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Effects of Nut Consumption on Metabolic Syndrome

NCT ID: NCT02023749

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome

Keywords

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nuts metabolic syndrome lipid profile inflammation oxidative stress endothelial function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nut group

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

Group Type ACTIVE_COMPARATOR

Nut group

Intervention Type DIETARY_SUPPLEMENT

Control group

Control group maintained their usual diet without nut supplement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nut group

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Food and Drug Safety, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nan Hee Kim

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nan Hee Kim, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Metabolism, Korea University Ansan Hospital

Locations

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Department of Endocrinology and Metabolism, Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 25238912 (View on PubMed)

Other Identifiers

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12161MFDS118

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12161MFDS118

Identifier Type: -

Identifier Source: org_study_id