Effects of Nut Consumption on Metabolic Syndrome

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Nut group


Participation Criteria
=================
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: 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).

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nut group<br>Subjects were supplemented with 30 g of mixed nuts including walnuts, peanuts, and pine nuts for 6 weeks | Dietary Supplement: Nut group<br> <br> |
| No Intervention: Control group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nuts, metabolic syndrome, lipid profile, inflammation, oxidative stress, endothelial function