NCT01617525

Brief Summary

The primary aim of this study is to compare, in a group of at-risk individuals, the role of three dietary patterns on indices of Cardiovascular Disease (CVD) risk: a) the recommended Korean pattern; b) the typical American diet, based on national dietary intake surveys; and c) the 2010 DGA diet pattern. A secondary aim will be to assess the effects of each diet on intestinal microbiota and on inflammatory biomarkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

March 31, 2012

Last Update Submit

May 10, 2016

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Disease Biomarkers

    Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured.

    End of each 4-week diet period

Secondary Outcomes (6)

  • Inflammatory Markers

    End of each 4-week diet

  • Markers of appetite and food intake regulation

    End of each 4-week diet

  • Blood pressure

    End of each 4-week diet

  • Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine

    End of each 4-week diet

  • Change in fecal microbiota

    At baseline and after 4-weeks of each diet

  • +1 more secondary outcomes

Study Arms (3)

Korean Recommended Diet

EXPERIMENTAL

A dietary pattern that follows the recommendations by the Korean Rural Development Administration.

Other: Controlled Feeding Dietary Intervention

US Recommended Diet

ACTIVE COMPARATOR

Diet based on recipes and menus developed by the USDA Dietary Guidelines for Americans intramural team.

Other: Controlled Feeding Dietary Intervention

Typical American Diet

ACTIVE COMPARATOR

Diet based on data from the NHANES surveys, as summarized in the USDA report What We Eat in America.

Other: Controlled Feeding Dietary Intervention

Interventions

Controlled Feeding Dietary InterventionOTHER

All meals will be provided during each 4-week intervention period. Participants must consume all foods provided and must not consume any outside foods during each intervention period.

Korean Recommended DietTypical American DietUS Recommended Diet

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non Asian-American men and women between the ages of 25-65 years
  • Body Mass Index (BMI) ≥ 25 and ≤ 38 kg/m2
  • Fasting LDL-cholesterol ≥ 130 mg/dL
  • Willingness and ability to make scheduled appointments at clinical site as required by study protocol

You may not qualify if:

  • Major aversions to Korean foods
  • Known food allergies that would interfere with study protocol
  • Use of cholesterol-lowering medication or dietary supplements
  • Use of blood pressure medications
  • Use of prebiotics or probiotics in the last 3 months
  • Received medication for bacterial infection (antibiotic) in the last 3 months
  • Regular use of fiber supplements or laxatives
  • Conditions requiring ongoing medical care and/or medication, including kidney, liver, gastrointestinal or endocrine disorders.
  • Regular tobacco use within 6 months prior to the start of the study
  • History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
  • Voluntary or involuntary weight loss of 10% of body weight within the last 12 months
  • Self-report of alcohol or substance abuse within the past 12 months
  • Donated blood during the 8 week period prior to the study
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study anticipation or the ability to follow the intervention protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

  • Schroeder N, Park YH, Kang MS, Kim Y, Ha GK, Kim HR, Yates AA, Caballero B. A randomized trial on the effects of 2010 Dietary Guidelines for Americans and Korean diet patterns on cardiovascular risk factors in overweight and obese adults. J Acad Nutr Diet. 2015 Jul;115(7):1083-92. doi: 10.1016/j.jand.2015.03.023.

    PMID: 26115560DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2012

First Posted

June 12, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

US(1)