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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379548
• Other study ID #: 04-47
• Status: Completed
• Phase: N/A
• First received: September 21, 2006
• Last updated: March 17, 2017
• Start date: November 2005
• Est. completion date: September 2014

Study information

• Verified date: March 2017
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes
• Gingival Diseases
• Inflammation
• Insulin Resistance
• Periodontal Disease
• Periodontal Diseases

Intervention

Behavioral:
• 2 groups of population responding to 2 types of diets
Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Sunstar, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Lipid profiles		before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Primary	Blood glucose levels		before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Primary	Body Fat percentage assessed by Dual X-ray Absorption		before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet
Primary	Insulin resistance assessed by HOMA		before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet