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Effects of Low Fat Milk Consumption on Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Low-fat milk group

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring low-fat milk, metabolic syndrome, lipid profile, inflammation, oxidative stress, endothelial function

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Department of Endocrinology and Metabolism, Korea University Ansan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Low-fat milk group

Control group

Arm Description

The low-fat milk group was instructed to consume 2 packs of low-fat milk per day (200 mL twice daily) for 6 weeks.

Control group maintained their usual diet without low-fat milk supplement.

Outcomes

Primary Outcome Measures

metabolic parameters

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

inflammation markers

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)

Endo-peripheral artery tonometry (EndoPAT) index

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02028585

First Posted

December 30, 2013

Last Updated

December 30, 2013

Sponsor

Ministry of Food and Drug Safety, Korea

1. Study Identification

Unique Protocol Identification Number

NCT02028585

Brief Title

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

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ministry of Food and Drug Safety, Korea

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

low-fat milk, metabolic syndrome, lipid profile, inflammation, oxidative stress, endothelial function

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low-fat milk group

Arm Type

Active Comparator

Arm Description

The low-fat milk group was instructed to consume 2 packs of low-fat milk per day (200 mL twice daily) for 6 weeks.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Control group maintained their usual diet without low-fat milk supplement.

Intervention Type

Dietary Supplement

Intervention Name(s)

Low-fat milk group

Primary Outcome Measure Information:

Title

metabolic parameters

Description

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

Time Frame

6 weeks

Title

inflammation markers

Description

Time Frame

6 weeks

Title

Endo-peripheral artery tonometry (EndoPAT) index

Description

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nan Hee Kim, Prof

Organizational Affiliation

Department of Endocrinology and Metabolism, Korea University Ansan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Endocrinology and Metabolism, Korea University Ansan Hospital

City

Ansan-si

State/Province

Gyeonggi-do

ZIP/Postal Code

425-707

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26945812

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.

Results Reference

derived

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Effects of Low Fat Milk Consumption on Metabolic Syndrome

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