Effects of Nut Consumption on Metabolic Syndrome
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 17, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedDecember 30, 2013
December 1, 2013
4 months
December 17, 2013
December 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Nut group
ACTIVE COMPARATORSubjects were supplemented with 30 g of mixed nuts including walnuts, peanuts, and pine nuts for 6 weeks
Control group
NO INTERVENTIONControl group maintained their usual diet without nut supplement
Interventions
Eligibility Criteria
You may qualify if:
- Subjects were enrolled if their body mass index (BMI) was ≥23 kg/m2 and they met the criteria for metabolic syndrome.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Endocrinology and Metabolism, Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 425-707, South Korea
Related Publications (1)
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.
PMID: 25238912DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nan Hee Kim, Prof
Department of Endocrinology and Metabolism, Korea University Ansan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
December 17, 2013
First Posted
December 30, 2013
Study Start
April 1, 2012
Primary Completion
August 1, 2012
Study Completion
October 1, 2012
Last Updated
December 30, 2013
Record last verified: 2013-12