Clinical trial NCT02028585: Effects of Low Fat Milk Consumption on Metabolic Syndrome
Official title: Effects of Low-fat Milk Consumption on Metabolic and Atherogenic Biomarkers in Korean Adults With Metabolic Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: low-fat milk
metabolic syndrome
lipid profile
inflammation
oxidative stress
endothelial function
Lead sponsor: Ministry of Food and Drug Safety, Korea
Sponsor class: OTHER_GOV
First posted: 2014-01-07
Enrollment: 58
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: metabolic parameters
timeFrame: 6 weeks
measure: inflammation markers
timeFrame: 6 weeks
measure: Endo-peripheral artery tonometry (EndoPAT) index
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan-si
country: Korea, Republic of
facility: Department of Endocrinology and Metabolism, Korea University Ansan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Endocrinology and Metabolism, Korea University Ansan Hospital
name: Nan Hee Kim, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YJ, Seo JA, Yoon T, Seo I, Lee JH, Im D, Lee JH, Bahn KN, Ham HS, Jeong SA, Kang TS, Ahn JH, Kim DH, Nam GE, Kim NH. Effects of low-fat milk consumption on metabolic and atherogenic biomarkers in Korean adults with the metabolic syndrome: a randomised controlled trial. J Hum Nutr Diet. 2016 Aug;29(4):477-86. doi: 10.1111/jhn.12349. Epub 2016 Mar 6.