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

NCT ID: NCT00379548

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2014-09-30

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).

Conditions

Diabetes; Insulin Resistance; Inflammation; Cardiovascular Disease; Periodontal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

Control group- subjects are on the Asian diet for the entire duration of the study

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Asian and Caucasian subjects switch from an Asian Diet to a Western Diet midway through the study.

Group Type: EXPERIMENTAL

2 groups of population responding to 2 types of diets

Intervention Type: BEHAVIORAL

Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunstar, Inc.

INDUSTRY

Sponsor Role: collaborator

Joslin Diabetes Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George L King, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

Joslin Diabetes Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25226279 (View on PubMed)

Other Identifiers

04-47

Identifier Type: -

Identifier Source: org_study_id