Effects of Nut Consumption on Metabolic Syndrome

Effects of Nut Consumption on Metabolic Syndrome in Korean Adults - A Randomized Controlled Dietary Intervention Trial

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

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Nut group

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 Nut group, which were supplemented with 30 g of mixed nuts including walnuts, peanuts, and pine nuts for 6 weeks; or allocated to the Control group. Metabolic markers were evaluated at baseline and at the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, Korea, Republic of, 425-707
      • Department of Endocrinology and Metabolism, Korea University Ansan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• Subjects were excluded if they had a nut allergy, peptic disorder, a history of cancer or cardiovascular disease including coronary artery disease, heart valve disease, or stroke, or established chronic diseases such as chronic renal insufficiency or cirrhosis. Subjects were also excluded if they:1) were receiving treatment with hypoglycemic agents for diabetes or had HbA1c >7%; 2) were receiving corticosteroid treatment; 3) had started antihypertensive or lipid-lowering agents, or changed their doses within the previous month; 4) had a weight change ≥5 % of body weight during the three months prior to the study; 5) were pregnant; or 6) were regular nut consumers (>15g/day of nuts at least three times a week).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nut group; Subjects were supplemented with 30 g of mixed nuts including walnuts, peanuts, and pine nuts for 6 weeks	Dietary supplement: Nut group
No Intervention: Control group; Control group maintained their usual diet without nut supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
metabolic parameters	lipid profiles, body mass index, waist circumference, blood pressure, fasting glucose, insulin, hemoglobin A1c and homeostasis model assessment of insulin resistance	6 weeks
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)	6 weeks
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.	6 weeks

Collaborators and Investigators

• Sponsor: Ministry of Food and Drug Safety, Korea
• Investigators: Principal Investigator: Nan Hee Kim, Prof, Department of Endocrinology and Metabolism, Korea University Ansan Hospital

Publications and helpful links

General Publications

• Lee YJ, Nam GE, Seo JA, Yoon T, Seo I, Lee JH, Im D, Bahn KN, Jeong SA, Kang TS, Ahn JH, Kim DH, Kim NH. Nut consumption has favorable effects on lipid profiles of Korean women with metabolic syndrome. Nutr Res. 2014 Sep;34(9):814-20. doi: 10.1016/j.nutres.2014.08.011. Epub 2014 Aug 30.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: December 17, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Estimate): December 30, 2013
• Last Update Submitted That Met QC Criteria: December 23, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: inflammation; oxidative stress; metabolic syndrome; endothelial function; lipid profile; nuts
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 12161MFDS118 (Other Grant/Funding Number: Ministry of Food and Drug Safety)