Hypercholesterolemia
Conditions
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.
Interventions
OTHERControlled Feeding Dietary Intervention
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.
Sponsors
USDA Beltsville Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Disease Biomarkers | End of each 4-week diet period | Plasma total cholesterol, HDL and LDL cholesterol, insulin, glucose, and serum triglycerides will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Markers of appetite and food intake regulation | End of each 4-week diet | Plasma adiponectin, ghrelin, PYY and leptin will be measured. |
| Blood pressure | End of each 4-week diet | — |
| Inflammatory Markers | End of each 4-week diet | 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). |
| Change in fecal microbiota | At baseline and after 4-weeks of each diet | 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. |
| Dietary Questionnaires | At end of each 4-week diet | Participants will be asked to complete questionnaires regarding acceptability, satiety, and gastrointestinal symptoms. |
| Urinary sodium excretion, potassium, urea nitrogen, phosphorus, and creatinine | End of each 4-week diet | — |
Countries
United States
Outcome results
None listed