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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07696013
Enrollment
60
Registered
2026-07-10
Start date
2025-10-01
Completion date
2026-01-31
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Blood pressure; Glycemic control; Metabolic health; Obesity; Personalized nutrition; Type 2 diabetes mellitus

Brief 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

Interventions

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

Sponsors

DINA KEUMALA SARI
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Metabolic ProfileBaseline, and 12 weeksChange in Fasting Plasma Glucose (mg/dL)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026