The Effect of Personalized Nutrition on Changes in Metabolic Parameters in Patients With Type 2 Diabetes Mellitus

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

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition Department, Universitas Sumatera Utara, Medan, Indonesia

Medan, North Sumatera, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized Nutrition

Other

Personalized nutrition based on individual calorie calculation is an approach that adjusts a person's energy intake and macronutrient composition according to their estimated caloric needs derived from age, sex, body weight, height, and physical activity level.

Generalized Nutrition

Other

Generalized Nutrition means giving the dietary counseling that recommended by health ministry of Indonesia

Primary outcomes

Metabolic Profile

Time frame: Baseline, and 12 weeks

Change in Fasting Plasma Glucose (mg/dL)

Sponsors and collaborators

Lead sponsor

DINA KEUMALA SARI

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jul 10, 2026
Registry last updated: Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed