The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.
David Moher, Kenneth F Schulz, Douglas G Altman...
https://pubmed.ncbi.nlm.nih.gov/12673431Actively Recruiting
Phase Not Applicable
Age: 20Years - 39Years
All Genders
Healthy Volunteers
ID07175701
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
Led by Korea University · Updated on 2026-04-17
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Korea University
Lead Sponsor
K
Korean Society of Cardiometabolic Syndrome (funder)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating if reducing ultra-processed food intake can improve blood sugar responses after meals and reduce blood sugar swings in young, healthy Korean adults aged 20 to 39 years. This trial compares a special dietary counseling focused on lowering ultra-processed foods with standard nutrition education based on national guidelines. The study aims to provide evidence on how cutting back on ultra-processed foods affects metabolism and may help prevent diabetes in younger adults. Participants first wear a continuous glucose monitoring (CGM) device for 10 days while recording their diet and lifestyle habits. Then, they are randomly assigned to one of two groups: the intervention group receives a 40-minute personalized counseling session aimed at reducing ultra-processed food consumption, while the control group receives standard dietary counseling without focus on ultra-processed foods. After the counseling, participants wear a new CGM device for another 10 days and continue tracking their food intake and lifestyle behaviors. Throughout the study, researchers measure changes in the participants’ blood sugar levels after meals and overall blood sugar variability by comparing data from before and after the intervention. They also track body weight, waist size, body fat, muscle mass, blood pressure, and handgrip strength from the start to the end of the study, which lasts about 23 days. Participants’ adherence to recording their diet and lifestyle during both monitoring periods is closely supported by the study team.
CONDITIONS
Brief Title
Ultra-processed Food-reducing Intervention and Continuous Glucose Monitoring
Who Can Participate
Age: 20Years - 39Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Korean adults aged 20 to 39 years
- Not currently pregnant
- No personal history of diabetes or other glucose-related conditions
- Consume at least 25% of daily energy intake from ultra-processed foods as assessed by a screening questionnaire
- Able to wear a continuous glucose monitoring (CGM) device
- No increased risk of bleeding
- No prior adverse reaction to CGM devices
- Willing to participate in follow-up assessments
You will not qualify if you...
- Unable to maintain continuous follow-up during the study period (e.g., due to travel plans)
- Planning to follow a special or restrictive diet (such as for weight loss) during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Monitoring
Duration - 10 days
Participants wear continuous glucose monitoring (CGM) devices to monitor glucose levels before the intervention.
Monitoring with CGM devices over 10 days
Behavioral Intervention
Duration - 1 day
Participants receive a 40-minute one-on-one nutrition education session and personalized dietary counseling to reduce ultra-processed food consumption or standard dietary counseling based on national guidelines depending on group assignment.
1 session (in-person)
Post-Intervention Monitoring
Duration - 10 days
Participants continue wearing CGM devices to assess changes in glucose responses and glycemic variability following the intervention.
Monitoring with CGM devices over 10 days
Follow-up Assessments
Duration - Up to 10 days after intervention
Participants complete follow-up assessments including body weight, waist circumference, fat mass, muscle mass, body fat percentage, blood pressure, and handgrip strength measurements.
1 to 2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Health Promotion Lab, College of Health Science, Korea University
Seoul, Seoul, South Korea, 02841
Actively Recruiting
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Research Team
Y
Yujin Kim, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Eating vegetables before carbohydrates improves postprandial glucose excursions.
S Imai, M Fukui, N Ozasa...
https://pubmed.ncbi.nlm.nih.gov/23167256Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor.
James H O'Keefe, David S H Bell
https://pubmed.ncbi.nlm.nih.gov/17719342Real-life glycaemic profiles in non-diabetic individuals with low fasting glucose and normal HbA1c: the A1C-Derived Average Glucose (ADAG) study.
R Borg, J C Kuenen, B Carstensen...
https://pubmed.ncbi.nlm.nih.gov/20396998Variation of interstitial glucose measurements assessed by continuous glucose monitors in healthy, nondiabetic individuals.
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, Larry A Fox, Roy W Beck...
https://pubmed.ncbi.nlm.nih.gov/20215454Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study.
Viral N Shah, Stephanie N DuBose, Zoey Li...
https://pubmed.ncbi.nlm.nih.gov/31127824Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range.
Tadej Battelino, Thomas Danne, Richard M Bergenstal...
https://pubmed.ncbi.nlm.nih.gov/31177185Individual Postprandial Glycemic Responses to Meal Types by Different Carbohydrate Levels and Their Associations with Glycemic Variability Using Continuous Glucose Monitoring.
Jiwoo Song, Tae Jung Oh, YoonJu Song
https://pubmed.ncbi.nlm.nih.gov/37630761Ultra-processed foods and cardiovascular disease: analysis of three large US prospective cohorts and a systematic review and meta-analysis of prospective cohort studies.
Kenny Mendoza, Stephanie A Smith-Warner, Sinara Laurini Rossato...
https://pubmed.ncbi.nlm.nih.gov/39286398Ultra-processed Foods Consumption Increases the Risk of Hypertension in Adults: A Systematic Review and Meta-analysis.
Mei Wang, Xinyi Du, Wei Huang...
https://pubmed.ncbi.nlm.nih.gov/35750049