Effects of Nut Consumption on Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023749
• Other study ID #: 12161MFDS118
• Secondary ID: 12161MFDS118
• Status: Completed
• Phase: N/A
• First received: December 17, 2013
• Last updated: December 23, 2013
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: December 2013
• Source: Ministry of Food and Drug Safety, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Nut group

Locations

Country	Name	City	State
Korea, Republic of	Department of Endocrinology and Metabolism, Korea University Ansan Hospital	Ansan-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No