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

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

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).

Study Overview

• Status: Completed
• Conditions: Inflammation; Cardiovascular Disease; Diabetes; Insulin Resistance; Periodontal Disease
• Intervention / Treatment: Behavioral: 2 groups of population responding to 2 types of diets

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; Control group- subjects are on the Asian diet for the entire duration of the study
Experimental: 2; 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; Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Joslin Diabetes Center
• Collaborators: Sunstar, Inc.
• Investigators: Principal Investigator: George L King, MD, Joslin Diabetes Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: September 21, 2006
• First Submitted That Met QC Criteria: September 21, 2006
• First Posted (Estimate): September 22, 2006

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Stomatognathic Diseases; Mouth Diseases; Hyperinsulinism; Cardiovascular Diseases; Inflammation; Insulin Resistance; Periodontal Diseases
• Other Study ID Numbers: 04-47