The Effect of Personalized Nutrition on Changes in Metabolic Parameters in Patients With Type 2 D… (NCT07696013) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Personalized Nutrition on Changes in Metabolic Parameters in Patients With Type 2 Diabetes Mellitus
Indonesia60 participantsStarted 2025-10-01
Plain-language summary
Type 2 diabetes mellitus (T2DM) is a multifactorial metabolic disorder commonly accompanied by obesity, hypertension, and suboptimal glycemic control, which together increase cardiovascular risk. Conventional dietary recommendations often apply a uniform approach and may not adequately address interindividual metabolic variability. Personalized nutrition has therefore gained attention as a strategy to optimize metabolic outcomes through individualized dietary interventions. This controlled intervention study evaluated the effect of a personalized nutrition program "my plate" on metabolic parameters in patients with T2DM. Participants were assigned to either an intervention group receiving personalized dietary guidance or a control group receiving standard care. Anthropometric parameters (body weight, body mass index, and waist circumference), fasting plasma glucose, and blood pressure were assessed at baseline and after the intervention
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female participants aged \>18 years
* A confirmed diagnosis of type 2 diabetes mellitus based on the Fasting Blood Glucose more than 126 mg/dL
* Willingness to participate in dietary counseling sessions and undergo metabolic assessments throughout the study period
* Provision of written informed consent prior to participation
Exclusion Criteria:
* Currently following a special or therapeutic diet prescribed by a physician or dietitian
* Previous receipt of dietary counseling
* Presence of comorbid conditions known to affect metabolic function, as identified through a standardized screening questionnaire
* Use of weight-loss medications or metabolically active dietary supplements, as determined by the screening form
* Pregnancy or lactation, as assessed by medical history and physical examination
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested personalized nutrition for Type 2 Diabetes and has already been completed — would it be worth asking the researchers or my doctor if the results have been published, and what those results showed about metabolic changes like blood sugar, cholesterol, or weight?
2Since this study was categorized as 'Phase NA,' meaning it wasn't a traditional drug trial with phased safety testing, what does my doctor think about the level of evidence this kind of nutrition study provides compared to medication-based treatments for my diabetes?
3Personalized nutrition can mean very different things — would my doctor know what specific dietary approach was used in this trial, and whether something similar might be a realistic option for managing my own metabolic profile?
4Given that this trial is already completed, are there other ongoing nutrition or lifestyle intervention studies for Type 2 Diabetes that my doctor thinks might be a better fit for me right now?
5Before considering any findings from this trial, would my doctor recommend first optimizing my current standard diabetes treatment plan, or does personalized nutrition sound like something worth exploring alongside what I'm already doing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.