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Impact of Medical Nutrition Therapy and Follow-Up Frequency on Metabolic Syndrome Parameters

The Effect of Medical Nutrition Therapy and Follow-Up Frequency on Parameters Related to Metabolic Syndrome in Individuals With Metabolic Syndrome: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06813131
Enrollment
93
Registered
2025-02-06
Start date
2023-10-14
Completion date
2024-07-05
Last updated
2025-02-06

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

Conditions

Metabolic Syndrome, Metabolic Syndrome Obesity, Metabolic Syndrome Parameters

Keywords

metabolic syndrome x, abdominal obesity, medical nutrition therapy

Brief summary

There is no study that has investigated the effects of medical nutrition therapy and more frequent follow-up via telehealth on metabolic syndrome parameters in patients with MetS who have multiple metabolic disorders such as being overweight, prediabetic/diabetic, dyslipidemic and having increased blood pressure. This study was conducted to examine the effects of medical nutrition therapy and increased follow-up via telephone calls on MetS-related parameters in individuals with MetS.

Interventions

OTHERDietary counseling

This intervention uniquely focuses on the frequency of dietitian-led follow-up visits and their impact on metabolic syndrome-related parameters. The study includes three distinct groups with varying levels of follow-up intensity (control, intervention, and intensive intervention).

OTHERcalling via telephone

The intensive intervention group involves weekly diet adherence assessments via phone calls, setting it apart from other studies that typically rely on less frequent or standardized follow-up schedules. This design allows for the evaluation of how consultation frequency influences outcomes such as weight loss, blood sugar levels, lipid profile, and metabolic syndrome components.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Three groups: Intervention group, Intensive intervention group, Control group

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Individuals with HbA1c values \<8.5% * Diagnosed with MetS by a physician according to the criteria declared by the consensus of the International Diabetes Federation Task Force on Epidemiology and Prevention, National Heart, Lung, and Blood Institute, American Heart Association, World Heart Federation, International Atherosclerosis Society, and International Association for the Study of Obesity were included.

Exclusion criteria

* Taking anti diabetic agents other then metformin * Taking anti hyperlipidemic agents * Taking anti hypertensive agents * Using food supplements (w-3, chromium, multivitamins) that could affect metabolic parameters, * Having kidney failure, * Having liver failure, * Having immune failure * Having chronic gastrointestinal system disease * Having cancer * Having type 1 diabetes * Being pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frameDescription
waist circumferenceBaseline, 1 month, 2 months, and 3 months after the start of the interventionWaist circumference, which is an indicator of abdominal obesity, the central component of metabolic syndrome, was determined as the primary outcome because of its strong association with cardiometabolic risk and its correlation with other MetS components, and because it is a significant measure in reflecting the overall effect of the intervention.

Secondary

MeasureTime frameDescription
fasting plasma glucose, triglyceride, HDL-C and blood pressure (Number of metabolic syndrome criteria)Baseline, 1 month, 2 months, and 3 months after the start of the interventionThe change in the number of individuals with the following metabolic syndrome criteria has been determined as a secondary outcome: * Elevated fasting plasma glucose (number of individuals with ≥100 mg/dL), * Elevated triglycerides (number of individuals with ≥150 mg/dL), * Low HDL-C (number of individuals with \<50 mg/dL in women and \<40 mg/dL in men), * Elevated blood pressure (number of individuals with systolic ≥130 mmHg and/or diastolic ≥85 mmHg). Multiple assessments with different units of measurement will be combined into a single reported value based on the change in the number of individuals meeting these conditions.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026