperglycemias

Keywords

ultra-processed food; continuous glucose monitoring; processed food; glucose; glycemic variability; glycemic control; hyperglycemia; glucose intolerance; Food Additives; flavoring agents; sweetening agents; non-nutritive sweeteners; nutritive sweeteners; high fructose corn syrup; food coloring agents; food preservatives

Outcome Measures

Primary Outcomes (1)

• Change in postprandial glucose responses

  The primary outcome of this study is the change in postprandial glucose responses from the baseline monitoring period to the post-intervention monitoring period. Postprandial glucose responses are assessed using CGM and quantified as the incremental area under the curve (iAUC) over 2 hours following each meal. Higher iAUC values indicate greater postprandial glucose excursions. For each meal, iAUC is calculated as the area under the curve above the baseline level over the 2-hour postprandial period, using the trapezoidal rule. The baseline glucose level is defined as the mean glucose value in the 5 minutes immediately preceding meal consumption. For overlapping meals, the iAUC for the first meal is calculated from its start until 2 hours after, and overlapping periods are excluded from subsequent meals' iAUC to ensure each glucose excursion is counted once.

  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)

Secondary Outcomes (15)

• Change in coefficient of variation (CV)

  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)

  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)

  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

  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 (%)

  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)

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will be randomly assigned to the intervention group using block randomization with a 1:1 allocation ratio.

Behavioral: 40-minute one-on-one dietary counseling and nutrition education aimed at reducing ultra-processed food consumption

Control group

ACTIVE COMPARATOR

Participants will be randomly assigned to the control group using block randomization with a 1:1 allocation ratio.

Behavioral: Standard dietary counseling and nutrition education based on national guidelines

Interventions

40-minute one-on-one dietary counseling and nutrition education aimed at reducing ultra-processed food consumption BEHAVIORAL

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 to participant enrollment.

Intervention group

Standard dietary counseling and nutrition education based on national guidelines BEHAVIORAL

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 group are provided with the same nutrition education materials on UPF reduction that are used in the intervention group.

Control group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University: lead
• Korean Society of Cardiometabolic Syndrome (funder): collaborator

Study Sites (1)

Health Promotion Lab, College of Health Science, Korea University

Seoul, Seoul, 02841, South Korea

RECRUITING

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MeSH Terms

Conditions

Hyperglycemia; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hannah Oh, ScD

  Department of Health Policy and Management, Korea University, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujin Kim, BSN

CONTACT

+82-10-8712-9763; iamyujin@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors were blinded to group allocation. The study dietitian responsible for delivering the intervention was not blinded; however, allocation was concealed until the time of intervention delivery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 16, 2025
• Study Start: October 11, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)