Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study

Study Overview
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Brief Summary
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We hypothesize that Asian Americans compared to Caucasians, will be at higher risk of developing a pro-inflammatory state that may contribute to the development of heart disease and diabetes when they change from a traditional Asian diet to a typical Western diet. These inflammatory responses will be reflected by the activation of monocytes as measured by protein kinase C (PKC), a known activator of monocytes. We also hypothesize that the changes of these inflammatory responses in the gingival crevicular fluid (GCF) will reflect similar changes of these markers in the plasma and monocytes. Specific aims: To compare the inflammatory responses (primarily PKC activation in monocytes), between Far-East Asian Americans and Caucasian Americans, when they change from a traditional Asian diet to a typical American diet. To correlate the biochemical changes of inflammatory responses in the plasma and monocytes with those in the gingival crevicular fluid (GCF).

Official Title
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A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets

Conditions
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Diabetes, Insulin Resistance, Inflammation, Cardiovascular Disease, Periodontal Disease

Intervention / Treatment
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* Behavioral: 2 groups of population responding to 2 types of diets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian or Far-East Asian decent Ages between 25 - 55 years old Has family history of diabetes defined as having a first degree relative diagnosed with diabetes mellitus, and/or medical history of gestational diabetes (GDM), impaired fasting glucose(IFG) and impaired glucose tolerance (IGT) BMI of 18.5 - 25.0 kg/m2 Agree to maintain constant physical activity levels for the duration of the study Agree to utilize contraception for the duration of the study (for female subjects) Have a minimum of 12 natural teeth Scoring of 2 or more on dental screening questionnaire (See appendix) Ability to communicate in English Exclusion Criteria: Acute weight loss/weight gain over the past 6 months (defined as +4 lbs or more/month) History of diabetes Current Smokers (including those who quit < 1 year) Heavy alcohol drinkers, defined as drinking more than 7 drinks/week. Those who drink alcohol will need to be reported and documented. They will be asked to maintain the levels of alcohol consumption throughout the study. Medical history of vascular diseases (CAD, MI, stroke, CABG, angioplasty), diabetes, liver disease, kidney disease, cancer, AIDS, bleeding disorders History of food allergies or to any food products in the diet menu. Enrolled in another investigational study within 1 month prior to screening for this study Vegetarian, those with significant food aversions, and anyone who cannot comply with the diet Pregnancy or breasting feeding Other autoimmune or inflammatory conditions or diseases that may compromise the patient's safety or compliance during the study on an individual basis Chronic use of antibiotics or anti-inflammatory medications (>1 month) within the past year On medications such as statins, angiotensin converting enzyme inhibitor, warfarin, aspirin or other anti-inflammatory medications. Daily multivitamins are permitted, excluding pharmacological doses of anti- oxidants will not be allowed. Individuals with dental needs requiring extensive dental restorations such as cavities, root canals, crowns, etc.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Control group- subjects are on the Asian diet for the entire duration of the study | |
| Experimental: 2<br>Asian and Caucasian subjects switch from an Asian Diet to a Western Diet midway through the study. | Behavioral: 2 groups of population responding to 2 types of diets<br>* Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid |  | before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet | 
| Lipid profiles |  | before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet | 
| Blood glucose levels |  | before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet | 
| Body Fat percentage assessed by Dual X-ray Absorption |  | before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet | 
| Insulin resistance assessed by HOMA |  | before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet |