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

Completed · Not applicable

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

In brief

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: 1. 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. 2. To correlate the biochemical changes of inflammatory responses in the plasma and monocytes with those in the gingival crevicular fluid (GCF).

Key facts

Study ID: NCT00379548
Run by: Joslin Diabetes Center
People needed: 50
Starts: 2005-11-01
Expected to finish: 2014-09-01
Last updated by the study team: 2017-03-20

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Joslin Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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