Clinical trial NCT00379548: Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study
Official title: A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Insulin Resistance
Inflammation
Cardiovascular Disease
Periodontal Disease
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Sunstar, Inc.
First posted: 2006-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Caucasian or Far-East Asian decent
2. Ages between 25 - 55 years old
3. 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)
4. BMI of 18.5 - 25.0 kg/m2
5. Agree to maintain constant physical activity levels for the duration of the study
6. Agree to utilize contraception for the duration of the study (for female subjects)
7. Have a minimum of 12 natural teeth
8. Scoring of 2 or more on dental screening questionnaire (See appendix)
9. Ability to communicate in English

Exclusion Criteria:

1. Acute weight loss/weight gain over the past 6 months (defined as +4 lbs or more/month)
2. History of diabetes
3. Current Smokers (including those who quit \< 1 year)
4. 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.
5. Medical history of vascular diseases (CAD, MI, stroke, CABG, angioplasty), diabetes, liver disease, kidney disease, cancer, AIDS, bleeding disorders
6. History of food allergies or to any food products in the diet menu.
7. Enrolled in another investigational study within 1 month prior to screening for this study
8. Vegetarian, those with significant food aversions, and anyone who cannot comply with the diet
9. Pregnancy or breasting feeding
10. Other autoimmune or inflammatory conditions or diseases that may compromise the patient's safety or compliance during the study on an individual basis
11. Chronic use of antibiotics or anti-inflammatory medications (\>1 month) within the past year
12. 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.
13. Individuals with dental needs requiring extensive dental restorations such as cavities, root canals, crowns, etc.

Primary outcomes:
measure: Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid
timeFrame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
measure: Lipid profiles
timeFrame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
measure: Blood glucose levels
timeFrame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
measure: Body Fat percentage assessed by Dual X-ray Absorption
timeFrame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
measure: Insulin resistance assessed by HOMA
timeFrame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: George L King, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu WC, Lau KH, Matsumoto M, Moghazy D, Keenan H, King GL. Improvement of insulin sensitivity by isoenergy high carbohydrate traditional Asian diet: a randomized controlled pilot feasibility study. PLoS One. 2014 Sep 16;9(9):e106851. doi: 10.1371/journal.pone.0106851. eCollection 2014.