Clinical trial NCT06813131: Impact of Medical Nutrition Therapy and Follow-Up Frequency on Metabolic Syndrome Parameters
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Metabolic Syndrome Obesity
Metabolic Syndrome Parameters
Keywords: metabolic syndrome x
abdominal obesity
medical nutrition therapy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups: Intervention group, Intensive intervention group, Control group
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: waist circumference
timeFrame: Baseline, 1 month, 2 months, and 3 months after the start of the intervention
Secondary outcomes:
measure: fasting plasma glucose, triglyceride, HDL-C and blood pressure (Number of metabolic syndrome criteria)
timeFrame: Baseline, 1 month, 2 months, and 3 months after the start of the intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital
state: Kadıkoy
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.