NCT02023749

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

December 17, 2013

Last Update Submit

December 23, 2013

Conditions

Keywords

nutsmetabolic syndromelipid profileinflammationoxidative stressendothelial function

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 COMPARATOR

Subjects were supplemented with 30 g of mixed nuts including walnuts, peanuts, and pine nuts for 6 weeks

Dietary Supplement: Nut group

Control group

NO INTERVENTION

Control group maintained their usual diet without nut supplement

Interventions

Nut groupDIETARY_SUPPLEMENT
Nut group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Metabolic SyndromeInflammation

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nan Hee Kim, Prof

    Department of Endocrinology and Metabolism, Korea University Ansan Hospital

    PRINCIPAL INVESTIGATOR

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

Locations