Skip to main content
OpenTrials
Completed

NCT Number: NCT02028585

Effects of Low Fat Milk Consumption on Metabolic Syndrome

This study aimed to investigate the effects of low-fat milk consumption on metabolic parameters and biomarkers related to inflammation, oxidative stress, and endothelial function in Korean adults with metabolic syndrome.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology and Metabolism, Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, 425-707, South Korea

About this study

A randomized, controlled, parallel, dietary intervention study was designed. Subjects with metabolic syndrome and body mass index ≥23 kg/m2 were randomized to the low-fat milk group, which were instructed to consume 2 packs of low-fat milk per day (200 mL twice daily) for 6 weeks, and the control group was instructed to maintain their habitual diet. Metabolic markers were evaluated at baseline and at the end of the study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects were enrolled if their body mass index (BMI) was ≥23 kg/m2 and they met the criteria for metabolic syndrome.

Exclusion criteria

  • Those who were allergic to milk; those who had a history of digestive disorder; those with a medical history of cardiovascular diseases, including coronary artery diseases, valvular heart diseases, heart failure, or stroke; those who had cancer in the past 5 years; those who were taking hypoglycemic agents for diabetes mellitus; those who had chronic disease such as renal failure or liver cirrhosis; and those with a hemoglobin A1c (HbA1c) level ≥ 7% were excluded from the research. People who had a weight change > 5% of the total weight within the past 3 months, those who had started taking or had changed their dose of anti-hypertensive agents or medications for dyslipidemia within the previous 1 month, those who had a newly diagnosed dyslipidemia requiring drug treatment, those who had taken steroids either orally or by injection within the previous 3 months, those who were pregnant or were expecting to become pregnant; and those who regularly consumed milk in quantities ≥ 200 mL per day at least 3 times a week on average were also excluded.

Treatment and study plan

Low-fat milk group

Dietary Supplement

Primary outcomes

  1. metabolic parameters

    Time frame: 6 weeks

    lipid profiles, body mass index, waist circumference, blood pressure, fasting glucose, insulin, hemoglobin A1c and homeostasis model assessment of insulin resistance

  2. inflammation markers

    Time frame: 6 weeks

    white blood cell count, high-sensitive C-reactive protein, Interleukin-6, adiponectin, serum and urine malondialdehyde, oxidized low-density lipoprotein, vascular cell adhesion molecule (VCAM) and intercellular adhesion molecule (ICAM)

  3. Endo-peripheral artery tonometry (EndoPAT) index

    Time frame: 6 weeks

    EndoPAT index was assessed to evaluate endothelial function by using a finger plethysmograph based on non-invasive peripheral artery tonometry.

Sponsors and collaborators

Lead sponsor

Ministry of Food and Drug Safety, Korea

Other Gov

Registry information

Official study title

Effects of Low-fat Milk Consumption on Metabolic and Atherogenic Biomarkers in Korean Adults With Metabolic Syndrome: a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 7, 2014
Registry last updated
Jan 7, 2014

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.

Published trials that share one or more normalized conditions with this study.