HypercholesterolemiaNCT01617525
A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles
A study of Hypercholesterolemia, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
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.
- Conditions
- Hypercholesterolemia
- Being tested
- Controlled Feeding Dietary Intervention
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Korean Recommended Diet | Experimental | A dietary pattern that follows the recommendations by the Korean Rural Development Administration. Receives: 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. Receives: 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. Receives: Other: Controlled Feeding Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Disease Biomarkers
Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured.
Measured: End of each 4-week diet period
Secondary outcomes (6)
Inflammatory Markers
Cytokine production will be analyzed by selecting representative pro-inflammatory cytokine genes (i.e. TNF-a, IL-12, IL-6, IFNg), anti-inflammatory genes (IL-10), and different signaling pathways (i.e. Mitogen activated protein kinase (MAPK) p38, phosphatidylinositol 3 (PI3) kinase, and nuclear factor Kappa B (NF-KB).
Measured: End of each 4-week diet
Markers of appetite and food intake regulation
Plasma adiponectin, ghrelin, PYY and leptin will be measured.
Measured: End of each 4-week diet
Blood pressure
Measured: End of each 4-week diet
Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine
Measured: End of each 4-week diet
Change in fecal microbiota
Fecal samples will be collected to study changes in bacterial abundance of commensal microorganisms such as Bifidobacterium spp., Lactobacillus spp., E.coli spp. and Bacteroides fragilis spp.
Measured: At baseline and after 4-weeks of each diet
Dietary Questionnaires
Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms.
Measured: At end of each 4-week diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617525
- Sponsor's protocol ID
- Korean Diet Study
- Status last verified
- May 2016
- First submitted
- 31 Mar 2012
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26115560
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles
- ClinicalTrials.gov ID
- NCT01617525
- Acronym / sponsor ID
- Korean Diet Study
- Conditions
- Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Korean Recommended Diet | Experimental | Other: Controlled Feeding Dietary InterventionA dietary pattern that follows the recommendations by the Korean Rural Development Administration. |
| US Recommended Diet | Active comparator | Other: Controlled Feeding Dietary InterventionDiet based on recipes and menus developed by the USDA Dietary Guidelines for Americans intramural team. |
| Typical American Diet | Active comparator | Other: Controlled Feeding Dietary InterventionDiet based on data from the NHANES surveys, as summarized in the USDA report What We Eat in America. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled Feeding Dietary InterventionAll 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. | Other | Korean Recommended Diet, Typical American Diet, US Recommended Diet |
Primary outcome
Cardiovascular Disease Biomarkers
Time frame: End of each 4-week diet period
Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured.
6 secondary outcomes
Inflammatory Markers
Time frame: End of each 4-week diet
Markers of appetite and food intake regulation
Time frame: End of each 4-week diet
Blood pressure
Time frame: End of each 4-week diet
Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine
Time frame: End of each 4-week diet
Change in fecal microbiota
Time frame: At baseline and after 4-weeks of each diet
Dietary Questionnaires
Time frame: At end of each 4-week diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Derived from this study: PubMed 26115560Schroeder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hypercholesterolemia, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Disease Biomarkers (time frame: End of each 4-week diet period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01617525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.