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CompletedNCT06813131Updated Feb 6, 2025

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

An interventional study of Dietary counseling and calling via telephone in Metabolic Syndrome, Metabolic Syndrome Obesity and Metabolic Syndrome Parameters, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2023, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Metabolic Syndrome
  • Metabolic Syndrome Obesity
  • Metabolic Syndrome Parameters

Keywords

  • metabolic syndrome x
  • abdominal obesity
  • medical nutrition therapy
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 93 is above the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Participants in this group attended face-to-face consultations at baseline, and at the 1st, 2nd, and 3rd months (a total of four visits). These sessions focused on providing guidance for dietary and lifestyle modifications.

    Other: Dietary counseling · Other: calling via telephone

  • Experimental
    Intensive Intervention

    This group followed the same face-to-face consultation schedule as the intervention group (baseline, 1st, 2nd, and 3rd months). In addition, participants were contacted weekly via phone to assess dietary adherence and provide ongoing motivation and support, making this a more frequent and intensive intervention. Across all groups, the study primarily aimed to evaluate changes in weight loss, blood sugar, lipid levels, and metabolic syndrome parameters, while assessing the impact of intervention intensity on these outcomes.

    Other: Dietary counseling

  • No intervention
    Control Group

    Participants in this group were seen in person only twice, at baseline and at the 3rd month. No additional interventions were applied, and the aim was to observe the natural course of their condition.

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."

06

What researchers measure

Primary outcomes

  1. waist circumference

    Waist 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.

    Time frame: Baseline, 1 month, 2 months, and 3 months after the start of the intervention

Secondary outcomes

  1. fasting plasma glucose, triglyceride, HDL-C and blood pressure (Number of metabolic syndrome criteria)

    The 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.

    Time frame: Baseline, 1 month, 2 months, and 3 months after the start of the intervention

07

Study locations

1 site
  • Goztepe Prof. Dr. Suleyman Yalcin City Hospital
    Istanbul, Kadıkoy, Turkey
08

References and documents

Publications

  • Zujko ME, Rozniata M, Zujko K. Individual Diet Modification Reduces the Metabolic Syndrome in Patients Before Pharmacological Treatment. Nutrients. 2021 Jun 19;13(6):2102. doi: 10.3390/nu13062102. PubMed 34205362 ↗
  • Alfawaz HA, Wani K, Alnaami AM, Al-Saleh Y, Aljohani NJ, Al-Attas OS, Alokail MS, Kumar S, Al-Daghri NM. Effects of Different Dietary and Lifestyle Modification Therapies on Metabolic Syndrome in Prediabetic Arab Patients: A 12-Month Longitudinal Study. Nutrients. 2018 Mar 20;10(3):383. doi: 10.3390/nu10030383. PubMed 29558423 ↗
  • Parker AR, Byham-Gray L, Denmark R, Winkle PJ. The effect of medical nutrition therapy by a registered dietitian nutritionist in patients with prediabetes participating in a randomized controlled clinical research trial. J Acad Nutr Diet. 2014 Nov;114(11):1739-48. doi: 10.1016/j.jand.2014.07.020. Epub 2014 Sep 11. PubMed 25218597 ↗

Individual participant data

Plan to share: Yes

Supporting information: Icf

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06813131
Lead sponsor
Hacettepe University
Responsible party
Kubra Yildiz Guler (Research University, Hacettepe University) — Principal investigator
First posted
Feb 6, 2025
Start date
Oct 14, 2023
Primary completion
Jul 5, 2024
Completion
Jul 5, 2024
Last update
Feb 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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