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Effects of Low Fat Milk Consumption on Metabolic Syndrome

M

Ministry of Food and Drug Safety, Korea

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: Low-fat milk group

Study type

Interventional

Funder types

Other

Identifiers

NCT02028585
12161MFDS118 (Other Grant/Funding Number)
12162-mfds-118

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

35 to 65 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 2 patient groups

Low-fat milk group
Active Comparator group
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.
Treatment:
Dietary Supplement: Low-fat milk group
Control group
No Intervention group
Description:
Control group maintained their usual diet without low-fat milk supplement.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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