Ultra-processed Food-reducing Intervention and Continuous Glucose Monitoring
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-39
SponsorKorea University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
40-minute one-on-one dietary counseling and nutrition education aimed at reducing ultra-processed food consumption
BehavioralParticipants 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.
Standard dietary counseling and nutrition education based on national guidelines
BehavioralParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
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
1
Change in coefficient of variation (CV)
CV indicates relative glycemic variability and is calculated as the standard deviation of glucose measurements assessed using CGM divided by the mean glucose level.
Time frame
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)2
Change in standard deviation (mg/dL)
Standard deviation represents the absolute magnitude of glycemic variability, reflecting the dispersion of glucose values over time, assessed using CGM.
Time frame
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)3
Change in mean amplitude of glycemic excursions (MAGE)
Mean amplitude of glycemic excursions represents the mean amplitude of major glucose excursions. It is calculate by mean height of glycemic excursions (peaks and nadirs) that exceed one SD of the mean glucose over a 24-hour period.
Time frame
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)4
Change in glucose spike frequency
Glucose spike frequency quantifies the number of distinct glucose excursions above 140 mg/dL, providing an additional measure of postprandial hyperglycemia.
Time frame
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)Sponsors and contacts
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Korea University
Lead sponsor
Korean Society of Cardiometabolic Syndrome (funder)
Collaborator
Source ClinicalTrials.gov